Recruiting

Ketorolac

Sponsor:

Henry Ford Health System

Code:

NCT07037888

Conditions

Femoracetabular Impingement

Hip Arthroscopy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Control (Standard treatment)

Control (Standard treatment)

Control (Standard treatment)

Omeprazole

Study Details

Brief summary:

The goal of this clinical trial is to learn whether the medication ketorolac can help manage pain after hip arthroscopy as well or better than the standard opioid-based pain medications. This study focuses on adult patients (over 18 years old) undergoing hip arthroscopy at Henry Ford Health System in Detroit, Michigan. Both men and women are included, and all participants must be able to consent and communicate in English.

The main questions it aims to answer are:

Can ketorolac help control pain as effectively or better than opioids after hip arthroscopy?

Will ketorolac use reduce the amount of opioid medication needed after surgery?

Researchers will compare the group receiving ketorolac to the group receiving standard opioid pain medications to see if ketorolac reduces pain and opioid use after surgery.

Participants will:

Be randomly assigned to one of two groups:

The control group, which receives the current standard pain management protocol (hydrocodone-acetaminophen and diazepam)

The experimental group, which receives the same protocol plus ketorolac and a stomach-protecting medication (omeprazole)

Receive their assigned pain medications after hip arthroscopy

Be asked to:

Take the prescribed medications after discharge

Complete a pain journal for 5 days following surgery, documenting pain levels and any side effects

Complete follow-up surveys and assessments at 2 weeks, 6 weeks, and 3 months after surgery

The main measurement researchers will use is the Visual Analog Scale (VAS) for pain on post-operative day 4. Additional measures include how many narcotic pills are used and results from PROMIS physical function and pain interference scores.

The hope is that ketorolac will provide equal or better pain control without the risks of addiction and side effects associated with opioid medications. If successful, this approach could offer a safer alternative for managing pain after hip arthroscopy. Participants may personally benefit by having effective pain relief with fewer risks, and future patients could benefit from improved pain management options.

Conditions

Femoracetabular Impingement

Hip Arthroscopy

Study ID

NCT07037888

Start date

Dec 13, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing hip arthroscopy over the age of 18 with Dr. T. Sean Lynch
  • Diagnosis of femoroacetabular impingement (FAI)

Exclusion Criteria:

  • Patients with inability to consent and/or do not speak English
  • Patients with conditions contraindicated with NSAIDs (medication allergy, peptic ulcer disease, bleeding diathesis, and renal disease)
  • Patients with history of drug and alcohol use disorder
  • Patients with chronic analgesia (filled two opioid prescriptions within 6 months of the surgery)
  • Patients with psychotropic medication usage
  • Patients who take pentoxifylline, probonecid, aspirin, and/or NSAIDs who cannot stop taking it for the study
  • Patients who are not discharged same day after surgery

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Control

The standard of care/control pain protocol

active comparator: Ketorolac

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

Interventions

Ketorolac

IV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0

Control (Standard treatment)

hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets

Control (Standard treatment)

indomethacin 75mg 1 tablet QD to start on POD0 10 tablets

Control (Standard treatment)

diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets

Omeprazole

20 mg qd

Primary outcome measure

  • Visual Analogue Scale (VAS) [ Time Frame: 5 days ]

Central Contacts and Locations

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Thomas Lynch

More Information

Sponsor

Henry Ford Health System

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Sports Medicine
  • Hip Arthroscopy
  • FAI
  • Opioids
  • Ketorolac
  • Multi-modal pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-06-30.