Article Text
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.
- trauma/ critical care
- injury
- acute pain
- Opioid
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Footnotes
Contributors Conception and design: JAH, CG, LEV, KLM, JP, CCM, JET, JBH, CEW, and LSK. Drafting of the article: JAH, CG, and LEV. Critical review of the article: LEV, KLM, JP, CCM, JET, JBH, CEW, and LSK.
Funding JAH is supported by the Center for Clinical and Translational Sciences, which is funded by the National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. 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 National Institutes of Health.
Competing interests None declared.
Patient consent Not required.
Ethics approval UT Health Committee for the Protection of Human Subjects.
Provenance and peer review Not commissioned; externally peer reviewed.