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

Side Effect of Drug Clinical Trial

Official title: The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Sedation and Analgesia
• Side Effect of Drug

• NCT number: NCT01477242
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Do Kyun Kim, M.D.
• Phone: 82-2-2072-0238
• Email: birdbeak@naver.com
• Status: Recruiting
• Phase: N/A
• Start date: November 2011
• Completion date: May 2012