Ondansetron Reduce Vomiting Associated With Ketamine PSA

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

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-12-31

Brief Summary

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Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.

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Detailed Description

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Conditions

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Conscious Sedation

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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Ketamine + Ondansetron

ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Ketamine + Placebo

ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo

Group Type PLACEBO_COMPARATOR

Ondansetron

Intervention Type DRUG

ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Interventions

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Ondansetron

ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Intervention Type DRUG

Other Intervention Names

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Zofran

Eligibility Criteria

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Inclusion Criteria

* age 1-21 years, ASA I or II, fracture of dislocation reduction

Exclusion Criteria

* age \< 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes