Using low-dose ketorolac to reduce opioid use in patients with multiple orthopedic injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.