Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-21 @ 9:41 PM
Study NCT ID:
NCT04761302
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2021-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hans.hess1@upr.edu', 'phone': '787-365-5755', 'title': 'Dr. Hans Hess', 'organization': 'University of Puerto Rico: Department of Orthopedic Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.\n\nIntravenous ketorolac and oral acetaminophen: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nIntravenous morphine and oral oxycodone: Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.\n\nIntravenous ketorolac and oral acetaminophen: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nIntravenous morphine and oral oxycodone: Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Non-Union', 'notes': 'Non-Union was defined as a delayed union that did not resolve at 9 months after surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed Union', 'notes': 'Delayed union was defined as a lack of callous formation at 6 months after surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '12hrs VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nUse of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '2.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.215', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.445', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 12', 'description': 'Visual Analog Scale; 0-10 (10 indicates highest degree of pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '24hrs VAS Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.\n\nIntravenous ketorolac and oral acetaminophen: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nIntravenous morphine and oral oxycodone: Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.\n\nIntravenous ketorolac and oral acetaminophen: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nIntravenous morphine and oral oxycodone: Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '2.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.300', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 24', 'description': 'Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '36hrs VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nUse of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '2.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.359', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 36', 'description': 'Visual Analog Scale; 0-10 (10 indicates highest degree of pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '48hrs VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nUse of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '2.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.152', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 48', 'description': 'Visual Analog Scale; 0-10 (10 indicates highest degree of pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '12hrs MME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '12.1', 'spread': '11.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 12', 'description': 'Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '24hrs MME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '21.49', 'spread': '22.4', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '13.6', 'groupId': 'OG002'}, {'value': '28.8', 'spread': '20.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 24', 'description': 'Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '36hrs MME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '29.9', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '15.9', 'groupId': 'OG002'}, {'value': '36.6', 'spread': '29.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 36', 'description': 'Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '48hrs MME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '37.8', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '48.0', 'spread': '35.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at postoperative hour 48', 'description': 'Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.\n\nUse of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture: This is a randomized controlled, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.'}, {'id': 'OG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'OG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.354', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.455', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'A priori threshold for statistical significance: \\<0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Determined by discharge date', 'description': 'Time from intervention to discharge', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'FG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'FG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'FG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'BG001', 'title': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'BG002', 'title': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.'}, {'id': 'BG003', 'title': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone', 'description': 'Group 4 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '42'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '60'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '42'}, {'value': '40', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '60'}, {'value': '36', 'groupId': 'BG004', 'lowerLimit': '24', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '5.90', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '6.21', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '26.7', 'spread': '6.2', 'groupId': 'BG003'}, {'value': '26.8', 'spread': '6.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoker status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Smoker', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Non-smoker', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-06', 'size': 323900, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_004.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-08T11:41', 'hasProtocol': True}, {'date': '2020-10-14', 'size': 161922, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_005.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-08T11:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2021-02-16', 'resultsFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-25', 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12hrs VAS Pain Scores', 'timeFrame': 'Measured at postoperative hour 12', 'description': 'Visual Analog Scale; 0-10 (10 indicates highest degree of pain)'}, {'measure': '24hrs VAS Pain Score', 'timeFrame': 'Measured at postoperative hour 24', 'description': 'Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)'}, {'measure': '36hrs VAS Pain Scores', 'timeFrame': 'Measured at postoperative hour 36', 'description': 'Visual Analog Scale; 0-10 (10 indicates highest degree of pain)'}, {'measure': '48hrs VAS Pain Scores', 'timeFrame': 'Measured at postoperative hour 48', 'description': 'Visual Analog Scale; 0-10 (10 indicates highest degree of pain)'}, {'measure': '12hrs MME', 'timeFrame': 'Measured at postoperative hour 12', 'description': 'Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)'}, {'measure': '24hrs MME', 'timeFrame': 'Measured at postoperative hour 24', 'description': 'Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)'}, {'measure': '36hrs MME', 'timeFrame': 'Measured at postoperative hour 36', 'description': 'Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)'}, {'measure': '48hrs MME', 'timeFrame': 'Measured at postoperative hour 48', 'description': 'Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)'}], 'secondaryOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': 'Determined by discharge date', 'description': 'Time from intervention to discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid use', 'Post-operative pain', 'Analgesic use', 'Femur fracture', 'Tibia fracture', 'Intramedullary Nailing'], 'conditions': ['Femur Fracture', 'Tibial Fractures']}, 'referencesModule': {'references': [{'pmid': '38579315', 'type': 'DERIVED', 'citation': 'Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.', 'detailedDescription': 'The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with tibial and femoral shaft fractures\n2. Patients undergoing intramedullary nailing\n3. Willing to participate in the protocol\n\nExclusion Criteria:\n\n1. Chronic pain disorder (daily use of oral opioids)\n2. Allergy or hypersensitivity to non steroid anti-inflammatory drug\n3. Impaired renal, cardiac, or hepatic function\n4. History of gastrointestinal bleeding or substance abuse'}, 'identificationModule': {'nctId': 'NCT04761302', 'briefTitle': 'Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures', 'orgStudyIdInfo': {'id': 'A9290220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen', 'description': 'Group 1 will be composed of tibial fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.', 'interventionNames': ['Drug: Intravenous ketorolac and oral acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone', 'description': 'Group 2 will be composed of tibial fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.', 'interventionNames': ['Drug: Intravenous morphine and oral oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen', 'description': 'Group 3 will be composed of femoral fracture patients receiving the following standard pain control protocol: ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group. Patients who determine pain to be unbearable and wish to opt out of the non-opioid group will receive may do so.', 'interventionNames': ['Drug: Intravenous ketorolac and oral acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone', 'description': 'Group 4 will be composed of femoral fracture patients receiving the following pain control protocol: morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.', 'interventionNames': ['Drug: Intravenous morphine and oral oxycodone']}], 'interventions': [{'name': 'Intravenous ketorolac and oral acetaminophen', 'type': 'DRUG', 'description': 'ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group', 'armGroupLabels': ['Group 1: Tibial Fracture Patients Receiving Intravenous Ketorolac and oral acetaminophen', 'Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen']}, {'name': 'Intravenous morphine and oral oxycodone', 'type': 'DRUG', 'description': 'Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.', 'armGroupLabels': ['Group 2: Tibial Fracture Patients Receiving Intravenous Morphine and oral oxycodone', 'Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and oral oxycodone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University District Hospital', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Luis F. Lojo-Sojo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}