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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain Management Following Cardiopulmonary Bypass Surgery

In brief

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.

Key facts

Study ID

NCT00161577

Run by

Weill Medical College of Cornell University

People needed

25

Starts

2004-01-01

Expected to finish

2006-06-01

Last updated by the study team

2009-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York Presbyterian Hospital, Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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