A Phase 2 interventional study of dispense of study drug and Ketorolac in ACL - Anterior Cruciate Ligament Rupture and ACL Injuries, sponsored by The Cleveland Clinic. Active, not recruiting at 3 sites in United States. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by The Cleveland Clinic · Phase 2, Interventional, and Treatment
This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.
This is a multi-center, 2 arm, randomized 1:1 controlled trial, with a blinded patient and outcome assessment study. Narcotics are currently the standard of care as part multimodal pain control in major joint surgery including ACLR. Twelve (12) ketorolac (10mg) and twelve (12) oxycodone (5mg) tablets will be shrouded in identical capsules for the pain packet designed for blinding. The capsules will be dispensed in sealed single-pill release blister packets. The enrolled patients will be randomized by the surgeon. The surgeon, clinical team, and patient will be blinded as to treatment (double-blind study). The rescue medication will be specific to each treatment group, encapsulated for blinding, and in a packet labeled RESCUE medication. For the experimental group (ketorolac) they will have 9 oxycodone as rescue medication. For the control group (oxycodone) they will have 9 diclofenac as rescue medication. Both groups will also be given acetaminophen for the first 72 hours. All medications in our multimodal approach will be provided postoperatively after ACL reconstruction to both groups. The primary endpoint will be the percentage reduction in narcotics pills per patient in each group in first 72 hours postoperatively verified from sealed packages.
512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
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Exclusion Criteria:
1. Any extensor mechanism dislocation or disruption 2. Multi-ligament injury that requires repair 3. Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control 4. Psychiatric illness that impedes evaluation of pain and/or narcotics use 5. History of Chronic Kidney Disease 6. History of inflammatory arthritis, diabetes, or autoimmune disease 7. History of GI bleed or documented GI ulcer (diagnosed by endoscopy) 8. Allograft or revision of ACLR 9. Contraindications to ketorolac or opioids
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Arm 1
Drug: Ketorolac
Arm 2
Drug: dispense of study drug
• Cohort Group 1 (Experimental): ketorolac 10mg with rescue medication oxycodone 5mg All patients will be given acetaminophen
Also known as: oxycontin
Patients will be randomized to either Ketorolac or Oxycodone
Also known as: Toradol
Primary outcome
How many narcotic pills were consumed
Time frame: 30 days
Plan to share: Yes — Only IPD will be used in the results publications
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries→
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