CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
ketamine and midazolam +1 moredrug
Likely dose
ketamine and midazolam 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00596050
NCT00596050Phase 4Completed

Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Drexel University College of Medicine·interventional·Posted Jan 16, 2008·Updated May 9, 2017

In Brief

A Phase 4 clinical trial evaluating ketamine and midazolam and etomidate, fentanyl, and lidocaine for Conscious Sedation Failure During Procedure. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2008
Enrollment StartAug 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.5 years ago

Interventions

ketamine and midazolamdrug

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

etomidate, fentanyl, and lidocainedrug

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