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Can a Five-Day NSAID course curb opioid dependence after severe bone injuries?

NCT ID NCT06201676

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 4 trial tests whether giving the NSAID ketorolac (Toradol) for the first five days after orthopedic trauma surgery can reduce the chance of patients still needing opioids six months later. About 458 adults aged 18–70 with acute musculoskeletal injuries requiring surgery will be randomly assigned to receive either ketorolac plus standard pain management or standard care alone. Researchers will track opioid use and pain-related function over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketorolac (Toradol)
What this could lead to
If it works, this could provide a simple, low-cost way to reduce the risk of chronic opioid dependence after serious orthopedic injuries.
What could go wrong
This is a single trial with 458 participants, and the effect may be modest or not apply to all patients. Ketorolac can cause side effects like stomach bleeding or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 458 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

injury opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic opioid use Orthopaedic polytrauma Orthopaedic trauma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.