Multi-Modal Analgesic Strategy for Trauma: A Pragmatic Randomized Clinical Trial

Abstract

Background: An effective strategy to manage acute pain and minimize opioid exposure is needed for injured patients. In this trial, we aimed to compare 2 multimodal pain regimens (MMPRs) for minimizing opioid exposure and relieving acute pain in a busy, urban trauma center.

Methods: This was an unblinded, pragmatic, randomized, comparative effectiveness trial of all adult trauma admissions except vulnerable patient populations and readmissions. The original MMPR (IV administration, followed by oral, acetaminophen, 48 hours of celecoxib and pregabalin, followed by naproxen and gabapentin, scheduled tramadol, and as-needed oxycodone) was compared with an MMPR of generic medications, termed the Multi-Modal Analgesic Strategies for Trauma (MAST) MMPR (ie oral acetaminophen, naproxen, gabapentin, lidocaine patches, and as-needed opioids). The primary endpoint was oral morphine milligram equivalents (MMEs) per day and secondary outcomes included total MMEs during hospitalization, opioid prescribing at discharge, and pain scores.

Results: During the trial, 1,561 patients were randomized, 787 to receive the original MMPR and 774 to receive the MAST MMPR. There were no differences in demographic characteristics, injury characteristics, or operations performed. Patients randomized to receive the MAST MMPR had lower MMEs per day (34 MMEs/d; interquartile range 15 to 61 MMEs/d vs 48 MMEs/d; interquartile range 22 to 74 MMEs/d; p < 0.001) and fewer were prescribed opioids at discharge (62% vs 67%; p = 0.029; relative risk 0.92; 95% credible interval, 0.86 to 0.99; posterior probability relative risk <1 = 0.99). No clinically significant difference in pain scores were seen.

Conclusions: The MAST MMPR was a generalizable and widely available approach that reduced opioid exposure after trauma and achieved adequate acute pain control.

Trial registration: ClinicalTrials.gov NCT03472469.

Figure 1:

Consolidated Standards of Reporting Trials diagram for the Multimodal Analgesic Strategies in Trauma Trial. Of 3,385 screened patients, 1,634 were randomized. The primary reason for exclusion after randomization was refusal of consent to the use of protected health information (n = 55 [3%]). An additional 18 patients (1%) were excluded for double enrollment, readmission, incorrect patient identifier resulting in unknown enrolled patient, or identification of a vulnerable patient status. AMA, against medical advice; ED, emergency department

Figure 2:

Morphine milligram equivalents (MME) per day by treatment group and by hospital day. (A) Histogram of MME per day by multimodal pain regimen (MMPR) treatment group. (B) Average MME/day of patients per hospital day by MMPR treatment group. MAST, Multimodal Analgesic Strategies in Trauma.