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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ketorolac, a non-narcotic medication, can effectively manage pain after ACL knee surgery, potentially reducing the need for opioids like oxycodone. Researchers aim to determine if ketorolac allows patients to experience less pain and require fewer narcotic doses. The trial involves two groups: one receiving ketorolac and the other receiving oxycodone. Individuals who have undergone ACL reconstruction surgery and can take oral medication might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important research on pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketorolac is generally well-tolerated for managing post-surgical pain. In studies, participants who took ketorolac reported less pain than those who did not. The two groups showed no significant difference in side effects, suggesting that ketorolac is safe for most patients to reduce post-surgical pain.

Since this trial is in a later phase, ketorolac has already demonstrated safety in earlier stages, making serious side effects unlikely. However, as with any treatment, risks exist, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ketorolac for ACL injuries because it offers a non-narcotic alternative to pain management. Unlike standard treatments like oxycodone, which is a narcotic and can lead to dependency issues, ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that works by reducing inflammation and pain without the risk of addiction. This makes it a safer option for patients looking for effective pain relief without the potential for opioid-related side effects.

What evidence suggests that ketorolac might be an effective treatment for ACL injury?

Research has shown that ketorolac can significantly reduce pain after surgery. In one study, patients who took ketorolac reported pain levels 22.36 points lower than those who did not take it, indicating its effectiveness in managing pain after ACL surgery. However, another study found that ketorolac did not work for 34% of patients, suggesting it helped most people. In this trial, participants will receive either ketorolac or oxycodone, a narcotic, to compare their effectiveness. Overall, ketorolac has shown promise in reducing the need for stronger painkillers like narcotics after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Kurt P Spindler, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36476466/

Oral Ketorolac as an Adjuvant Agent for Postoperative Pain ... In addition, mean postoperative pain scores were 22.36 points lower for patients in the ketorolac group (P < 0.001). There was no difference in ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/2325967114529537

The Effect of Perioperative Ketorolac on the Clinical Failure ... There was an overall failure rate of 35% (37/107 patients), with a 34% failure rate in patients receiving ketorolac (11/32 patients).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806321000372

Meta-analyses Pain Management Strategies After Anterior ... Intra-articular injections consisting of bupivacaine and an adjunct were found to reduce reported postoperative pain scores up to 12 hours after ACLR, with ...

4. iasp-pain.org iasp-pain.org/oral-ketorolac-as-an-adjuvant-agent-for-postoperative-pain-control-after-arthroscopic-anterior-cruciate-ligament-reconstruction-a-prospective-randomized-controlled-study/

Oral Ketorolac as an Adjuvant Agent for Postoperative Pain ... Successful outpatient anterior cruciate ligament (ACL) reconstruction hinges on effective analgesia. Routinely, oral narcotic agents have ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18661874/

The effect of ketorolac on anteroposterior knee laxity after ... This study investigated the effect of ketorolac on anteroposterior laxity after anterior cruciate ligament (ACL) reconstruction. A total of 168 ACL ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04246554

Ketorolac as an Adjuvant Agent for Postoperative Pain ... The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X21001723

a Survey of Pre- and Postoperative Pain Protocols for ... The incidence of anterior cruciate ligament (ACL) injuries in pediatric (aged ≤17 years) patients has been reported to increase at an average annual rate ...

8. withpower.com withpower.com/trial/ketorolac-for-acl-injury-a98ca

Ketorolac for ACL Injury This Phase 3 medical study run by The Cleveland Clinic is evaluating whether Ketorolac will have tolerable side effects & efficacy for patients with ...