Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery

May 12, 2009 updated by: Weill Medical College of Cornell University

Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Ketorolac in the Management of Post-Operative Pain After Heart Surgery

This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current practice at this institution does not include routine use of ketorolac for post-operative pain management of patients undergoing cardiac surgery. The investigators hypothesize that using Ketorolac as an adjunct to IV morphine can positively impact patient outcomes and reduce the occurrence of possible side effects.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

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, 10021
        • New York Presbyterian Hospital, Weill Cornell Medical College

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females > 18 years of age at the screening visit.
  • Undergoing coronary artery bypass graft or single valve repair or replacement requiring cardiopulmonary bypass.
  • American Society of Anesthesiology (ASA) Physical Class 3, or 4.
  • Willing able to use a PCA Pump
  • Willing to receive iv morphine for 24 hours post initial ketorolac dose to control pain.
  • Capable of speaking and understanding English sufficiently to provide written informed consent and responses to pain assessment scales and neurological questionnaires.

Exclusion Criteria:

  • Allergy or sensitivity to nonsteroidal anti-inflammatory drugs
  • History of gastrointestinal bleeding or peptic ulcer
  • Serum creatinine = 2.0 mg/dl or rise in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days if known with the exception of patients with Dialysis Dependent End Stage Renal Disease (ESRD).
  • Hepatic dysfunction
  • Patients with low cardiac output syndrome (cardiac index < 2.0) after cardiopulmonary bypass or pre-op ejection fraction < 30%
  • Inability to operate PCA pump
  • Cardiothoracic reoperations
  • Bleeding disorder

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Other: Placebo
Placebo Comparator
Other: A
Group A = Ketorolac
Drug: Ketorolac
Intravenous ketorolac every 6 hours for 24 hours
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total morphine administered
Time Frame: 24 hours post operatively
24 hours post operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Chest tube drainage
Time Frame: 24 hours post operatively
24 hours post operatively
Respiratory Assessments (NIF, VC)
Time Frame: 24 hours post operatively
24 hours post operatively
VAS Pain Scale
Time Frame: 24 hours post operatively
24 hours post operatively

Collaborators and Investigators

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

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Gergory Kerr, M.D., MBA, Weill Medical College of Cornell University, 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

January 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2009

Last Update Submitted That Met QC Criteria

May 12, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0903-886

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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