Grants and Contracts Details
Background: Post-traumatic pain (PTP) can be difficult to control in polytrauma patients. Currently, opioids serve as the cornerstone for pain management despite their potential for complications including chronic use. Given this, it is not surprising that new onset opioid abuse is a leading cause of complications following polytrauma and can be a limiting factor in safely resuming pre-injury responsibilities. Changes in pain- management are needed to help military personnel and civilians return to their pre-injury duty and lives. It remains unknown whether ketorolac can improve functionality and resilience while reducing chronic opioid use and what factors lead patients to chronic opioid use. Hypothesis/Objective: The present study will test the primary hypothesis that scheduled inpatient intravenous (IV) ketorolac in polytrauma patients improves functionality and resilience with enhanced pain control. This study will also test the secondary hypotheses that IV ketorolac will decrease long-term opioid use. Finally, the study will evaluate how these factors lead to chronic opioid use. Specific Aims: Aim 1: Determine if patients receiving the ketorolac intervention compared to the placebo group have (1) decreased pain measured using the visual analogue scale (VAS) at the completion of the intervention and at discharge as well as opioid consumption during the intervention measured using morphine milligram equivalents (MME) and (2) an improved functional response to pain measured using the Brief Pain Inventory (BPI), the Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS- PI), and the Brief Resilience Scale (BRS) at discharge and 3- and 6-months post-injury. Aim 2: Determine whether orthopaedic polytrauma patients who receive IV ketorolac, 15 mg every six hours, in combination with standard of care (SOC) analgesia for the first five inpatient days are less likely to develop chronic opioid use, continued use of opioids at six months post-injury, compared to patients receiving similar placebo injections in combination with SOC. Aim 3: Determine (1) the extent to which early pain control during the intervention, assessed using pain VAS and MME intake, mediates the effect of ketorolac on chronic opioid use, (2) the extent to which early pain control mediates the effect of ketorolac on the functional response to pain measures, assessed using BPI, PROMIS-PI, and BRS, and (3) the extent to which early pain control and the functional response to pain in combination or isolation mediate the effect of ketorolac on chronic opioid use. Study Design: Polytrauma patients aged 18 to 70 years of age with a New Injury Severity Score greater than 9, consistent with moderate injury, and anticipated admission of at least 5 days to ensure completion of the treatment will be enrolled. Experienced clinical research staff will prospectively identify patients with strict adherence to all inclusion and exclusion criteria. Participants will be randomized to treatment (15 mg of ketorolac every 6 hours for 5 days) or control (similar volume of saline every 6 hours for 5 days). Measures of the psychological response to pain including the BPI, PROMIS-PI, and BRS will be collected at hospital discharge and 3- and 6-months post-injury. Outcome measures of pain including VAS and MME will be recorded at enrollment, during the first five days of inpatient admission, at discharge, and at clinic follow-ups. The treatment and control groups will be compared using the intention-to-treat analyses across the primary and secondary outcomes. A series of mediation analyses will be used to understand how early pain control and the functional response to pain mediate the effect or lack of effect on chronic opioid use. Impact and Military Benefit: Military personnel are at high risk for extremity battle wounds that cause PTP. This unfortunately places these men and women at high risk of chronic opioid use which can limit their return to duty. Elucidating pain management practices that can increase return to duty and reduce chronic opioid use is of utmost importance. This research has the potential to impact military health by not only identifying a specific treatment to reduce chronic opioid use in this population but also by improving our basic understanding of what factors are responsible for some patients developing chronic opioid use. This work will have a direct effect and potential benefit on military health, readiness, and resilience.
|Effective start/end date||9/1/23 → 11/1/23|
- Army Medical Research and Materiel Command: $2,499,963.00
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