Heart Disease Clinical Trial
Official title:
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
The study will be a prospective study of plasma concentrations after intranasal (1 µg/kg and
2µg/kg) and intravenous (1 µg /kg) DEX to determine the early pharmacokinetics (maximum
concentration (peak) and time to peak) and bioavailability of a single intranasal dose in
pediatric patients.
Dexmedetomidine sedation is commonly utilized at Cincinnati Children's Medical Center (CCHMC)
and other pediatric institutions. This compound is delivered intravenously or intranasally
for sedation in children with and without congenital heart disease. Intranasal DEX, though
very effective for sedation, has significant variability in its onset and peak effect.
Patient care will be significantly improved if factors that determine this variability in
onset and peak effect can be determined. Investigators will determine the important early
clinical variables of peak plasma DEX concentration (Tmax and Cmax) and the 0 - 2 hour
bioavailability of intranasal DEX in children.
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