Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department
Condition: Emergency Department Procedural Sedation; Fracture Reduction
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 3

Summary: 
      Sedation and pain medication is required when bone fractures need to be fixed in the
      emergency department (ED). Many drugs have been used safely as single agents or in
      combination for the sedation of children. These drugs include Propofol, Ketamine and
      Fentanyl. However each of these medications has side effects and drawbacks. The combination
      of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of
      Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study
      is to determine which combination works better. The primary outcome of this study is to
      determine which drug combination has a shorter time from onset of sedation to full recovery.
      The investigators hypothesize that Fentofol will have shorter sedation to recovery times.
    

Detailed description: 
      Purpose: The purpose of this study is to compare the duration of procedural sedation and
      analgesia (PSA) from time of medication delivery to recovery for children in the ED provided
      by Fentofol and Ketofol.

      Hypothesis: The hypothesis is that Fentofol will have a shorter duration of sedation time as
      compared to Ketofol.

      Justification: PSA for children is a common occurrence in the ED and has been performed using
      Ketamine or Propofol. Propofol offers several advantages over Ketamine, including shorter
      recovery times, and low rates of nausea and vomiting. Propofol is a potent sedative-hypnotic
      that does not provide analgesia, hence another agent is commonly used in combination for
      painful procedures. Propofol has been used in combination with Ketamine (Ketofol) and with
      Fentanyl (Fentofol) to improve the quality of sedation for painful procedures such as
      fracture reduction. Ketofol has been shown in a double blind randomized controlled trial to
      be at least equivalent, or even superior to Ketamine in children who are undergoing PSA, with
      shorter duration of sedation, increased provider and patient satisfaction, and reduced
      frequency of nausea/vomiting events. A combination of 1 to 2 microgram/kg Fentanyl and 1
      mg/kg Propofol has been shown to substantially reduce recovery time as compared to 0.05 mg/kg
      Midazolam and 1 to 2 mg/kg Ketamine, and provided adequate levels of analgesia during PSA. As
      a result, both Ketofol and Fentofol are considered standard treatments for PSA in the ED.
      However, there is currently no pediatric literature available comparing Ketofol and Fentofol
      for PSA in the ED setting and the results of this study will potentially identify which of
      the two sedation agents is superior.
    

Intervention name(s): Ketofol; Fentofol
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/kg Ketamine IV, and 2 minutes later receive 1 mg/kg Propofol (Diprivan).; 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol (Diprivan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Propofol; Ketamine; Fentanyl; Procedural sedation; children; Emergency Department