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

Pain Management Following Cardiopulmonary Bypass Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161577
• Other study ID #: 0903-886
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: May 12, 2009
• Start date: January 2004
• Est. completion date: June 2006

Study information

• Verified date: May 2009
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Management Following Cardiopulmonary Bypass Surgery
• Pain, Postoperative

Intervention

Drug:
• Ketorolac
Intravenous ketorolac every 6 hours for 24 hours

Other:
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital, Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine administered		24 hours post operatively	No
Secondary	Chest tube drainage		24 hours post operatively	Yes
Secondary	Respiratory Assessments (NIF, VC)		24 hours post operatively	No
Secondary	VAS Pain Scale		24 hours post operatively	No