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Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

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ClinicalTrials.gov Identifier: NCT02079090
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Child and Family Research Institute
Information provided by (Responsible Party):
Vikram Sabhaney, University of British Columbia

Tracking Information
First Submitted Date  ICMJE March 1, 2014
First Posted Date  ICMJE March 5, 2014
Last Update Posted Date October 27, 2017
Study Start Date  ICMJE July 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
Duration of Sedation [ Time Frame: Less than 30 minutes ]
Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • Recovery Time [ Time Frame: Less than 30 minutes ]
    Measured from time of last dose of study drug administered to recovery
  • Additional analgesia or sedation medications [ Time Frame: Less than 30 minutes ]
    Use of additional analgesic agents and sedation medications to complete PSA
  • Efficacy of sedation for completion of procedure [ Time Frame: 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.
  • Satisfaction with sedation [ Time Frame: 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.
  • Incidence of adverse events [ Time Frame: From initiation of PSA until 48 to 72 hours post-ED discharge ]
    Adverse events, interventions and outcomes will be measured using the "Quebec Guidelines".
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • Recovery Time [ Time Frame: Less than 30 minutes ]
    Measured from time of last dose of study drug administered to recovery
  • Additional analgesia or sedation medications [ Time Frame: Less than 30 minutes ]
    Use of additional analgesic agents and sedation medications to complete PSA
  • Efficacy of sedation for completion of procedure [ Time Frame: 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.
  • Satisfaction with sedation [ Time Frame: Less than 60 minutes ]
    Satisfaction scores will be completed by the physician performing the sedation, the physician performing the procedure, 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.
  • Incidence of adverse events [ Time Frame: From initiation of PSA until 48 to 72 hours post-ED discharge ]
    Adverse events, interventions and outcomes will be measured using the "Quebec Guidelines".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department
Official Title  ICMJE Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Emergency Department Procedural Sedation
  • Fracture Reduction
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Ketofol
    Patient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol.
    Intervention: Drug: Ketofol
  • Experimental: Fentofol
    Patient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol.
    Intervention: Drug: Fentofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
140
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02079090
Other Study ID Numbers  ICMJE H14-00273
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vikram Sabhaney, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Child and Family Research Institute
Investigators  ICMJE
Principal Investigator: Vikram Sabhaney, MD University of British Columbia, BC Children's Hospital
PRS Account University of British Columbia
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP