Status:
RECRUITING
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
United States Department of Defense
Conditions:
Orthopaedic Polytrauma
Chronic Opioid Use
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic polytrauma...
Detailed Description
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 incl...
Eligibility Criteria
Inclusion
- Patient age: 18-70
- Patient or legally authorized representative (LAR) able to provide consent
- Patients with NISS ≥ 9 at time of admission with musculoskeletal trauma requiring surgical fixation
- Anticipated admission ≥ 5 days
- Patients who speak English or Spanish
- Patients who can be followed at the enrolling facility for at least 6 months
Exclusion
- Patient age \< 18 or \> 70 years
- Patients with injury more than 24 hours prior to evaluation
- Patients with active hemorrhagic shock or risk of significant hemorrhage
- Patients who are pregnant or breastfeeding
- Patients with a history of active gastrointestinal bleeds or ulceration
- Patients with chronic use of steroids or immune-modulating drugs or history of organ transplantation
- Patients with preexisting chronic renal, liver, heart, or lung disease
- Patients with a creatinine ≥ 1.30 mg/dL during enrollment
- Patients with history of myocardial infarction, stroke, or bleeding disorder
- Patients with head or chest injury requiring surgical intervention
- Patients with allergy to ketorolac or hypersensitivity to aspirin
- Patients receiving chronic opioid therapy or treatment for opioid use disorder
- Patients who are current IV drug users
- Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)
- Patients with insufficient follow-up or anticipated difficulty in completing follow-up at a study site for a minimum of 6 months due to any of the follow reasons: death, no follow-up after initial discharge, severe psychiatric conditions, unstable living conditions, planned follow-up at another medical center not participating in this study, live far away from the clinic, and/or incarcerated
Key Trial Info
Start Date :
February 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT06201676
Start Date
February 28 2025
End Date
August 31 2027
Last Update
October 7 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232