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

NCT ID: NCT00161577

Last Updated: 2009-05-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Pain Management Following Cardiopulmonary Bypass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group A = Ketorolac

Group Type OTHER

Ketorolac

Intervention Type DRUG

Intravenous ketorolac every 6 hours for 24 hours

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Comparator

Interventions

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Ketorolac

Intravenous ketorolac every 6 hours for 24 hours

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type OTHER

Other Intervention Names

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Toradol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

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

Site Status

Countries

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United States

Other Identifiers

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0903-886

Identifier Type: -

Identifier Source: org_study_id

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