Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Ketamine

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.

Intervention / Treatment

  • Drug: Ketamine and Midazolam
  • Drug: etomidate, fentanyl, and lidocaine

Condition or Disease

  • Conscious Sedation Failure During Procedure

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 5 Years to 18 Years   (Child, Adult)
Enrollment: 50 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Aug 06, 2020
Primary Completion: Jun 08, 2020
Completion Date: Jun 08, 2020
Study First Posted: Jan 16, 2008
Results First Posted: Aug 31, 2020
Last Updated: May 09, 2017

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Philadelphia, Pennsylvania, USA

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.

Eligibility Criteria

Sex: All
Minimum Age: 5
Maximum Age: 18

More Details

NCT Number: NCT00596050
Other IDs: 16271|Project No 1041266|Action No 47488|Detail No 240976
Study URL: https://ClinicalTrials.gov/show/NCT00596050
Last updated: Jun 17, 2022