Phase 3
N=48
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Meniscus Tear, Tibial · Pain, Postoperative · Postoperative Complications · Ketorolac Adverse Reaction · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04246541 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Pain Levels Recorded With a Visual Analogue Scale — 25.6; 28.8 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
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Levels Recorded With a Visual Analogue Scale |
25.6; 28.8 | — |
| PRIMARY Narcotic Medication Consumed |
5.7; 3.5 | — |
Summary
The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.
Eligibility Criteria
Inclusion Criteria
- Patients between 18 and 89 years of age
- Patients undergoing primary arthroscopic meniscus surgery
Exclusion Criteria
- Patients age less than 18 or greater than 89 years
- Illiterate or non-English speaking patients
- Patients with contraindications to ketorolac
- History of drug or alcohol abuse
- Chronic use of analgesic or psychotropic drugs
Data sourced from ClinicalTrials.gov (NCT04246541). 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.