Side Effect of Drug Clinical Trial
Official title:
The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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