Ondansetron Reduce Vomiting Associated With Ketamine PSA

Ketamine

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.

Intervention / Treatment

  • Ondansetron (DRUG)
    ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Condition or Disease

  • Conscious Sedation

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 1 Year to 21 Years
    Enrollment: 268 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2002
    Primary Completion: Dec 01, 2006 ACTUAL
    Completion Date: Dec 01, 2006 ACTUAL
    Study First Posted: Oct 13, 2006 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 09, 2013

    Sponsors / Collaborators

    Lead Sponsor: University of Colorado, Denver
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Denver, Colorado, USA

    Participant Groups

    • ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

    • ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 21
    Age Groups: Child / Adult
    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.

    Primary Outcomes

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

    Secondary Outcomes

    • Secondary outcome measures were length of ED stay

    • patient or parent satisfaction with their sedation

    More Details

    NCT Number: NCT00387556
    Other IDs: 02-0528
    Study URL: https://clinicaltrials.gov/study/NCT00387556
    Last updated: Sep 29, 2023