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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01477242
• Other study ID #: H-1105-114-364
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2011
• Last updated: January 19, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2012
• Source: Seoul National University Hospital
• Contact: Do Kyun Kim, M.D.
• Phone: 82-2-2072-0238
• Email: birdbeak[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months and older

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Myongji Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	parent's satisfaction		satisfaction will be surveyed within 48hours after discharge	No
Secondary	length of emergency department stay		length of stay will be calculated upto 24 hours	No