Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
NCT ID: NCT00161577
Last Updated: 2009-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2004-01-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Group A = Ketorolac
Ketorolac
Intravenous ketorolac every 6 hours for 24 hours
B
Placebo
Placebo Comparator
Interventions
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Ketorolac
Intravenous ketorolac every 6 hours for 24 hours
Placebo
Placebo Comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Weill Cornell Medical College
Principal Investigators
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Gergory Kerr, M.D., MBA
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University, New York Presbyterian Hospital
Locations
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New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States
Countries
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Other Identifiers
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0903-886
Identifier Type: -
Identifier Source: org_study_id
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