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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477242

Enrollment

266

Registered

2011-11-22

Start date

2011-11-30

Completion date

2012-05-31

Last updated

2012-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation and Analgesia, Side Effect of Drug

Keywords

vomiting, anti-emetics, ketamine, sedation

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

Interventions

DRUGOndansetron

2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Months to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Contacts

Primary ContactDo Kyun Kim, M.D.

birdbeak@naver.com82-2-2072-0238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026