Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Phase 4

Completed

• Conditions: Conscious Sedation Failure During Procedure
• Interventions: Drug: ketamine and midazolam; Drug: etomidate, fentanyl, and lidocaine

• Registration Number: NCT00596050
• Lead Sponsor: Drexel University College of Medicine

Brief 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine and midazolam	ketamine and midazolam	ketamine and midazolam
etomidate and fentanyl and lidocaine	etomidate, fentanyl, and lidocaine	etomidate and fentanyl and lidocaine

Primary Outcome Measures

Name	Time	Method
OSBD-r	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 Outcome Measures

Name	Time	Method
Likert satisfaction scale	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.
procedural recall	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.

Trial Locations

Locations (1)

St. Christopher's Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States