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Completed

NCT Number: NCT00596050

Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

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.

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Key information

Conditions

Conscious Sedation Failure During Procedure Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine and Midazolam

Drug

ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg

etomidate, fentanyl, and lidocaine

Drug

etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Drexel University College of Medicine

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 16, 2008
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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