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

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00161577

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Surgery

Drug Information available for: Ketorolac Ketorolac tromethamine

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
B: Placebo Comparator	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

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

Keywords provided by Weill Medical College of Cornell University:

Ketorolac

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Ketorolac
Physiological Effects of Drugs
Enzyme Inhibitors
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Ketorolac Tromethamine
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010