Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-20 @ 12:30 PM
Study NCT ID:
NCT00596050
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2008-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Sponsor:
Drexel University College of Medicine
Organization:
Study Overview
Official Title:
Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: