Ketorolac for ACL Injury

Recruiting at 2 trial locations

Overseen By Jennifer Baldwin

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: The Cleveland Clinic

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.

Research Team

Kurt P Spindler, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for individuals who have had an ACL reconstruction surgery and are looking to manage pain without narcotics. Participants should be suitable for outpatient surgery but cannot join if they have specific conditions that the study hasn't listed.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

Provision of signed and dated informed consent form

I am between 15 and 55 years old.

Exclusion Criteria

I can take pills and am willing to do virtual pill counts.

Provision of signed and dated informed consent form

I am between 15 and 55 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral ketorolac or oral oxycodone postoperatively after ACL reconstruction

72 hours

Postoperative care

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on narcotic consumption

30 days

Treatment Details

Interventions

• Ketorolac

Trial Overview The study is testing the effectiveness of oral ketorolac, a non-narcotic medication, against oral oxycodone, a narcotic drug. It's designed to see if ketorolac can reduce or eliminate the need for narcotics after ACL surgery.

Participant Groups

Group I: Oxycodone- Narcotic Active Control 1 Intervention

Arm 1

Group II: Ketorolac Placebo Group 1 Intervention

Arm 2

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+