Ondansetron Reduce Vomiting Associated With Ketamine PSA

University of Colorado, Denver268 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

268

Conditions

Conscious Sedation

Interventions

OndansetronDRUG

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Childrens Hospital

Denver, Colorado, United States

Outcomes

Primary Outcomes

incidence of vomiting

The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up

Time frame: Duration of ED stay and after discharge

Secondary Outcomes

Length of ED stay

Secondary outcome measures were length of ED stay

Time frame: Duration of ED stay

Satisfaction with Sedation

patient or parent satisfaction with their sedation

Time frame: Length of ED stay.

Data from ClinicalTrials.gov

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