NCT04246541

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meniscus Tear, Tibial
• Pain, Postoperative
• Postoperative Complications
• Ketorolac Adverse Reaction
• Opioid Use

Interventions

Type	Name	Description
DRUG	Ketorolac	Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
DRUG	Oxycodone-Acetaminophen	Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.

Timeline

• Start date: 2019-04-23
• Primary completion: 2021-09-12
• Completion: 2021-09-12
• First posted: 2020-01-29
• Last updated: 2022-03-03
• Results posted: 2021-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study