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Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

NCT00596050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-05-09

No results posted yet for this study

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.

Conditions

  • Conscious Sedation Failure During Procedure

Interventions

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

Sponsors & Collaborators

  • Drexel University College of Medicine

    lead OTHER

Principal Investigators

  • Jannet J Lee-Jayaram, M.D. · Drexel University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596050 on ClinicalTrials.gov