RecruitingPhase 4NCT06201676

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

Sponsor

Massachusetts General Hospital

Enrollment

458 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Orthopaedic trauma Chronic Opioid Use

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria15

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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Interventions

DRUGKetorolac 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.

OTHERStandard 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.