Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

February 17, 2009 updated by: Ascher-Walsh, Charles, M.D.

Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients

The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

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
    • New York
      • New York, New York, United States, 10032
        • Columbia University 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ant patient undregoing abdominal myomectomy

Exclusion Criteria:

  • Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: saline
15mg IV every 6hrs for 4 doses
Active Comparator: 2
Ketorolac
Drug: ketorolac
15mg IV every6 hours for 4doses
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative febrile morbidity
Time Frame: Inital 24hrs post-operative
Inital 24hrs post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative pain management
Time Frame: Initial 24hrs post-operative
Initial 24hrs post-operative

Collaborators and Investigators

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

Sponsor

Ascher-Walsh, Charles, M.D.

Collaborators

Icahn School of Medicine at Mount Sinai
New York Presbyterian Hospital

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

September 1, 1999

Primary Completion (Actual)

August 1, 2001

Study Completion (Actual)

August 1, 2001

Study Registration Dates

First Submitted

February 14, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASW 124

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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