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

Completed · Phase 3

Conditions studied: Procedural Sedation and Analgesia

In brief

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.

Key facts

Study ID

NCT01387139

Run by

University of Colorado, Denver

People needed

183

Starts

2011-01-01

Expected to finish

2017-11-03

Last updated by the study team

2017-12-08

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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