At a glance
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Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Ketofol and Fentofol for Emergency Department Procedural Sedation and Fracture Reduction. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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)