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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00161577
First Posted: September 12, 2005
Last Update Posted: May 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Weill Medical College of Cornell University
  Purpose
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.

Condition Intervention Phase
Pain Management Following Cardiopulmonary Bypass Surgery Drug: Ketorolac Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Ketorolac in the Management of Post-Operative Pain After Heart Surgery

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Total morphine administered [ Time Frame: 24 hours post operatively ]

Secondary Outcome Measures:
  • Chest tube drainage [ Time Frame: 24 hours post operatively ]
  • Respiratory Assessments (NIF, VC) [ Time Frame: 24 hours post operatively ]
  • VAS Pain Scale [ Time Frame: 24 hours post operatively ]

Enrollment: 25
Study Start Date: January 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Group A = Ketorolac
Drug: Ketorolac
Intravenous ketorolac every 6 hours for 24 hours
Other Name: Toradol
Placebo Comparator: B Other: Placebo
Placebo Comparator

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161577


Locations
United States, New York
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Gergory Kerr, M.D., MBA Weill Medical College of Cornell University, New York Presbyterian Hospital
  More Information

Responsible Party: Gregory Kerr, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00161577     History of Changes
Other Study ID Numbers: 0903-886
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: May 13, 2009
Last Verified: May 2009

Keywords provided by Weill Medical College of Cornell University:
Ketorolac

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action