Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

• Status: Completed
• Trial end date: 2017-11-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Colorado Clinical & Translational Sciences Institute
• Treatments: Ketamine; Propofol

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