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NCT00596050 · ClinicalTrials.gov registry record · Phase 4
Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
A Phase 4 study of Conscious Sedation Failure During Procedure, sponsored by Drexel University College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00596050: Completed Phase 4 study of Conscious Sedation Failure During Procedure, sponsored by Drexel University College of Medicine.
NCT00596050 is a Phase 4 study of Conscious Sedation Failure During Procedure that has completed, run by Drexel University College of Medicine. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00596050, a Phase 4 study of Conscious Sedation Failure During Procedure, has completed, sponsored by Drexel University College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG ketamine and midazolam
- DRUG etomidate, fentanyl, and lidocaine
Study Locations (1)
Pennsylvania
- St. Christopher's Hospital for Children - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00596050 record still lists
NCT00596050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Conscious Sedation Failure During Procedure appearing as the primary indexed condition, and to 2 interventions - of which ketamine and midazolam is the first listed.
NCT00596050 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00596050 about?
NCT00596050 is a clinical study titled "Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions". 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 i...
What is the current status of trial NCT00596050?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2006-08. Estimated completion is 2008-06.
What conditions does trial NCT00596050 study?
This clinical trial studies the following conditions: Conscious Sedation Failure During Procedure.
What interventions are being tested in trial NCT00596050?
The interventions under investigation include: ketamine and midazolam (DRUG), etomidate, fentanyl, and lidocaine (DRUG).
Who is sponsoring clinical trial NCT00596050?
This trial is sponsored by Drexel University College of Medicine, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00596050 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00596050's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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