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Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

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ClinicalTrials.gov Identifier: NCT00596050
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE January 16, 2008
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
OSBD-r [ Time Frame: immediate ]
Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
OSBD-r [ Time Frame: immediate ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
  • Likert satisfaction scale [ Time Frame: immediate ]
    Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.
  • procedural recall [ Time Frame: immediate ]
    Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
  • Likert satisfaction scale [ Time Frame: immediate ]
  • procedural recall [ Time Frame: immediate ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Official Title  ICMJE Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Brief Summary There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.
Detailed Description There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Conscious Sedation Failure During Procedure
Intervention  ICMJE
  • Drug: ketamine and midazolam
    ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
  • Drug: etomidate, fentanyl, and lidocaine
    etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
Study Arms  ICMJE
  • Active Comparator: ketamine and midazolam
    ketamine and midazolam
    Intervention: Drug: ketamine and midazolam
  • Active Comparator: etomidate and fentanyl and lidocaine
    etomidate and fentanyl and lidocaine
    Intervention: Drug: etomidate, fentanyl, and lidocaine
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: January 15, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 5-18 years
  • extremity fracture requiring reduction with sedation in emergency department

Exclusion Criteria:

  • allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine
  • multi-system trauma
  • history of psychosis
  • pregnancy
  • illicit drug use
  • developmental delay
  • non-english speaker
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00596050
Other Study ID Numbers  ICMJE 16271
Project No 1041266 ( Other Identifier: drexel )
Action No 47488 ( Other Identifier: drexel )
Detail No 240976 ( Other Identifier: drexel )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Drexel University ( Drexel University College of Medicine )
Study Sponsor  ICMJE Drexel University College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jannet J Lee-Jayaram, M.D. Drexel University College of Medicine
PRS Account Drexel University
Verification Date May 2017

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