Ondansetron Reduce Vomiting Associated With Ketamine PSA
- Registration Number
- NCT00387556
- Lead Sponsor
- University of Colorado, Denver
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine + Ondansetron Ondansetron ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg) Ketamine + Placebo Ondansetron ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
- Primary Outcome Measures
Name Time Method incidence of vomiting Duration of ED stay and after discharge The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
- Secondary Outcome Measures
Name Time Method Length of ED stay Duration of ED stay Secondary outcome measures were length of ED stay
Satisfaction with Sedation Length of ED stay. patient or parent satisfaction with their sedation
Trial Locations
- Locations (1)
The Childrens Hospital
🇺🇸Denver, Colorado, United States