Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

Phase 3

Completed

• Conditions: Emergency Department Procedural Sedation; Fracture Reduction
• Interventions: Drug: Ketofol; Drug: Fentofol

• Registration Number: NCT02079090
• Lead Sponsor: University of British Columbia

Brief 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.

Study Timeline

• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Study Start: 2014-07
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children 3-17 years of age
• Presenting to the ED for assessment of a long bone fracture
• Require PSA for closed reduction of the fracture
• American Society of Anesthesia Grade I or II

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Exclusion Criteria

• Families not providing informed consent (or assent where appropriate)
• Families unable to communicate in English
• Children sustained life- or limb-threatening injuries
• Children involved in a multi-system trauma
• Children with a pathological fractures
• Children with a contraindication to using Propofol, Ketamine or Fentanyl:

Allergy or previous adverse reaction to study drugs Psychosis/schizophrenia Active upper respiratory tract infection or asthma, or chronic respiratory illnesses Coronary artery disease, congestive heart failure, hypertension, or chronic cardiac disease Chronic renal disease Increased intracranial pressure Porphyria or thyroid disorder

• Severe developmental delay or autism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketofol	Ketofol	Patient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol.
Fentofol	Fentofol	Patient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol.

Primary Outcome Measures

Name	Time	Method
Duration of Sedation	Less than 30 minutes	Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.

Secondary Outcome Measures

Name	Time	Method
Efficacy of sedation for completion of procedure	Less than 30 minutes	A sedation is considered efficacious if: the patient does not have unpleasant recall of the procedure, the patient did not experience sedation-related adverse events resulting in abandonment of the procedure/permanent complication/unplanned admission to the hospital or ED, and the patient did not actively resist the procedure or require restraints.
Recovery Time	Less than 30 minutes	Measured from time of last dose of study drug administered to recovery
Incidence of adverse events	From initiation of PSA until 48 to 72 hours post-ED discharge	Adverse events, interventions and outcomes will be measured using the "Quebec Guidelines".
Additional analgesia or sedation medications	Less than 30 minutes	Use of additional analgesic agents and sedation medications to complete PSA
Satisfaction with sedation	Less than 60 minutes	Satisfaction scores will be completed by the physician performing the sedation, the physician performing the procedure, the nurse performing the sedation and by the patient in the ED. This outcome will by measured using a 5-point Likert scale, except in children between ages 6 and 9, where a 5-point facial hedonic scale is used.

Trial Locations

Locations (1)

University of British Columbia: BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada