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

Not Applicable

• Conditions: Sedation and Analgesia; Side Effect of Drug
• Interventions: Drug: Ondansetron

• Registration Number: NCT01477242
• Lead Sponsor: Seoul National University Hospital

Brief 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

Study Timeline

• Study First Submitted: 2011-10-23
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-19
• Last Update Posted: 2012-01-20
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron	Ondansetron use group
Placebo	Ondansetron	Placebo group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
parent's satisfaction	satisfaction will be surveyed within 48hours after discharge
length of emergency department stay	length of stay will be calculated upto 24 hours

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of