NCT06201676 · Massachusetts General Hospital
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
What this study is about
The goal of this randomly assigned 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 patients. The main questions this study aims to answer are: 1.
View original scientific description
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 patients. The main questions this study aims to answer are: 1. Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo? 2.
Interventions
DRUG
Ketorolac Injection
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin Reference ID: 3281582 3 synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form. Ketorolac tromethamine possesses no sedative or anxiolytic properties.
OTHER
Standard of Care (SOC) Multimodal Analgesia
Standard of care (SOC) multimodal analgesia as determined by each participating site's institutional protocol for perioperative pain management in orthopaedic trauma patients. SOC may include opioids, acetaminophen, regional anesthesia, and other non-NSAID analgesic modalities. Scheduled nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, are not permitted during the five-day perioperative treatment period.
Primary outcome measures
Chronic Opioid Use
Time frame: 6 months
Defined as continued opioid use at 6 months post-trauma
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
- Nashville, Tennessee
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations