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Ondansetron Reduce Vomiting Associated With Ketamine PSA

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00387556
Collaborator
(none)
268
Enrollment
1
Location
2
Arms
48
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
268 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Zofran

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidence of vomiting [Duration of ED stay and after discharge]

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

    Secondary Outcome Measures

    1. Length of ED stay [Duration of ED stay]

      Secondary outcome measures were length of ED stay

    2. Satisfaction with Sedation [Length of ED stay.]

      patient or parent satisfaction with their sedation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT00387556
    Other Study ID Numbers:
    • 02-0528
    First Posted:
    Oct 13, 2006
    Last Update Posted:
    May 13, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by University of Colorado, Denver
    ketamine
    children
    emesis
    Additional relevant MeSH terms:
    Vomiting
    Ondansetron

    Study Results

    No Results Posted as of May 13, 2013