NCT00596050

Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Drexel University College of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Conscious Sedation Failure During Procedure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-01-16
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States