drugset / Trial / NCT03417999

Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

NCT03417999

Phase 1 Terminated 28 enrolled Children's Hospital of Philadelphia
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

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 2 ug/kg Intranasal
Subject Dexmedetomidine Other / unclassified 4 ug/kg Intranasal