Back to resultsThe Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
Primary Purpose
Sedation and Analgesia, Side Effect of Drug
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Sedation and Analgesia focused on measuring vomiting, anti-emetics, ketamine, sedation
Eligibility Criteria
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ondansetron
Placebo
Arm Description
Ondansetron use group
Placebo group
Outcomes
Primary Outcome Measures
vomiting at ED stay and 12 hours after discharge
Secondary Outcome Measures
parent's satisfaction
length of emergency department stay
Full Information
NCT ID
NCT01477242
First Posted
October 23, 2011
Last Updated
January 19, 2012
Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Myongji Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01477242
Brief Title
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
Official Title
The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Myongji Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation and Analgesia, Side Effect of Drug
Keywords
vomiting, anti-emetics, ketamine, sedation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
266 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron use group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran zydis, vomiset
Intervention Description
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
Primary Outcome Measure Information:
Title
vomiting at ED stay and 12 hours after discharge
Time Frame
the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge
Secondary Outcome Measure Information:
Title
parent's satisfaction
Time Frame
satisfaction will be surveyed within 48hours after discharge
Title
length of emergency department stay
Time Frame
length of stay will be calculated upto 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do Kyun Kim, M.D.
Phone
82-2-2072-0238
Email
birdbeak@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Kyun Kim, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Kyun Kim, M.D.
Phone
82-2-2072-0238
First Name & Middle Initial & Last Name & Degree
Do Kyun Kim, M.D.
First Name & Middle Initial & Last Name & Degree
Jae Yun Jung, M.D.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
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