CompletedPhase 3ketamine

Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

Sponsored by University of British Columbia

NCT ID
NCT02079090
Target Enrollment
30 participants
Start Date
2014-07
Est. Completion
2017-06

About This Study

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.

Conditions Studied

Emergency Department Procedural SedationFracture Reduction

Interventions

  • Ketofol
  • Fentofol

Eligibility

Age:3 Years - 17 Years
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source