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

https://doi.org/10.1016/j.jamcollsurg.2020.12.014Get rights and content

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.

Section snippets

Methods

The MAST trial was a pragmatic, randomized, comparative effectiveness trial comparing the original MMPR with the MAST MMPR. Its rationale and design have been detailed previously.9 IRB approval was obtained on March 2, 2018. Enrollment took place between April 2, 2018 and March 31, 2019.

Results

During the 12-month period, 3,385 patients were screened for eligibility; 34 eligible patients were not included; 1,634 were randomized; 73 were excluded after randomization (almost all because they refused consent or were ineligible for the trial); and 1,561 were included in the final analysis (Fig. 1). Median age of patients was 45 years (IQR 29 to 63 years), 68% were male, 29% were smokers, 12% reported a history of opioid use, and 24% had a positive urine drug screen on admission (Table 2).

Discussion

In this large, pragmatic randomized trial of adult injured patients, the use of the widely available MAST MMPR reduced inpatient opioid exposure and opioid prescribing at discharge with similar pain scores compared with our original MMPR. This finding was contrary to our hypothesis.

Overall, the MAST trial demonstrates that an opioid-minimizing acute pain strategy is effective and feasible in such injured patients. We enrolled patients admitted to the adult trauma service only. Because a large

Conclusions

The MAST MMPR reduced opioid exposure and discharge from the hospital with an opioid prescription while achieving similar pain control after trauma. These findings underscore the efficacy of opioid-minimizing strategies after trauma and the MAST MMPR has become usual practice for injured patients admitted to our trauma center.

Acknowledgment

The authors would like to acknowledge the residents and fellows of the Red Duke Trauma Center at Memorial Hermann Hospital-Texas Medical Center and the McGovern Medical School at UT Health for their active participation in and support of this trial. The authors would also like to acknowledge Peter V Killoran, MD, for his assistance obtaining electronic data and Michelle Sauer, PhD, ELS, for her editorial contributions.

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    Disclosure Information: Dr Albarado receives speaker payments from Mallinckrodt Pharmaceuticals Speakers Bureau (Ofirmev).

    Disclosures outside the scope of this work: Dr Holcomb is a paid consultant to PotentiaMetrics, Inc, Arsenal Medical, Inc, Cellphire, Inc, and CSL Limited; is a paid advisor to Spectrum Medical and Safeguard Medical, LLC; receives equity as a member of the Board of Directors for Decisio Health, QinFlow, and ZIBRIO; and receives royalty payments from UT Health as co-inventor of the Junctional Emergency Tourniquet Tool. Other authors have nothing to disclose.

    Support: Dr Harvin was supported by the Center for Clinical and Translational Sciences, which is funded by NIH Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences.

    Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the NIH. This trial was also supported by a Learning Healthcare Award from the McGovern Medical School at University of Texas Health.

    Members of the MAST Study Group who coauthored this article are listed in the Appendix.

    Trial registration: ClinicalTrials.gov ID NCT03472469.

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