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Fentofol for Fracture Reduction

Phase 3
Waitlist Available
Led By Vikram Sabhaney, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of psa until 48 to 72 hours post-ed discharge
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Procedural Sedation
  • Fracture Reduction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of psa until 48 to 72 hours post-ed discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of psa until 48 to 72 hours post-ed discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of Sedation
Secondary study objectives
Additional analgesia or sedation medications
Efficacy of sedation for completion of procedure
Incidence of adverse events
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FentofolExperimental Treatment1 Intervention
Patient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol.
Group II: KetofolActive Control1 Intervention
Patient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fentofol
2014
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,426 Total Patients Enrolled
Child and Family Research InstituteOTHER
6 Previous Clinical Trials
9,510 Total Patients Enrolled
Vikram Sabhaney, MDPrincipal InvestigatorUniversity of British Columbia, BC Children's Hospital
~3 spots leftby Nov 2025
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