The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
NCT ID: NCT01477242
Last Updated: 2012-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
266 participants
INTERVENTIONAL
2011-11-30
2012-05-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ondansetron
Ondansetron use group
Ondansetron
2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg
Placebo
Placebo group
Ondansetron
2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg
Interventions
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Ondansetron
2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* children who are planned to admit ketamine intramuscular injection
* children with ASA classification class I or II
Exclusion Criteria
* 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
3 Months
ALL
Yes
Sponsors
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Asan Medical Center
OTHER
Myongji Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Do Kyun Kim
assistant professor
Principal Investigators
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Do Kyun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Do Kyun Kim, M.D.
Role: primary
Other Identifiers
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H-1105-114-364
Identifier Type: -
Identifier Source: org_study_id
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