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

Primary Purpose

Pain Management Following Cardiopulmonary Bypass Surgery

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Management Following Cardiopulmonary Bypass Surgery focused on measuring Ketorolac

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital, Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

A

B

Arm Description

Group A = Ketorolac

Outcomes

Primary Outcome Measures

Total morphine administered

Secondary Outcome Measures

Chest tube drainage
Respiratory Assessments (NIF, VC)
VAS Pain Scale

Full Information

First Posted
September 7, 2005
Last Updated
May 12, 2009
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00161577
Brief Title
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management Following Cardiopulmonary Bypass Surgery
Keywords
Ketorolac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Group A = Ketorolac
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Intravenous ketorolac every 6 hours for 24 hours
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Total morphine administered
Time Frame
24 hours post operatively
Secondary Outcome Measure Information:
Title
Chest tube drainage
Time Frame
24 hours post operatively
Title
Respiratory Assessments (NIF, VC)
Time Frame
24 hours post operatively
Title
VAS Pain Scale
Time Frame
24 hours post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gergory Kerr, M.D., MBA
Organizational Affiliation
Weill Medical College of Cornell University, New York Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital, Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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