Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

NCT ID: NCT00845754

Last Updated: 2009-02-18

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

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2001-08-31

Brief Summary

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The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.

Detailed Description

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Conditions

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Febrile Morbidity Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

15mg IV every 6hrs for 4 doses

2

Ketorolac

Group Type ACTIVE_COMPARATOR

ketorolac

Intervention Type DRUG

15mg IV every6 hours for 4doses

Interventions

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ketorolac

15mg IV every6 hours for 4doses

Intervention Type DRUG

saline

15mg IV every 6hrs for 4 doses

Intervention Type DRUG

Other Intervention Names

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Toradol

Eligibility Criteria

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Inclusion Criteria

* Ant patient undregoing abdominal myomectomy

Exclusion Criteria

* Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Ascher-Walsh, Charles, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Mount Sinai School of Medicine

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ASW 124

Identifier Type: -

Identifier Source: org_study_id

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