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Ondansetron Reduce Vomiting Associated With Ketamine PSA

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Conscious Sedation

Intervention: Ondansetron (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Colorado, 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: incidence of vomiting

Secondary outcome:

Length of ED stay

Satisfaction with Sedation

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
Last updated: May 9, 2013

Page last updated: August 23, 2015

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