drugset / Trial / NCT03417999
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Non-randomizedSequentialOpen-labelOther
Summary
The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.
Timeline
- Start
- 2018-06-14
- Primary completion
- 2021-10-12
- Completion
- 2021-10-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 2 ug/kg | Intranasal |
| Subject | Dexmedetomidine | Other / unclassified | 4 ug/kg | Intranasal |