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

November 24, 2021 updated by: Michael Karns, MD., University Hospitals Cleveland Medical Center
  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 ACL reconstruction surgery.
  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 ACL reconstruction surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

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
        • UH 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 18 and 89 years old
  • Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

  • Patients below age 18 or above age 89
  • Illiterate or non-English speaking individuals
  • Patients with contraindications to Ketorolac
  • History of chronic alcohol or drug abuse
  • Chronic use of psychotropic or analgesic drugs
  • Known peptic ulcer disease or bleeding diasthesis
  • Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
  • Breastfeeding women
  • Pregnant women

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
Experimental: Control
Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery
Drug: Oxycodone-Acetaminophen
Oral oxycodone-acetaminophen for post-operative pain control
Experimental: Ketorolac
Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control
Drug: Ketorolac
Oral ketorolac for pain control following ACL reconstruction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Visual Analogue Scale Scores
Time Frame: Up to 8 weeks postoperative
Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.
Up to 8 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Medication
Time Frame: 5 days
Number of oxycodone-acetaminophen tablets
5 days

Collaborators and Investigators

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

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Michael Karns, MD, University Hospital 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)

May 21, 2019

Primary Completion (Actual)

October 9, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20180985

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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