Ketorolac for Postoperative Pain

(Keto Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Henry Ford Health System

Must not be taking: Psychotropics, Aspirin, NSAIDs, others

Disqualifiers: Drug/alcohol disorder, Chronic analgesia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 5 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), can manage pain after hip arthroscopy as effectively as or better than opioids, which are commonly used but carry risks like addiction. Researchers will compare pain levels and opioid usage between two groups: one receiving standard opioid treatment and the other receiving ketorolac in addition to standard care. The trial aims to determine if ketorolac can provide effective pain relief with fewer downsides. Suitable participants are adults undergoing hip arthroscopy specifically for femoroacetabular impingement (a hip condition) and who can discontinue certain medications during the study. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how ketorolac benefits more patients, offering a chance to contribute to valuable insights.

Will I have to stop taking my current medications?

If you take pentoxifylline, probenecid, aspirin, or NSAIDs, you will need to stop taking them for this study. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

What is the safety track record for ketorolac?

Research has shown that ketorolac is generally safe for managing pain after surgery. Studies have found it provides effective pain relief, especially in the first few hours post-surgery, without significantly increasing common side effects. One study found that patients using ketorolac experienced similar rates of both major and minor complications compared to those not using it.

Additionally, ketorolac may help reduce the need for opioids, which can be addictive and have serious side effects. No evidence suggests that ketorolac increases risks like blood clots or other physical problems.

Overall, ketorolac offers effective pain relief with a safety profile similar to other treatments, making it a promising option for managing pain after surgeries like hip arthroscopy. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard postoperative pain management options, which often rely on opioids or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, Ketorolac is unique because it is a powerful NSAID that can be administered both intravenously and orally. This dual delivery method allows for flexible dosing and potentially faster pain relief right after surgery. Researchers are excited about Ketorolac because it offers a strong pain-relieving effect without the dependency risks associated with opioids, making it a promising option for safer postoperative pain management.

What is the effectiveness track record for ketorolac in managing postoperative pain after hip arthroscopy?

Research has shown that ketorolac, which participants in this trial may receive, can effectively reduce post-surgical pain. One study found that ketorolac not only eases pain but also reduces the need for opioids (strong painkillers) after operations like back surgery. Another study suggested that a single dose of ketorolac can cut short-term pain by 50% or more compared to a placebo (a fake treatment). Ketorolac has proven more effective than some other pain treatments in reducing the need for opioids. These findings support ketorolac as a promising option for managing pain after surgeries. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 who are undergoing hip arthroscopy at Henry Ford Health System and can consent/communicate in English. They should not have conditions that exclude them from the study, which aren't specified here.

Inclusion Criteria

I am over 18 and having hip arthroscopy with Dr. T. Sean Lynch.

I have been diagnosed with FAI.

Exclusion Criteria

Patients with inability to consent and/or do not speak English

I cannot stop taking my current medications for the study.

Patients with history of drug and alcohol use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive their assigned pain medications after hip arthroscopy, including either the standard protocol or the protocol with ketorolac

5 days

In-patient stay for surgery and initial recovery

Follow-up

Participants complete follow-up surveys and assessments to monitor pain levels and medication use

3 months

Follow-up visits at 2 weeks, 6 weeks, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac

Trial Overview The trial is testing if ketorolac combined with omeprazole is as effective or better than standard opioid pain meds for managing postoperative pain after hip surgery. Participants will be randomly assigned to either the control group with standard treatment or the experimental group receiving ketorolac.

How Is the Trial Designed?

Group I: Ketorolac Active Control 3 Interventions

Intra-operative IV and Oral doses of Ketorolac plus Standard of care

Group II: Control Placebo Group 1 Intervention

The standard of care/control pain protocol

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11536961/

The efficacy and safety of ketorolac for postoperative pain ... The findings suggest that Ketorolac effectively reduces pain and opioid use postoperatively, supporting its role in multimodal analgesia for lumbar spinal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07037888

Study Details | NCT07037888 | Efficacy of Ketorolac for ... The goal of this clinical trial is to learn whether the medication ketorolac can help manage pain after hip arthroscopy as well or better ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03335-0

Comparing the efficacy of combining ketorolac and ... Comparing ketorolac with ibuprofen for postoperative pain: a randomized clinical trial. Urogynecology. 2020;26(4):233–8. Google Scholar.

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013263.pub2/full

Single‐dose intravenous ketorolac for acute postoperative ... Ketorolac may reduce short‐term pain after surgery by 50% (half) or more in more people than a placebo (dummy treatment). · There may be little ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590139725000729

A randomized trial comparing the effects of single-dose ... In conclusion, ketorolac proves to be more effective than dexamethasone in reducing morphine consumption 48 h after surgery. However, both drugs were found to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39501393/

The efficacy and safety of ketorolac for postoperative pain ... No significant increase in common adverse effects was noted, indicating Ketorolac's safety profile. Conclusion: Ketorolac administration, either ...

7. journals.lww.com journals.lww.com/spinejournal/abstract/9900/postoperative_ketorolac_administration_and.1100.aspx

Postoperative Ketorolac Administration and ... Postoperative ketorolac may reduce short-term opioid use and thromboembolic risk without increasing pseudoarthrosis or mechanical complications.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024000548

The Impact of Ketorolac Utilization on Outcomes for ... Overall, patients had similar rates of major complications (3.7% vs. 5.4%) and minor complications (42.1% vs. 51.7%) between groups after lumbar surgery.

9. tandfonline.com tandfonline.com/doi/full/10.1080/17581869.2025.2560293?src=exp-la

Efficacy and adverse effects of lower doses of ketorolac In acute, postoperative, and cancer pain, there was no difference in the analgesic effect of lower doses of ketorolac in comparison to routine doses. In ...