Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial

Abstract

Background: Pain management after injury is critically important for functional recovery. Although opioids have been a mainstay for treatment of pain, they are associated with adverse events and may contribute to long-term use or abuse. Opioid-minimizing multimodal pain regimens have the potential to reduce exposure to opioids without compromising pain control. This article details an ongoing clinical trial comparing two pill-based, opioid-minimizing, multimodal pain strategies.

Methods: This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing two multimodal pain regimens in adult trauma patients. All patients 16 years and older admitted to the Red Duke Trauma Institute are eligible unless they are pregnant, a prisoner, under observation status, or a non-acute trauma patient. At admission to the trauma service, patients are enrolled and randomized to one of two multimodal pain regimens. The primary outcome is opioid use, measured by morphine milligram equivalents per patient per day. The secondary outcomes include pain scores, ventilator days, hospital and intensive care unit lengths of stay, occurrence of opioid-related complications, hospital and pharmacy costs, and incidence of hospital discharge with opioid prescription. Outcomes will be compared using Bayesian methods.

Discussion: This trial will determine the effectiveness of two multimodal pain treatment strategies on reducing in-hospital opioid exposure in adult trauma patients. Furthermore, it will compare the two strategies on pain control and patient safety. Knowledge gained in this study can improve quality of care at this hospital and other trauma centers regardless of which medication regimen proves superior.

Keywords: Opioid; acute pain; injury; trauma/ critical care.

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1

Deaths due to motor vehicle crashes and opioid and heroin overdoses. Opioid and heroin-related deaths exceed those due to motor vehicle collisions (MVC). From the Centers for Disease Control and Prevention and Insurance Institute for Highway Safety.

Figure 2

Standard Protocol Items: Recommendations for Interventional Trials diagram. The figure details the timing of enrollment activities, intervention allocation, and assessments of outcomes during the course of the clinical trial.