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

Condition(s) targeted: Pain Management Following Cardiopulmonary Bypass Surgery

Intervention: Ketorolac (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

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

Secondary outcome:

Chest tube drainage

Respiratory Assessments (NIF, VC)

VAS Pain Scale

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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