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

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00161577
First received: September 7, 2005
Last updated: May 12, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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

Primary Outcome Measures:
  • Total morphine administered [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chest tube drainage [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: Yes ]
  • Respiratory Assessments (NIF, VC) [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
  • VAS Pain Scale [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]

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
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gregory Kerr, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00161577     History of Changes
Other Study ID Numbers: 0903-886
Study First Received: September 7, 2005
Last Updated: May 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Ketorolac

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013