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Ondansetron Reduce Vomiting Associated With Ketamine PSA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00387556
First received: October 12, 2006
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • incidence of vomiting [ Time Frame: Duration of ED stay and after discharge ] [ Designated as safety issue: No ]
    The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up


Secondary Outcome Measures:
  • Length of ED stay [ Time Frame: Duration of ED stay ] [ Designated as safety issue: No ]
    Secondary outcome measures were length of ED stay

  • Satisfaction with Sedation [ Time Frame: Length of ED stay. ] [ Designated as safety issue: No ]
    patient or parent satisfaction with their sedation


Enrollment: 268
Study Start Date: December 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine + Ondansetron
ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
 Drug: Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other Name: Zofran
Placebo Comparator: Ketamine + Placebo
ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
 Drug: Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other Name: Zofran

  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
University of Colorado, Denver
Investigators
Principal Investigator: Joe E Wathen, MD University of Colorado Health Science Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00387556     History of Changes
Other Study ID Numbers: 02-0528
Study First Received: October 12, 2006
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
ketamine
children
emesis

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ketamine
Ondansetron
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
 Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 16, 2013