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

Condition(s) targeted: Sedation and Analgesia; Side Effect of Drug

Intervention: Ondansetron (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Do Kyun Kim, M.D., Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Do Kyun Kim, M.D., Phone: 82-2-2072-0238, Email: birdbeak@naver.com

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.

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

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

Primary outcome: vomiting at ED stay and 12 hours after discharge

Secondary outcome:

parent's satisfaction

length of emergency department stay

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

Minimum age: 3 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Do Kyun Kim, M.D., Phone: 82-2-2072-0238, Email: birdbeak@naver.com

Seoul National University Hospital, Seoul 110744, Korea, Republic of; Recruiting
Do Kyun Kim, M.D., Phone: 82-2-2072-0238
Do Kyun Kim, M.D., Principal Investigator
Jae Yun Jung, M.D., Sub-Investigator

Starting date: November 2011
Last updated: January 19, 2012