Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT03783702
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2018-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pain Control Following Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nfa@stanford.edu', 'phone': '3109407055', 'title': 'Noel Ayoub', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use\n\nSelection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up\n\nLack of blinding and placebo were additional limitations'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the one week period after surgery for each participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for preoperative visit (the day before surgery)', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '26.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score was collected for postoperative day 1', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '23.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for postoperative day 2', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '19.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for postoperative day 3', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '18.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for postoperative day 4', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '19.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for postoperative day 5', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for postoperative day 6', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average pain score will be collected for postoperative day 7', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Medication Log', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'title': 'Oxycodone POD1', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone POD2', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone POD3', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone POD4', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone POD5', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone POD6', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone POD7', 'categories': [{'measurements': [{'value': '0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD1', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD2', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD3', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD4', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD5', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD6', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen POD7', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD1', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD2', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD3', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD4', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD5', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD6', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ibuprofen POD7', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative day 1 to 7', 'description': 'Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.', 'unitOfMeasure': 'Average number of medication doses/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BPI score will be collected at the preoperative visit', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 1', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 2', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 3', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 4', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 5', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 6', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average BPI score will be collected for postoperative day 7', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected at the preoperative visit', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '31.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 1', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '24.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 2', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '17.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 3', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 4', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '17.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 5', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '14.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 6', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 7', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'FG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics\n3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'BG001', 'title': 'Control Group', 'description': '1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours\n2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '16.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior sinus surgery', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lund-mackay score', 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Lund-Mackay scoring system is a validated categorical scale used to define the extent of sinonasal disease on CT. The bilateral maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinuses are scored from 0-2, with 0 correlating to a normal sinus, 1 to partial opacification, and 2 to a fully opacified sinus. The bilateral ostiomeatal complexes are scored 0 if patent or 2 if obstructed. The total score ranges from 0 to 24, with 24 representing the most extensive disease.\n\nLund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg 1997; 117:S35-40.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total baseline SNOT-22 score', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '20.1', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '19.8', 'groupId': 'BG001'}, {'value': '40.5', 'spread': '19.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SNOT-22 is a validated, disease-specific questionnaire in which patients report the presence and severity of 22 commonly experienced symptoms and social consequences of chronic rhinosinusitis over the prior 2-week period. Each question scales from 0 to 5, with 0 indicating "no problem" and 5 "problem as bad as it can be." The highest possible score is 110, corresponding to the most severe symptoms.\n\nHopkins C, Gillett S, Black R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol 2009; 34:447-54.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-07', 'size': 345270, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-09T16:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-07', 'studyFirstSubmitDate': '2018-12-19', 'resultsFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-07', 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for preoperative visit (the day before surgery)', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score was collected for postoperative day 1', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for postoperative day 2', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for postoperative day 3', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for postoperative day 4', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for postoperative day 5', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for postoperative day 6', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Pain Severity', 'timeFrame': 'Average pain score will be collected for postoperative day 7', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.'}, {'measure': 'Medication Log', 'timeFrame': 'Postoperative day 1 to 7', 'description': 'Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.'}], 'secondaryOutcomes': [{'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'BPI score will be collected at the preoperative visit', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 1', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 2', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 3', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 4', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 5', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 6', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Brief Pain Inventory (BPI) Score', 'timeFrame': 'Average BPI score will be collected for postoperative day 7', 'description': 'The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).\n\nKeller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected at the preoperative visit', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 1', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 2', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 3', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 4', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 5', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 6', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}, {'measure': 'Severity of Epistaxis', 'timeFrame': 'Epistaxis severity will be collected for postoperative day 7', 'description': 'A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sinusitis', 'Opioid Use', 'Opioid Abuse', 'Narcotic Use', 'Otolaryngologic Disease', 'Postoperative Pain', 'Pain']}, 'referencesModule': {'references': [{'pmid': '20058315', 'type': 'BACKGROUND', 'citation': 'Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.'}, {'pmid': '29460670', 'type': 'BACKGROUND', 'citation': 'Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.'}, {'pmid': '29446449', 'type': 'BACKGROUND', 'citation': 'Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.'}, {'pmid': '29557264', 'type': 'BACKGROUND', 'citation': 'Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.'}, {'pmid': '34351376', 'type': 'DERIVED', 'citation': "Ayoub NF, Choby G, Turner JH, Abuzeid WM, Raviv JR, Thamboo A, Ma Y, Chandra RK, Chowdhury NI, Stokken JK, O'Brien EK, Shah S, Akbar N, Roozdar P, Nayak JV, Patel ZM, Hwang PH. Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Sep 1;147(9):811-819. doi: 10.1001/jamaoto.2021.1839."}]}, 'descriptionModule': {'briefSummary': "Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).\n\nThis prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI).\n\nThe results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* English-speaking\n* Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)\n* Can commit to follow up for at least one postoperative visit\n\nExclusion Criteria:\n\nPatients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery)\n\n* Doyle splints to be used\n* Alcohol or opioid use disorder\n* History of chronic pain disorders\n* Regular use of acetaminophen/NSAIDS (\\>4x per week)\n* Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average.\n* Gastrointestinal ulcers or bleeding\n* Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate \\<60)\n* Liver cirrhosis or other hepatic impairment\n* Prior adverse reaction to opioids or NSAIDS\n* Other contraindications to any drug classes in either group.'}, 'identificationModule': {'nctId': 'NCT03783702', 'briefTitle': 'Pain Control Following Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': '46384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.', 'interventionNames': ['Drug: OxyCODONE 5 Mg (milligram) Oral Tablet', 'Drug: Ibuprofen 600 Mg (milligram) Oral Tablet', 'Drug: Acetaminophen 650 MG (milligram) Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).', 'interventionNames': ['Drug: OxyCODONE 5 Mg (milligram) Oral Tablet', 'Drug: Acetaminophen 650 MG (milligram) Oral Tablet']}], 'interventions': [{'name': 'OxyCODONE 5 Mg (milligram) Oral Tablet', 'type': 'DRUG', 'description': 'Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Ibuprofen 600 Mg (milligram) Oral Tablet', 'type': 'DRUG', 'description': 'Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.', 'armGroupLabels': ['Experimental group']}, {'name': 'Acetaminophen 650 MG (milligram) Oral Tablet', 'type': 'DRUG', 'description': 'All patients will receive acetaminophen as the first-line analgesic.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Vancouver', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'Endeavor Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor', 'investigatorFullName': 'Peter Hwang', 'investigatorAffiliation': 'Stanford University'}}}}