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Ketorolac to Reduce Chronic Opioid Use After Orthopaedic Trauma

This study is looking into whether a short course of a pain medication called ketorolac can help reduce the need for long-term opioid pain relievers in patients who have had orthopaedic (bone and joint) trauma. Researchers want to see if giving ketorolac for the first five days after surgery, along with standard pain care, makes patients less likely to use opioids chronically six months later. They also want to know if ketorolac improves how well patients manage their pain and function. This study is for people aged 18 to 70 who have had acute musculoskeletal trauma requiring surgery and can speak English or Spanish. The study is currently unclear about its recruitment status and plans to enroll 458 participants.

Study design
This is a randomized clinical trial, meaning participants will be assigned by chance to receive either ketorolac plus standard care or standard care alone. The study aims to enroll 458 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least six months after their injury to assess chronic opioid use and functional responses to pain.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06201676

Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients

Recruiting
PHASE4Ages 18–70InterventionalTreatment
Massachusetts General Hospital
~458 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Ketorolac InjectionStandard of Care (SOC) Multimodal Analgesia

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Chronic Opioid Use
Measured over 6 months

Conditions

Orthopaedic Trauma
Chronic Opioid Use

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Orthopaedic Trauma

NCT06201676

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Arun Aneja, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Arun Aneja, MD, PhD
[email protected]
617-726-6546
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Chronic Opioid Use6 months

    Defined as continued opioid use at 6 months post-trauma