Back to resultsOndansetron Reduce Vomiting Associated With Ketamine PSA
Primary Purpose
Conscious Sedation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Conscious Sedation focused on measuring ketamine, children, emesis
Eligibility Criteria
Inclusion Criteria:
- age 1-21 years, ASA I or II, fracture of dislocation reduction
Exclusion Criteria:
- age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
Sites / Locations
- The Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine + Ondansetron
Ketamine + Placebo
Arm Description
ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
Outcomes
Primary Outcome Measures
incidence of vomiting
The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
Secondary Outcome Measures
Length of ED stay
Secondary outcome measures were length of ED stay
Satisfaction with Sedation
patient or parent satisfaction with their sedation
Full Information
NCT ID
NCT00387556
First Posted
October 12, 2006
Last Updated
May 9, 2013
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00387556
Brief Title
Ondansetron Reduce Vomiting Associated With Ketamine PSA
Official Title
Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conscious Sedation
Keywords
ketamine, children, emesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine + Ondansetron
Arm Type
Experimental
Arm Description
ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Arm Title
Ketamine + Placebo
Arm Type
Placebo Comparator
Arm Description
ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Primary Outcome Measure Information:
Title
incidence of vomiting
Description
The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
Time Frame
Duration of ED stay and after discharge
Secondary Outcome Measure Information:
Title
Length of ED stay
Description
Secondary outcome measures were length of ED stay
Time Frame
Duration of ED stay
Title
Satisfaction with Sedation
Description
patient or parent satisfaction with their sedation
Time Frame
Length of ED stay.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 1-21 years, ASA I or II, fracture of dislocation reduction
Exclusion Criteria:
age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe E Wathen, MD
Organizational Affiliation
University of Colorado Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Childrens Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
12. IPD Sharing Statement
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Ondansetron Reduce Vomiting Associated With Ketamine PSA
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