Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00596050
First received: January 7, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Procedural Sedation
Drug: ketamine and midazolam
Drug: etomidate, fentanyl, lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • OSBD-r [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Likert satisfaction scale [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • procedural recall [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ketamine and midazolam
Drug: ketamine and midazolam
ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
Experimental: 2
etomidate and fentanyl and lidocaine
Drug: etomidate, fentanyl, lidocaine
etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00596050

Locations
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Sponsors and Collaborators
Drexel University College of Medicine
Investigators
Principal Investigator: Jannet J Lee-Jayaram, M.D. Drexel University College of Medicine
  More Information

Publications:
Jay SM, Ozolins M, Elliott C, Caldwell S. Assessment of children's distress during painful medical procedures. J Health Psycho. 1983; 2: 133-147

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00596050     History of Changes
Other Study ID Numbers: 16271, Project No 1041266, Action No 47488, Detail No 240976
Study First Received: January 7, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
procedural sedation
fracture reduction
pediatric emergency medicine
etomidate
ketamine
analgesia

Additional relevant MeSH terms:
Ketamine
Fentanyl
Midazolam
Etomidate
Lidocaine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
GABA Modulators
GABA Agents
Narcotics
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 28, 2014