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: August 13, 2014
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
Conscious Sedation Failure During Procedure
Drug: ketamine and midazolam
Drug: etomidate, fentanyl, and 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: ketamine and midazolam
ketamine and midazolam
Drug: ketamine and midazolam
ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
Other Name: ketamine and midazolam
Active Comparator: etomidate and fentanyl and lidocaine
etomidate and fentanyl and lidocaine
Drug: etomidate, fentanyl, and lidocaine
etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
Other Name: etomidate, fentanyl, and lidocaine

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 13, 2014
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:
Etomidate
Fentanyl
Ketamine
Lidocaine
Midazolam
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Anxiety Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014