MAST Trial: Multi-modal Analgesic Strategies in Trauma

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Nonspecific Pain Post Traumatic Injury

Treatments: Drug: Naproxen; Drug: Opioids; Drug: Tramadol; Drug: Pregabalin; Drug: Acetaminophen IV/PO; Drug: Regional anesthesia; Drug: Gabapentin; Drug: Acetaminophen PO; Drug: Celebrex; Drug: Lidocaine; Drug: Ketorolac

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03472469

HSC-MS-18-0036

UL1TR000371 (U.S. NIH Grant/Contract)

KL2TR000370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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].

Enrollment: 1,561 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients admitted to the trauma service who are 16 years and older.

Exclusion criteria

• pregnant
• prisoner
• patients placed in observation (i.e. not admitted to the hospital)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,561 participants in 2 patient groups

Original MMPR - descending dose arm

Active Comparator group

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.

Treatment:

Drug: Gabapentin

Drug: Acetaminophen PO

Drug: Celebrex

Drug: Acetaminophen IV/PO

Drug: Naproxen

Drug: Tramadol

Drug: Opioids

Drug: Lidocaine

Drug: Pregabalin

Drug: Ketorolac

Drug: Regional anesthesia

MAST MMPR - escalating dose arm

Active Comparator group

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.

Treatment:

Drug: Gabapentin

Drug: Acetaminophen PO

Drug: Naproxen

Drug: Opioids

Drug: Lidocaine

Drug: Ketorolac

Drug: Regional anesthesia