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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Ketorolac; Ketorolac Tromethamine

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