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

Conditions

• Chronic Opioid Use
• Orthopaedic Trauma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Ketorolac Injection — DRUG
  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 — OTHER
  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.

Study Details

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.

Key Dates

Start date

Feb 28, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Aug 31, 2027

Study Design

Enrollment

458 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Chronic Opioid Use [ Time Frame: 6 months ]

Central Contacts

• Arun Aneja, MD, PhD
  617-726-6546
  [email protected]
• Healy S. Vise, BS
  617-643-1232
  [email protected]

Locations (2)

Find similar trials in Boston, MA

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