Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Condition: Procedural Sedation and Analgesia
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Ketamine; Ketamine Co-administered with Propofol
Intervention type(s): Drug; Drug
Intervention description(s): 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); 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)
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Propofol; Procedural Sedation and Analgesia