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

Phase 4

Completed

• Conditions: Pain Management Following Cardiopulmonary Bypass Surgery
• Interventions: Drug: Ketorolac; Other: Placebo

• Registration Number: NCT00161577
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-12
• Last Update Posted: 2009-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Ketorolac	Group A = Ketorolac
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total morphine administered	24 hours post operatively

Secondary Outcome Measures

Name	Time	Method
Chest tube drainage	24 hours post operatively
Respiratory Assessments (NIF, VC)	24 hours post operatively
VAS Pain Scale	24 hours post operatively

Trial Locations

Locations (1)

New York Presbyterian Hospital, Weill Cornell Medical College; 🇺🇸 New York, New York, United States