NCT01477242

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

The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Accepted

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.

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

Conditions

• Sedation and Analgesia
• Side Effect of Drug

Interventions

Type	Name	Description
DRUG	Ondansetron	2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-11-22
• Last updated: 2012-01-20

Locations

1 site across 1 country: South Korea