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

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. Identifier: NCT00161577
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 13, 2009
Information provided by:
Weill Medical College of Cornell University

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Management Following Cardiopulmonary Bypass Surgery Drug: Ketorolac Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : January 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Ketorolac

Arm Intervention/treatment
Group A = Ketorolac
Drug: Ketorolac
Intravenous ketorolac every 6 hours for 24 hours
Other Name: Toradol

Placebo Comparator: B Other: Placebo
Placebo Comparator

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00161577

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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
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Principal Investigator: Gergory Kerr, M.D., MBA Weill Medical College of Cornell University, New York Presbyterian Hospital
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Responsible Party: Gregory Kerr, MD, Weill Cornell Medical College Identifier: NCT00161577    
Other Study ID Numbers: 0903-886
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 13, 2009
Last Verified: May 2009
Keywords provided by Weill Medical College of Cornell University:
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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