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

• Frequency of Adverse Events [ Time Frame: From enrollment through completion of follow-up, up to 7 days ] [ Designated as safety issue: Yes ]
  We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.
  
  

• Recovery Time [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
  Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.
  
  
• Efficacy of Sedation [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]

  Efficacy is defined as:

  1. The patient does not have unpleasant recall of the procedure.
  2. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation
  3. The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.
  4. The procedure was successful
  
  
• Levels of Ketamine and Propofol in the blood measured in nanograms per milliliter (ml) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  
• Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  
• Parent satisfaction [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
  Measured on a 10-point scale
  
  
• Patient Satisfaction [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ] [ Designated as safety issue: No ]
  Measured on a 10-point scale
  
  
• Physician Performing Procedure Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]
  Measured on a 10-point scale
  
  
• Nurse Satisfaction [ Time Frame: After procedure is completed, on average less than 1 hour ] [ Designated as safety issue: No ]
  Measured on a 10-point scale
  
  
• Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  
• Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  
• Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  
• Levels of Ketamine and Propofol in the blood measured in nanograms per ml [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  
• Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  
• Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  
• Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  
• Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  

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.