A Phase 4 interventional study of Ketorolac and Control (Standard treatment) in Femoracetabular Impingement and Hip Arthroscopy, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Other
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.
108 studies on the registry are indexed under Femoracetabular Impingement; 35 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 63 interventional studies indexed under Femoracetabular Impingement.
Browse Femoracetabular Impingement studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The standard of care/control pain protocol
Drug: Control (Standard treatment)
Intra-operative IV and Oral doses of Ketorolac plus Standard of care
Drug: Ketorolac · Drug: Control (Standard treatment) · Drug: Omeprazole
IV ketorolac intraoperative loading dose Ketorolac 10mg 1 tablet q6hrs to start on POD0
hydrocodone-acetaminophen 5mg/325mg 1 tablet q6hrs PRN to start on POD0 30 tablets
indomethacin 75mg 1 tablet QD to start on POD0 10 tablets
diazepam 5mg 1-2 tablets q8hrs PRN to start on POD0 15 tablets
20 mg qd
Visual Analogue Scale (VAS)
A validated tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with the far-left end meaning no pain and the far-right end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine.
Time frame: 5 days
PROMOIS- PF
This is a standardized patient-reported outcome measure that assesses an individual's self-reported capability to perform physical activities, including both basic activities of daily living (ADLs) and instrumental activities of daily living (IADLs). It utilizes a T-score scale, mean = 50, standard deviation = 10, and higher scores indicate greater physical function.
Time frame: 2 weeks, 6 weeks, 3 months
PROMOIS- PI
a patient-reported outcome measure that assesses the extent to which pain hinders a person's engagement in various activities. It utilizes a T-score scale, mean = 50, standard deviation = 10, and higher scores indicate greater interference from pain.
Time frame: 2 weeks, 6 weeks, 3 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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