drugset / Trial / NCT01519167
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
NaSingle-groupOpen-labelTreatment
Summary
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.
Timeline
- Start
- 2012-10
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.6 ug/kg | Intravenous |
| Background | Fentanyl | Other / unclassified | 0.5 ug/kg | Intravenous |
| Background | Fentanyl | Other / unclassified | 3 ug/kg | Intravenous |
| Background | Midazolam | Small molecule | 0.025 mg/kg | Intravenous |
| Background | Midazolam | Small molecule | 2 mg/kg | Intravenous |