Phase 3
N=49
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
ACL Injury · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT04246554 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Postoperative Visual Analogue Scale Scores — 50.4; 40.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketorolac (Drug); Oxycodone-Acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Visual Analogue Scale Scores |
50.4; 40.0 | — |
| SECONDARY Narcotic Medication |
12.4; 5.5 | — |
Summary
1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery.
2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.
Eligibility Criteria
Inclusion Criteria
- Patients between 18 and 89 years old
- Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery
Exclusion Criteria
- Patients below age 18 or above age 89
- Illiterate or non-English speaking individuals
- Patients with contraindications to Ketorolac
- History of chronic alcohol or drug abuse
- Chronic use of psychotropic or analgesic drugs
- Known peptic ulcer disease or bleeding diasthesis
- Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
- Breastfeeding women
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT04246554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.