Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT03472469
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2018-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'John.Harvin@uth.tmc.edu', 'phone': '(713) 500-7244', 'title': 'John A. Harvin, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From hospital admission to hospital discharge (about 30 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.', 'otherNumAtRisk': 787, 'deathsNumAtRisk': 787, 'otherNumAffected': 0, 'seriousNumAtRisk': 787, 'deathsNumAffected': 29, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.', 'otherNumAtRisk': 774, 'deathsNumAtRisk': 774, 'otherNumAffected': 0, 'seriousNumAtRisk': 774, 'deathsNumAffected': 36, 'seriousNumAffected': 36}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 787, 'numEvents': 787, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 774, 'numEvents': 774, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Use Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '74'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported.', 'unitOfMeasure': 'MME per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain as Assessed by Score on the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '735', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '4.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was only collected from 739 in the Original MMPR arm and 735 in the MAST MMPR arm.'}, {'type': 'SECONDARY', 'title': 'Pain as Assessed by Score on the Behavioral Pain Scale (BPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.0'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was only collected from 156 in the Original MMPR arm and 150 in the MAST MMPR arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discharged From the Hospital With an Opioid Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '527', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Opioid-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'title': 'Unplanned intubation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Unplanned admission to the intensive care unit', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac arrest with Cardiopulmonary resuscitation (CPR)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Ileus', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Naloxone reversal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '20093', 'groupId': 'OG000', 'lowerLimit': '9557', 'upperLimit': '42492'}, {'value': '19561', 'groupId': 'OG001', 'lowerLimit': '10238', 'upperLimit': '44795'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred.', 'unitOfMeasure': 'dollars', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacy Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '507', 'groupId': 'OG000', 'lowerLimit': '240', 'upperLimit': '1098'}, {'value': '397', 'groupId': 'OG001', 'lowerLimit': '183', 'upperLimit': '1044'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'The costs of the pain medications given during the specified time period.', 'unitOfMeasure': 'dollars', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Ventilator Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.18'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as "mean" actually refers to "marginal mean," and the data reported as "95% Confidence Interval" actually refers to a "95% Credible Interval."', 'unitOfMeasure': 'ventilator days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '5.38'}, {'value': '5.12', 'groupId': 'OG001', 'lowerLimit': '4.72', 'upperLimit': '5.55'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as "mean" actually refers to "marginal mean," and the data reported as "95% Confidence Interval" actually refers to a "95% Credible Interval."', 'unitOfMeasure': 'hospital days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Intensive Care Unti (ICU) Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.34'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.35'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as "mean" actually refers to "marginal mean," and the data reported as "95% Confidence Interval" actually refers to a "95% Credible Interval."', 'unitOfMeasure': 'ICU days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Degree to Which Function is Limited by Pain as Assessed by Percent of Predicted Daily Incentive Spirometry Volumes (Which is Based on Ideal Body Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization.', 'reportingStatus': 'POSTED', 'populationDescription': 'These data were not collected.'}, {'type': 'SECONDARY', 'title': 'Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'OG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'reportingStatus': 'POSTED', 'populationDescription': 'These data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'FG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '787'}, {'groupId': 'FG001', 'numSubjects': '774'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '787'}, {'groupId': 'FG001', 'numSubjects': '774'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'BG000'}, {'value': '774', 'groupId': 'BG001'}, {'value': '1561', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Original MMPR - Descending Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.'}, {'id': 'BG001', 'title': 'MAST MMPR - Escalating Dose Arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '63'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '62'}, {'value': '45', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '539', 'groupId': 'BG000'}, {'value': '522', 'groupId': 'BG001'}, {'value': '1061', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '487', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '726', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '787', 'groupId': 'BG000'}, {'value': '774', 'groupId': 'BG001'}, {'value': '1561', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Prior Opioid Use', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '690', 'groupId': 'BG000'}, {'value': '685', 'groupId': 'BG001'}, {'value': '1375', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with a History of Smoking', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '520', 'groupId': 'BG000'}, {'value': '524', 'groupId': 'BG001'}, {'value': '1044', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '460', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with a Positive Alcohol Screen', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '459', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '933', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Not performed', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '380', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with a Positive Drug Screen', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '635', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}, {'title': 'Not performed', 'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Score on Abbreviated Injury Scale (AIS) - Head', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Score on Abbreviated Injury Scale (AIS) - Chest', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Score on Abbreviated Injury Scale (AIS) - Abdomen', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Injury Severity Score (ISS)', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '22'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '22'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Injury Severity Score (ISS) assesses the combined effects of injuries in multiple anatomical locations and ranges from from 1 to 75, with 75 being the most severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of participants with rib fractures', 'classes': [{'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '356', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of rib fractures', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'rib fractures', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of participants with flail segment', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Flail segment is the condition of having three or more contiguous ribs fractured in two or more places', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with long bone fracture', 'classes': [{'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with vertebral body fracture', 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with pelvis or acetabulum fracture', 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with traumatic brain injury', 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Unit of admission', 'classes': [{'categories': [{'title': 'Floor', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}, {'title': 'Intermediate unit', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '380', 'groupId': 'BG002'}]}, {'title': 'Intensive care unit', 'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '552', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who underwent laparotomy procedure', 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who underwent thoracotomy procedure', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who underwent amputation procedure', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-02', 'size': 1339704, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-14T17:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1561}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2020-06-23', 'completionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2018-03-13', 'dispFirstSubmitQcDate': '2020-06-23', 'resultsFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2018-03-20', 'dispFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-16', 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Use Per Day', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported.'}], 'secondaryOutcomes': [{'measure': 'Pain as Assessed by Score on the Numeric Rating Scale (NRS)', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants.'}, {'measure': 'Pain as Assessed by Score on the Behavioral Pain Scale (BPS)', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants.'}, {'measure': 'Number of Participants Discharged From the Hospital With an Opioid Prescription', 'timeFrame': 'Up to 30 days'}, {'measure': 'Number of Participants With Any Opioid-related Complications', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent.'}, {'measure': 'Overall Costs', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred.'}, {'measure': 'Pharmacy Costs', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'The costs of the pain medications given during the specified time period.'}, {'measure': 'Number of Ventilator Days', 'timeFrame': '30 days', 'description': 'The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as "mean" actually refers to "marginal mean," and the data reported as "95% Confidence Interval" actually refers to a "95% Credible Interval."'}, {'measure': 'Number of Hospital Days', 'timeFrame': '30 days', 'description': 'The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as "mean" actually refers to "marginal mean," and the data reported as "95% Confidence Interval" actually refers to a "95% Credible Interval."'}, {'measure': 'Number of Intensive Care Unti (ICU) Days', 'timeFrame': '30 days', 'description': 'The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as "mean" actually refers to "marginal mean," and the data reported as "95% Confidence Interval" actually refers to a "95% Credible Interval."'}, {'measure': 'Degree to Which Function is Limited by Pain as Assessed by Percent of Predicted Daily Incentive Spirometry Volumes (Which is Based on Ideal Body Weight)', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)', 'description': 'Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization.'}, {'measure': 'Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain', 'timeFrame': 'until discharge from hospital or 30 days post admission (whichever is sooner)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonspecific Pain Post Traumatic Injury']}, 'referencesModule': {'references': [{'pmid': '30206549', 'type': 'BACKGROUND', 'citation': 'Harvin JA, Green CE, Vincent LE, Motley KL, Podbielski J, Miller CC, Tyson JE, Holcomb JB, Wade CE, Kao LS. Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial. Trauma Surg Acute Care Open. 2018 Aug 19;3(1):e000192. doi: 10.1136/tsaco-2018-000192. eCollection 2018.'}, {'pmid': '33486130', 'type': 'RESULT', 'citation': 'Harvin JA, Albarado R, Truong VTT, Green C, Tyson JE, Pedroza C, Wade CE, Kao LS; MAST Study Group. Multi-Modal Analgesic Strategy for Trauma: A Pragmatic Randomized Clinical Trial. J Am Coll Surg. 2021 Mar;232(3):241-251.e3. doi: 10.1016/j.jamcollsurg.2020.12.014. Epub 2021 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a comparative effectiveness study of current pain management strategies in acutely injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies will be compared \\[original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to the trauma service who are 16 years and older.\n\nExclusion Criteria:\n\n* pregnant\n* prisoner\n* patients placed in observation (i.e. not admitted to the hospital)'}, 'identificationModule': {'nctId': 'NCT03472469', 'acronym': 'MAST', 'briefTitle': 'MAST Trial: Multi-modal Analgesic Strategies in Trauma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'MAST Trial: Multi-modal Analgesic Strategies in Trauma', 'orgStudyIdInfo': {'id': 'HSC-MS-18-0036'}, 'secondaryIdInfos': [{'id': 'KL2TR000370', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR000370', 'type': 'NIH'}, {'id': 'UL1TR000371', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000371', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Original MMPR - descending dose arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter.', 'interventionNames': ['Drug: Acetaminophen IV/PO', 'Drug: Acetaminophen PO', 'Drug: Ketorolac', 'Drug: Celebrex', 'Drug: Naproxen', 'Drug: Tramadol', 'Drug: Pregabalin', 'Drug: Gabapentin', 'Drug: Lidocaine', 'Drug: Opioids', 'Drug: Regional anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAST MMPR - escalating dose arm', 'description': 'Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter.', 'interventionNames': ['Drug: Acetaminophen PO', 'Drug: Ketorolac', 'Drug: Naproxen', 'Drug: Gabapentin', 'Drug: Lidocaine', 'Drug: Opioids', 'Drug: Regional anesthesia']}], 'interventions': [{'name': 'Acetaminophen IV/PO', 'type': 'DRUG', 'description': 'Acetaminophen 1g IV/PO every 6 hours', 'armGroupLabels': ['Original MMPR - descending dose arm']}, {'name': 'Acetaminophen PO', 'type': 'DRUG', 'description': 'Acetaminophen 1g PO every 6 hours', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'Ketorolac 30mg IV once', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}, {'name': 'Celebrex', 'type': 'DRUG', 'description': 'Celebrex 200mg PO every 12 hours', 'armGroupLabels': ['Original MMPR - descending dose arm']}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Naproxen 500mg PO every 12 hours', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': 'Tramadol 100mg PO every 6 hours', 'armGroupLabels': ['Original MMPR - descending dose arm']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Pregabalin 100mg PO every 8 hours', 'armGroupLabels': ['Original MMPR - descending dose arm']}, {'name': 'Gabapentin', 'type': 'DRUG', 'description': 'Gabapentin 300mg PO every 8 hours', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine patch every 12 hours', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}, {'name': 'Opioids', 'type': 'DRUG', 'description': 'Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}, {'name': 'Regional anesthesia', 'type': 'DRUG', 'description': 'Regional anesthesia', 'armGroupLabels': ['MAST MMPR - escalating dose arm', 'Original MMPR - descending dose arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'John Harvin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'John Andrew Harvin', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}