Clinical trial NCT01387139: Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Official title: Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Procedural Sedation and Analgesia
Keywords: Ketamine
Propofol
Procedural Sedation and Analgesia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2011-07-04
Enrollment: 183
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Procedural sedation and analgesia (PSA) is a frequent occurrence in pediatric emergency departments. The goals of PSA include maximizing analgesia and amnesia, and minimizing adverse events while ensuring stable cardiopulmonary function. For decades, ketamine has been the main pharmacologic agent used for pediatric PSA. Numerous studies support the use of ketamine for sedation, amnesia, and analgesia on children undergoing painful procedures in the emergency department setting. Research has continually shown ketamine to cause emergence phenomenon, laryngospasm and vomiting.

Propofol is a sedative-hypnotic widely used for procedural sedation in adult emergency departments. The advantages of propofol include rapid onset, with quick and predictable recovery time, and antiemetic effects. Disadvantages include dose-dependent hypotension, bradycardia, respiratory depression, as well as pain with injection. In addition, propofol does not provide any analgesia.

Ketamine and propofol administered together have been successfully utilized in a variety of settings, including dermatologic, cardiovascular, and interventional radiological procedures in children. The co-administration of ketamine and propofol has been shown to preserve sedation while minimizing the respective adverse events. When used in combination, doses administered of each can be reduced, while producing a more stable hemodynamic and respiratory profile. Furthermore, this combination may reduce the frequency of emergence reactions, vomiting, and the pain of propofol injection.

To date, there are no randomized controlled trials evaluating the co-administration of ketamine and propofol versus ketamine monotherapy for PSA in the Pediatric Emergency Department.

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

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: From enrollment through completion of follow-up, up to 7 days
Secondary outcomes:
measure: Recovery Time
timeFrame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour
measure: Efficacy of Sedation
timeFrame: After procedure is completed, on average less than 1 hour
measure: Parent Satisfaction
timeFrame: After procedure is completed, on average less than 1 hour
measure: Physician Performing Procedure Satisfaction
timeFrame: After procedure is completed, on average less than 1 hour
measure: Nurse Satisfaction
timeFrame: After procedure is completed, on average less than 1 hour
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Lalit Bajaj, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Keith Weisz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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