NCT02079090

Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emergency Department Procedural Sedation
• Fracture Reduction

Interventions

Type	Name	Description
DRUG	Ketofol	0.5 mg/kg Ketamine IV, and 2 minutes later receive 1 mg/kg Propofol (Diprivan).
DRUG	Fentofol	1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol (Diprivan)

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-03-05
• Last updated: 2017-10-27

Locations

1 site across 1 country: Canada