CompletedPhase 3ketamine
Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Sponsored by University of Colorado, Denver
NCT ID
NCT01387139
Target Enrollment
183 participants
Start Date
2011-01
Est. Completion
2017-11-03
About This Study
The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.
Conditions Studied
Interventions
- •Ketamine
- •Ketamine Co-administered with Propofol
Eligibility
Age:3 Years - 21 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Ages \> 3 years and \< 21 years * American Society of Anesthesiologists (ASA) class I or II * Fracture or dislocation requiring reduction under procedural sedation with ketamine as deemed by the attending emergency medicine physician * Parent/Legal Guardian or Patient (if 18 years of age or older) has already given verbal consent for procedural sedation as part of standard care for their condition Exclusion Criteria: * Hypertension (Blood Pressure \> 95th percentile for age) * Glaucoma or acute globe injury * Increased intracranial pressure or central nervous system mass lesion * Porphyria * Previous allergic reaction to ketamine * Previous allergic reaction to Propofol or its components including soybean oil, glycerol, egg lecithin, and disodium edentate * Disorders of lipid metabolism including primary hyperlipoproteinemia, diabetic hyperlipemia, or pancreatitis * Mitochondrial myopathies or disorders of electron transport * Pregnancy * Parent, guardian or patient unwilling/unable to provide informed consent/assent
Study Locations (1)
Children's Hospital Colorado
Aurora, Colorado, United States