Low-Dose Ketorolac for Multiple Trauma

Recruiting at 1 trial location

Overseen By Adam N Musick, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must not be taking: Steroids, Immune-modulating drugs, Opioids, NSAIDs

Disqualifiers: Pregnancy, Renal disease, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 5 days

458 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Does scheduled ketorolac during the first five hospital days 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 placebo group to be given every 6 hours during the first five hospital days. 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 ketorolac (treatment) versus saline (placebo) to see if ketorolac reduces chronic opioid use and improves the functional response to pain.

Research Team

Arun Aneja, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for orthopaedic polytrauma patients with multiple injuries who may be at risk of developing chronic opioid use. Participants must not have conditions that prevent NSAID use, such as certain bleeding disorders, kidney failure, or known allergies to ketorolac.

Inclusion Criteria

I had a severe injury needing surgery.

Patients who can be followed at our facility for at least 6 months

I expect to be in the hospital for 5 days or more.

Exclusion Criteria

My injury occurred over 24 hours ago.

I am at risk of severe bleeding or have experienced hemorrhagic shock.

I have had a heart attack, stroke, or a bleeding disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 15 mg of intravenous ketorolac or placebo every 6 hours during the first five hospital days, in addition to standard of care multimodal analgesia

5 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for opioid use and functional response to pain at discharge, 2 weeks, 6 weeks, 3 months, and 6 months post-injury

6 months

Visits at discharge, 2 weeks, 6 weeks, 3 months, and 6 months

Long-term Follow-up

Participants' chronic opioid use is assessed at 6 months post-injury

6 months

Treatment Details

Interventions

• Ketorolac

Trial Overview The study tests if low-dose ketorolac injections can reduce long-term opioid dependency compared to a saline placebo in trauma patients. It measures pain and opioid consumption over five days and follows up on pain function and opioid use up to six months post-injury.

Participant Groups

Group I: Standard of Care (SOC) + Ketorolac Experimental Treatment 1 Intervention

The treatment arm will receive 15 mg of intravenous (IV) ketorolac every 6 hours during the first five hospital days, in addition to standard of care (SOC) multimodal analgesia according to each site's institutional protocol.

Group II: Standard of Care (SOC) Placebo Group 1 Intervention

The placebo arm will receive 2 mL of intravenous (IV) saline every 6 hours during the first five hospital days, in addition to standard of care (SOC) multimodal analgesia according to each site's institutional protocol.

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea
• Idiopathic pericarditis
• Ocular itching

Approved in European Union as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea

Approved in United States as Acular for:

• Ocular itching
• Inflammation after eye surgery

Approved in United States as Sprix for:

• Moderate to severe pain

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+