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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Procedural Sedation and Analgesia

Treatments: Drug: Ketamine Co-administered with Propofol; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01387139

10-0835

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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183 participants in 2 patient groups

Ketamine Alone

Active Comparator group

Description:

1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)

Treatment:

Drug: Ketamine

Ketamine Co-Administered with Propofol

Experimental group

Description:

0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)

Treatment:

Drug: Ketamine Co-administered with Propofol