Phase 3
N=183
Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Procedural Sedation and Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT01387139 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Frequency of Adverse Events — 12; 15; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketamine (Drug); Ketamine Co-administered with Propofol (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events |
12; 15; 1; 0; 21; 18 | — |
| SECONDARY Recovery Time |
44; 43.5 | — |
| SECONDARY Efficacy of Sedation |
97; 81 | — |
| SECONDARY Parent Satisfaction |
10; 10 | — |
| SECONDARY Physician Performing Procedure Satisfaction |
9; 8 | — |
| SECONDARY Nurse Satisfaction |
10; 8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Ages > 3 years and 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
Data sourced from ClinicalTrials.gov (NCT01387139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.