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

Seoul National University

Status: Unknown

Conditions: Side Effect of Drug; Sedation and Analgesia

Treatments: Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01477242

H-1105-114-364

Details and patient eligibility

About

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.

Full 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

Enrollment: 266 estimated patients

Sex: All

Ages: 3+ months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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266 participants in 2 patient groups, including a placebo group

Ondansetron

Experimental group

Description:

Ondansetron use group

Treatment:

Drug: Ondansetron

Placebo

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: Ondansetron