The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department

Overview

The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.

Full Title of Study: “The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

Detailed Description

Methods – a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED) – survey for the occurrence of vomiting at ED and after discharge Primary outcome – the number of vomiting at ED and at home Secondary outcome – parent's satisfaction and ED length of stay

Interventions

  • Drug: Ondansetron
    • 2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg

Arms, Groups and Cohorts

  • Experimental: Ondansetron
    • Ondansetron use group
  • Placebo Comparator: Placebo
    • Placebo group

Clinical Trial Outcome Measures

Primary Measures

  • vomiting at ED stay and 12 hours after discharge
    • Time Frame: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge

Secondary Measures

  • parent’s satisfaction
    • Time Frame: satisfaction will be surveyed within 48hours after discharge
  • length of emergency department stay
    • Time Frame: length of stay will be calculated upto 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • children under 18 years of age – children who are planned to admit ketamine intramuscular injection – children with ASA classification class I or II Exclusion Criteria:

  • don't want to enroll to study – children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria) – children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus) – children under 3 months of age – children whose weight are over 30 kg – children managed by other drug with ketamine

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Do Kyun Kim, assistant professor – Seoul National University Hospital
  • Overall Official(s)
    • Do Kyun Kim, M.D., Principal Investigator, Seoul National University Hospital
  • Overall Contact(s)
    • Do Kyun Kim, M.D., 82-2-2072-0238, birdbeak@naver.com

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