Ondansetron Reduce Vomiting Associated With Ketamine PSA

This study has been completed.

First Received: October 12, 2006 No Changes Posted

Sponsor:	The Children's Hospital, Denver
Information provided by:	The Children's Hospital, Denver
ClinicalTrials.gov Identifier:	NCT00387556

Purpose

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

Condition	Intervention
Conscious Sedation	Drug: Ondansetron

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by The Children's Hospital, Denver:

Primary Outcome Measures:

incidence of vomiting

Secondary Outcome Measures:

NPO status
adverse events

Estimated Enrollment:	500
Study Start Date:	December 2002
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387556

Locations

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

Sponsors and Collaborators

The Children's Hospital, Denver

Investigators

Principal Investigator:

Joe E Wathen, MD

University of Colorado Health Science Center

More Information

No publications provided

Study ID Numbers:	02-528
Study First Received:	October 12, 2006
Last Updated:	October 12, 2006
ClinicalTrials.gov Identifier:	NCT00387556 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Children's Hospital, Denver:

ketamine
children
emesis

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Antiemetics
Excitatory Amino Acid Agents
Serotonin Antagonists
Sensory System Agents
Therapeutic Uses
Ketamine
Antipruritics
Ondansetron
Analgesics
Dermatologic Agents

Excitatory Amino Acid Antagonists
Anesthetics, Intravenous
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Anesthetics, Dissociative
Serotonin Agents
Anesthetics, General
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010