Emergency Department Procedural Sedation Clinical Trial
Official title:
Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01211158 -
Ketofol vs Propofol for Emergency Department Procedural Sedation and Analgesia
|
Phase 3 |