Using low-dose ketorolac to reduce opioid use in patients with multiple orthopedic injuries
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
This study is testing if giving low-dose ketorolac to patients with multiple orthopedic injuries can help manage their pain and reduce the need for long-term opioid use.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 458 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06201676 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering low-dose ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), during the first five days of hospitalization can reduce the likelihood of chronic opioid use in patients with orthopedic polytrauma. Participants will be randomly assigned to receive either ketorolac or a placebo, with pain and opioid use monitored daily. The study aims to determine the effectiveness of ketorolac in improving pain management and functional outcomes, as well as its potential to decrease long-term opioid dependence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with significant musculoskeletal trauma requiring surgical intervention and an anticipated hospital stay of at least five days.
Not a fit: Patients who are under 18 or over 70 years old, or those with certain medical conditions such as active gastrointestinal issues or chronic organ diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic opioid use and improve pain management in orthopedic polytrauma patients.
How similar studies have performed: Previous studies have shown that short-term ketorolac treatment can effectively reduce acute pain and opioid use, suggesting potential success for this approach in preventing chronic opioid use.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age: 18-70 * Patient or legally authorized representative (LAR) able to provide consent * Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and/or intramedullary nailing) * Anticipated hospital admission * Patients who speak English or Spanish * Patients who can be followed at the enrolling facility for at least 6 months Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Arun Aneja, MD, PhD — Massachusetts General Hospital
- Study coordinator: Arun Aneja, MD, PhD
- Email: aaneja@mgh.harvard.edu
- Phone: 617-726-6546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.