Status:
UNKNOWN
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Asan Medical Center
Myongji Hospital
Conditions:
Sedation and Analgesia
Side Effect of Drug
Eligibility:
All Genders
3+ years
Phase:
NA
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 stu...
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 ...
Eligibility Criteria
Inclusion
- children under 18 years of age
- children who are planned to admit ketamine intramuscular injection
- children with ASA classification class I or II
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT01477242
Start Date
November 1 2011
End Date
May 1 2012
Last Update
January 20 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110744