Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Management Following Cardiopulmonary Bypass Surgery
Intervention: Ketorolac (Drug); Placebo (Other)
Phase: Phase 4
Sponsored by: Weill Medical College of Cornell University
Official(s) and/or principal investigator(s):
Gergory Kerr, M.D., MBA, Principal Investigator, Affiliation: Weill Medical College of Cornell University, New York Presbyterian Hospital
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.
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Total morphine administered
Chest tube drainage
Respiratory Assessments (NIF, VC)
VAS Pain Scale
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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
- Capable of speaking and understanding English sufficiently to provide written informed
consent and responses to pain assessment scales and neurological questionnaires.
- 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
Locations and Contacts
New York Presbyterian Hospital, Weill Cornell Medical College, New York, New York 10021, United States
Starting date: January 2004
Ending date: June 2006
Last updated: March 7, 2008