CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 48 enrolled
Drug / intervention
Ketorolac +1 moredrug
Likely dose
Ketorolac 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04246541
NCT04246541Phase 3Completed

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

University Hospitals Cleveland Medical Center·interventional·Posted Jan 29, 2020·Updated Mar 3, 2022

In Brief

A Phase 3 clinical trial evaluating Ketorolac and Oxycodone-Acetaminophen for Meniscus Tear, Tibial and 4 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 29, 2020
Enrollment StartApr 23, 2019
Primary CompletionSep 12, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.4 years ago

Interventions

Ketorolacdrug

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.

Oxycodone-Acetaminophendrug

Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.