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NCT04246541 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.

Completed
Registry status
Phase 3
Development phase
48
Enrollment target

NCT04246541: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.

NCT04246541 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04246541, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
48 participants
Enrollment target

Study 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.

Primary Outcome

Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level.

Interventions

  • DRUG Ketorolac
  • DRUG Oxycodone-Acetaminophen

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2019-04-23
Est. Completion 2021-09-12
Phase Phase 3

What the finished NCT04246541 record still lists

NCT04246541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Ketorolac is the first listed.

NCT04246541 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04246541 about?

NCT04246541 is a clinical study titled "Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery". 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 proce...

What is the current status of trial NCT04246541?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2019-04-23. Estimated completion is 2021-09-12.

What interventions are being tested in trial NCT04246541?

The interventions under investigation include: Ketorolac (DRUG), Oxycodone-Acetaminophen (DRUG).

Who is sponsoring clinical trial NCT04246541?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04246541's enrollment target sits among peer trials

48 1862nd of 2000 higher than 134 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04246541, the US trial registry maintained by the National Library of Medicine. NCT04246541 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.