Ondansetron Reduce Vomiting Associated With Ketamine PSA

Overview

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

Full Title of Study: “Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2006

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Ketamine + Ondansetron
    • ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
  • Placebo Comparator: Ketamine + Placebo
    • ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo

Clinical Trial Outcome Measures

Primary Measures

  • incidence of vomiting
    • Time Frame: 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 Measures

  • Length of ED stay
    • Time Frame: Duration of ED stay
    • Secondary outcome measures were length of ED stay
  • Satisfaction with Sedation
    • Time Frame: Length of ED stay.
    • patient or parent satisfaction with their sedation

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joe E Wathen, MD, Principal Investigator, University of Colorado Health Science Center

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