Actively Recruiting
Non-Narcotic Pain Control After ACL Reconstruction A Double-Blind Randomized Controlled Trial Comparing Oral Ketorolac and Oxycodone
Led by The Cleveland Clinic · Updated on 2025-08-11
30
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of oral ketorolac versus oral oxycodone for pain control after primary knee anterior cruciate ligament (ACL) reconstruction surgery. This randomized, double-blind trial aims to show if ketorolac can reduce the use of narcotics compared to standard treatment with oxycodone. The study focuses on the percentage of narcotic doses taken and the number of patients who avoid any narcotics after surgery. Participants will be randomly assigned to one of two groups. One group receives ketorolac (10 mg) tablets with oxycodone (5 mg) as rescue medication, while the other group receives oxycodone (5 mg) tablets with diclofenac as rescue medication. Both groups will also take acetaminophen for the first 72 hours after surgery. Medications are provided in identical capsules and sealed blister packs to keep patients and staff unaware of group assignments. The treatment period focuses on the first 72 hours post-operation. Participants will take study medications as directed and attend virtual follow-ups at 1 and 2 weeks for pill counts. Researchers will monitor medication use, pain control, and safety during this period. The primary outcome is the reduction in narcotic pill use within the first 72 hours after surgery. The total participation time includes medication use and follow-up assessments to assess pain control and medication adherence.
CONDITIONS
Brief Title
Non-Narcotic Pain Control After ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 15 to 55 years
- Scheduled for primary autograft ACL surgery
- Ability to take oral medication and willingness to participate in virtual 1 and 2 week follow-up pill counts
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 72 hours postoperatively
Participants receive either oral ketorolac or oxycodone after ACL reconstruction as part of a multimodal pain control approach including acetaminophen for the first 72 hours post-surgery.
Medication dispensed postoperatively in sealed blister packets
Duration - Up to 30 days
Participants complete virtual follow-up visits for pill counts and assessment of pain control.
1 virtual visit at 1 week and 1 virtual visit at 2 weeks
Trial Site Locations
Total: 3 locations
1
Cleveland Clinic Coral Springs
Coral Springs, Florida, United States, 33067
Active, Not Recruiting
2
Cleveland clinic sports medicine
Garfield, Ohio, United States, 44125
Actively Recruiting
3
Cleveland Clinic
Strongsville, Ohio, United States, 44136
Actively Recruiting
Research Team
J
Jennifer Baldwin
N
Nick Niehart
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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