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Ondansetron Reduce Vomiting Associated With Ketamine PSA

Information source: The Children's Hospital, Denver
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Conscious Sedation

Intervention: Ondansetron (Drug)

Phase: N/A

Status: Completed

Sponsored by: The Children's Hospital, Denver

Official(s) and/or principal investigator(s):
Joe E Wathen, MD, Principal Investigator, Affiliation: University of Colorado Health Science Center

Summary

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

Clinical Details

Official title: Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: incidence of vomiting

Secondary outcome:

NPO status

adverse events

Eligibility

Minimum age: 1 Year. Maximum age: 21 Years. Gender(s): Both.

Criteria:

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 and Contacts

The Childrens Hospital, Denver, Colorado 80218, United States
Additional Information

Starting date: December 2002
Ending date: October 2006
Last updated: October 12, 2006

Page last updated: June 20, 2008

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