Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Child and Family Research Institute
• Treatments: Fentanyl; Ketamine; Propofol

Criteria

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

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