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Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

NCT02079090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-10-27

No results posted yet for this study

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.

Conditions

  • Emergency Department Procedural Sedation
  • Fracture Reduction

Interventions

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)

Sponsors & Collaborators

  • Child and Family Research Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Vikram Sabhaney, MD · University of British Columbia, BC Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079090 on ClinicalTrials.gov