Oral Ketorolac for Arthroscopic Rotator Cuff Repair

April 14, 2022 updated by: Robert J. Gillespie, University Hospitals Cleveland Medical Center

Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair

  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 arthroscopic rotator cuff repair.
  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 arthroscopic rotator cuff repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Patients between the ages of 18 and 89 years old, male or female
  2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

  1. Patients below the age of 18 or above the age of 89
  2. Illiterate or non-English speaking patients
  3. Patients with contraindications to Ketorolac
  4. History of alcohol of drug abuse
  5. Chronic use of analgesic or psychotropic drugs
  6. Known peptic ulcer disease or bleeding diathesis
  7. Renal dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Ketorolac
Drug: Ketorolac
Oral Ketorolac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Visual Analog Scale Scores
Time Frame: participants were assessed at one single time point up to 8 weeks.
The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.
participants were assessed at one single time point up to 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Retear of Rotator Cuff Repair
Time Frame: 6 months
Assessing retear of rotator cuff repair on postop MRI.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

May 17, 2021

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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