Status:
COMPLETED
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Pain Management Following Cardiopulmonary Bypass Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 requiremen...
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 Ketor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00161577
Start Date
January 1 2004
End Date
June 1 2006
Last Update
May 13 2009
Active Locations (1)
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1
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States, 10021