Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT02700451
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2016-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Sponsor:
Organization:
Raw JSON
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[{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gangh@HSS.EDU', 'phone': '917-260-4603', 'title': 'Catherine Himo Gang', 'organization': 'HospitalSS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': 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{'term': 'Radiographic', 'notes': 'adjacent segment degeneration pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'notes': 'oliguria urinary retention hematuria Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'notes': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'notes': 'prolonged drainage seroma swelling redness pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'notes': 'ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perioperative Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'OME total in the first 72H', 'categories': [{'measurements': [{'value': '86.25', 'groupId': 'OG000', 'lowerLimit': '39.6', 'upperLimit': '245.55'}, {'value': '306.6', 'groupId': 'OG001', 'lowerLimit': '161', 'upperLimit': '423'}, {'value': '192.4', 'groupId': 'OG002', 'lowerLimit': '91.55', 'upperLimit': '372.85'}]}]}, {'title': 'OME total to discharge', 'categories': [{'measurements': [{'value': '88.95', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '284.03'}, {'value': '324', 'groupId': 'OG001', 'lowerLimit': '169', 'upperLimit': '471'}, {'value': '237.9', 'groupId': 'OG002', 'lowerLimit': '91.55', 'upperLimit': '467.05'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p = 0.05', 'groupDescription': 'The distribution of OME total in the first 72H is the same across these arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The thresholds for statistical significant was p = 0.05', 'groupDescription': 'The distribution of OME total to discharge is the same across these arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital stay (2-4 days)', 'description': 'Measure the impact of treatment on total opioid use during the hospital stay', 'unitOfMeasure': 'oral morphine equivalents (OME) (mmg)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Use at 4-6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'No opioid use', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': 'Opioid use', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Similar Distribution of opioid use between the 3 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-6 weeks', 'description': 'Track opioid use after discharge for the first 4-6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Opioid Use at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'No opioid use', 'measurements': [{'value': '32', 'groupId': 'OG000'}, 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'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'No opioid use', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'title': 'Opioid use', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Track opioid use after discharge for the first 1 year; assess for continued opioid use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Opioid Use at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'No opioid use', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': 'Opioid use', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Track total opioid use after discharge for the first 2 years; assess for continued opioid use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Numerical Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'POD1 - Current pain level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '58'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '72'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '25.5', 'upperLimit': '67'}]}]}, {'title': 'POD1 - Best pain level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '40'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '34.5'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '12.5', 'upperLimit': '51'}]}]}, {'title': 'POD1 - Worst pain level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '73'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '66.3', 'upperLimit': '97.8'}, {'value': '74', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '86.5'}]}]}, {'title': 'POD3 - Current pain level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '76.8'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '25.5', 'upperLimit': '74'}, {'value': '52', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '65.0'}]}]}, {'title': 'PDO3 - Best pain level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '36'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '50'}, {'value': '39', 'groupId': 'OG002', 'lowerLimit': '18.8', 'upperLimit': '51'}]}]}, {'title': 'POD3 - Worst pain level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '88'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '93.5'}, {'value': '72.5', 'groupId': 'OG002', 'lowerLimit': '62.8', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.732', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Current pain level is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.896', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Best pain level is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Worst pain level is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.325', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Current pain level is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.283', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Best pain level is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.610', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Worst pain level is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEDIAN', 'timeFrame': '1 days and 3 days', 'description': 'Validated pain scale; will be completed by patient Minimum Score: 0 \\& Maximum score 100 A lower score is representative of a low pain level', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on patient with data completed.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'POD1 - Pain has interfered with General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '10'}]}]}, {'title': 'POD1 - Pain has interfered with Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'POD1 - Pain has interfered with Walking Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '9'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5.25', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'POD1 - Pain has interfered with Normal work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '10'}]}]}, {'title': 'POD1 - Pain has interfered with Relation with other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3.75'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5.75'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'POD1 - Pain has interfered with Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6.75'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8.75'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2.75', 'upperLimit': '8'}]}]}, {'title': 'POD1 - Pain has interfered with Enjoyment of life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8.75'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '10'}]}]}, {'title': 'POD3 - Pain has interfered with General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '10'}]}]}, {'title': 'POD3 - Pain has interfered with Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6.75'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '7'}]}]}, {'title': 'POD3 - Pain has interfered with Walking Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '7'}]}]}, {'title': 'POD3 - Pain has interfered with Normal work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5.25', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '6.25', 'upperLimit': '10'}]}]}, {'title': 'POD3 - Pain has interfered with Relation with other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'POD3 - Pain has interfered with Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '7.75'}]}]}, {'title': 'POD3 - Pain has interfered with Enjoyment of life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.294', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.082', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.117', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.061', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.681', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.405', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.458', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.482', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.544', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.580', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day and 3 days', 'description': 'The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Opioid Related Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'POD1 - Nausea?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Vomiting?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Constipation?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Difficulty passing urine?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Difficulty concentrating?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Drowsiness/Difficulty Staying Awake?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Lightheaded or dizzy?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Feeling confused?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Fatigue?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Itchiness?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Dry mouth?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'POD1 - Headache?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Nausea?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Vomiting?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Constipation?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Difficulty passing urine?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Difficulty concentrating?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Drowsiness/Difficulty Staying Awake?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Lightheaded or dizzy?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Feeling confused?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Fatigue?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Itchiness?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Dry mouth?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'POD3 - Headache?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Perioperative Complications - Drain Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'Total Drain output 24H', 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000', 'lowerLimit': '135', 'upperLimit': '400'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '150', 'upperLimit': '348.75'}, {'value': '240', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '390'}]}]}, {'title': 'Total Drain output 48H', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000', 'lowerLimit': '203.75', 'upperLimit': '530'}, {'value': '305', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '515'}, {'value': '320', 'groupId': 'OG002', 'lowerLimit': '240', 'upperLimit': '520'}]}]}, {'title': 'Total Drain output 72H', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000', 'lowerLimit': '203.75', 'upperLimit': '620'}, {'value': '335', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '585'}, {'value': '340', 'groupId': 'OG002', 'lowerLimit': '240', 'upperLimit': '520'}]}]}, {'title': 'Total Drain output at discharge', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000', 'lowerLimit': '203.75', 'upperLimit': '635'}, {'value': '335', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '605'}, {'value': '340', 'groupId': 'OG002', 'lowerLimit': '240', 'upperLimit': '535'}]}]}], 'analyses': [{'pValue': '0.928', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of Total Drain output at 24H is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.906', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of Total Drain output at 48H is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.926', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of Total Drain output at 72H is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.934', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of Total Drain output at Discharge is the same across the 3 arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed data'}, {'type': 'SECONDARY', 'title': 'Perioperative Complications - Transfusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'No transfusion', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}, {'title': 'Transfusion', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Proportion of patient receiving at least 1 transfusion is the same across the 3 arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed data'}, {'type': 'SECONDARY', 'title': 'Days to Walk 50 ft With PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'POD0', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}, {'title': 'POD1', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}, {'title': 'POD2 and after', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0792', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Days needed to be able to walk 50ft with PT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000', 'lowerLimit': '43.25', 'upperLimit': '91.25'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '100'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '47', 'upperLimit': '91.5'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of Length of stay in day is the same across these arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The distribution of Length of stay in hour is the same across these arms', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEAN', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Will record date of discharge', 'unitOfMeasure': 'Hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Veterans Rand - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'PCS score', 'categories': [{'measurements': [{'value': '34.7', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '34.5', 'spread': '9.7', 'groupId': 'OG002'}]}]}, {'title': 'MCS Score', 'categories': [{'measurements': [{'value': '43.9', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '42.0', 'spread': '7.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.974', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Comparison of the PCS score between the 3 arms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.444', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Comparison of the MCS between the 3 ams', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '40.6', 'spread': '15.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.215', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with pre-operative ODI'}, {'type': 'SECONDARY', 'title': 'Veterans Rand - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'PCS score', 'categories': [{'measurements': [{'value': '43.1', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '42.3', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'MCS score', 'categories': [{'measurements': [{'value': '45.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '44.3', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '4.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Comparison PCS score between the 3 arms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}, {'pValue': '0.767', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Comparison MCS score between the 3 arms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow up', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '13.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.191', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two-sided 95% confidence interval'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow up', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'Does not Apply', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Early retirement', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Complete disability', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Lighter job', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Original job. part time', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Original job, full time', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow up', 'description': 'Record return to work', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Veterans Rand - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'PCS score', 'categories': [{'measurements': [{'value': '48.1', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '47.6', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '48.4', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'MCS score', 'categories': [{'measurements': [{'value': '42.8', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow up', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '17.8', 'spread': '14.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow up', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'Does not Apply', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Early retirement', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Complete disability', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Lighter job', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Original job, part time', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Original job, full time', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year follow up', 'description': 'Record return to work', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numerical Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': '1-year - Current pain level', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '26.5'}]}]}, {'title': '1-year - Best pain level', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '22'}]}]}, {'title': '1-year - Worst pain level', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '41'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '45.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year follow up', 'description': 'Validated pain scale; will be completed by patient Minimum Score: 0 \\& Maximum score 100 A lower score is representative of a low pain level', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Veterans Rand - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': 'PCS score', 'categories': [{'measurements': [{'value': '46.6', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '51.2', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '51.1', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'MCS score', 'categories': [{'measurements': [{'value': '46.4', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '46.7', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year follow up', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '16.0', 'spread': '15.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year follow up', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'categories': [{'title': 'Does not Apply', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Early retirement', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Complete disability', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Lighter job', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Original job, part time', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Original job, full time', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 year follow up', 'description': 'Record return to work', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient treated Per-Protocol with completed follow-up'}, {'type': 'SECONDARY', 'title': 'Numerical Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'OG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'classes': [{'title': '2 year - Current pain level', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '41'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23.5'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '30.5'}]}]}, {'title': '2 year - Best pain level', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.25'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '19.25'}]}]}, {'title': '2 year - Worst pain level', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28.5'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 year follow up', 'description': 'Validated pain scale; will be completed by patient Minimum Score: 0 \\& Maximum score 100 A lower score is representative of a low pain level', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'FG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'FG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Discontinued intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '14'}]}]}], 'preAssignmentDetails': 'Assessed for eligibility (n= 1,372) Excluded (n= 1,194)\n\n* Not meeting inclusion criteria (n= 1,137)\n* Declined to participate (n= 132)\n* Other reasons (n= 103)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Ketorolac', 'description': 'IV Ketorolac arm\n\nKetorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'BG001', 'title': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm\n\nPlacebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'BG002', 'title': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm\n\nAcetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '57.0', 'spread': '11.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis performed on Per-Protocol'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-23', 'size': 765978, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-05T12:46', 'hasProtocol': True}, {'date': '2017-10-30', 'size': 429167, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-23T15:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2016-02-18', 'resultsFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-16', 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative Opioid Use', 'timeFrame': 'Hospital stay (2-4 days)', 'description': 'Measure the impact of treatment on total opioid use during the hospital stay'}], 'secondaryOutcomes': [{'measure': 'Opioid Use at 4-6 Weeks', 'timeFrame': '4-6 weeks', 'description': 'Track opioid use after discharge for the first 4-6 weeks'}, {'measure': 'Opioid Use at 3 Months', 'timeFrame': '3 months', 'description': 'Track opioid use after discharge for the first 3 months; assess for continued opioid use'}, {'measure': 'Opioid Use at 1 Year', 'timeFrame': '1 year', 'description': 'Track opioid use after discharge for the first 1 year; assess for continued opioid use'}, {'measure': 'Opioid Use at 2 Years', 'timeFrame': '2 years', 'description': 'Track total opioid use after discharge for the first 2 years; assess for continued opioid use'}, {'measure': 'Numerical Pain Rating Scale', 'timeFrame': '1 days and 3 days', 'description': 'Validated pain scale; will be completed by patient Minimum Score: 0 \\& Maximum score 100 A lower score is representative of a low pain level'}, {'measure': 'Brief Pain Inventory', 'timeFrame': '1 day and 3 days', 'description': 'The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring.'}, {'measure': 'Opioid Related Side Effects', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded'}, {'measure': 'Perioperative Complications - Drain Output', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded'}, {'measure': 'Perioperative Complications - Transfusion Rate', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded'}, {'measure': 'Days to Walk 50 ft With PT', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Days needed to be able to walk 50ft with PT'}, {'measure': 'Length of Stay', 'timeFrame': 'Hospital Stay (1-4 days)', 'description': 'Will record date of discharge'}, {'measure': 'Veterans Rand - 12', 'timeFrame': 'pre-operative', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': 'pre-operative', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.'}, {'measure': 'Veterans Rand - 12', 'timeFrame': '3 month follow up', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '3 month follow up', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.'}, {'measure': 'Return to Work', 'timeFrame': '3 month follow up', 'description': 'Record return to work'}, {'measure': 'Veterans Rand - 12', 'timeFrame': '1 year follow up', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '1 year follow up', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.'}, {'measure': 'Return to Work', 'timeFrame': '1 year follow up', 'description': 'Record return to work'}, {'measure': 'Numerical Pain Rating Scale', 'timeFrame': '1 year follow up', 'description': 'Validated pain scale; will be completed by patient Minimum Score: 0 \\& Maximum score 100 A lower score is representative of a low pain level'}, {'measure': 'Veterans Rand - 12', 'timeFrame': '2 year follow up', 'description': 'The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.\n\nThis score range apply to both PCS and MCS.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '2 year follow up', 'description': 'The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.'}, {'measure': 'Return to Work', 'timeFrame': '2 year follow up', 'description': 'Record return to work'}, {'measure': 'Numerical Pain Rating Scale', 'timeFrame': '2 year follow up', 'description': 'Validated pain scale; will be completed by patient Minimum Score: 0 \\& Maximum score 100 A lower score is representative of a low pain level'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IV acetaminophen', 'IV Ketorolac', 'Post-operative analgesia', 'Opioid use'], 'conditions': ['Lumbar Osteoarthritis', 'Spondylosis', 'Lumbar Disc Disease', 'Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects.\n\nThe purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function \\[quicker ambulation with physical therapy (PT), earlier return to work, etc.\\].', 'detailedDescription': 'Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows:\n\n* Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS)\n* Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey\n\nThe primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75\n* Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach\n* No history of long term opioid use (daily or almost daily opioid use \\> 2 weeks) and not on opiates at time of presentation to clinic\n\nExclusion Criteria:\n\n* Documented allergy to NSAIDs or Acetaminophen\n* History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine \\> 1.5 mg/dL), Glucocorticoid use within 1 month of surgery\n* Current smokers (quite date \\< 30 days ago)\n* Revision for pseudarthrosis\n* Patients who are unable to physically or mentally provide consent to the study procedures.'}, 'identificationModule': {'nctId': 'NCT02700451', 'briefTitle': 'Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes', 'orgStudyIdInfo': {'id': '2014-333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Intravenous (IV) Placebo', 'description': 'IV Placebo arm', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IV Ketorolac', 'description': 'IV Ketorolac arm', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'EXPERIMENTAL', 'label': 'IV Acetaminophen', 'description': 'IV Acetaminophen arm', 'interventionNames': ['Drug: Acetaminophen']}], 'interventions': [{'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': 'Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.\n\nAge 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.', 'armGroupLabels': ['IV Ketorolac']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol, Ofirmev'], 'description': 'Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.', 'armGroupLabels': ['IV Acetaminophen']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.', 'armGroupLabels': ['Intravenous (IV) Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Catherine Himo Gang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Manager for Spine Research'}, {'name': 'Harvinder Sandhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Orthopedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}