Recruiting

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

Sponsor:

Massachusetts General Hospital

Code:

NCT06201676

Conditions

Orthopaedic Trauma

Chronic Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Ketorolac Injection

Standard of Care (SOC) Multimodal Analgesia

Study Details

Brief summary:

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 trauma patients. The main questions this study aims to answer are:

1. Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone?
2. Does scheduled ketorolac during the first five days of the perioperative period improve functional responses to pain at discharge, 3 months, and 6 months after injury?
3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?

Participants will be enrolled and randomized to either the ketorolac (treatment) group or the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.

Researchers will compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.

Conditions

Orthopaedic Trauma

Chronic Opioid Use

Study ID

NCT06201676

Start date

Feb 28, 2025

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

458 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard of Care (SOC) + Ketorolac

The treatment arm will receive a scheduled five-day course of low-dose ketorolac in addition to standard of care (SOC) multimodal analgesia according to each site's institutional protocol. Ketorolac will be administered intravenously at a dose of 15 mg every 6 hours during the perioperative period. Participants discharged prior to completing the five-day regimen will complete the remaining treatment with oral ketorolac 10 mg every 8 hours.

active comparator: Standard of Care (SOC)

The control arm will receive standard of care (SOC) multimodal analgesia according to each site's institutional protocol.

Interventions

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.

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 measure

Chronic Opioid Use [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Arun Aneja, MD, PhD

617-726-6546 aaneja@mgh.harvard.edu

Healy S. Vise, BS

617-643-1232 hvise@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Arun Aneja, MD, PhD

aaneja@mgh.harvard.edu

Healy Vise, BS

hvise@mgh.harvard.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

William Obremskey, MD

william.obremskey@vumc.org

Karen M Trochez

karen.m.trochez@vumc.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

orthopaedic trauma
chronic opioid use
NSAID
IV ketorolac
acute pain management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-14.