Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children

The study will be a prospective study of plasma concentrations after intranasal or buccal DEX
to determine the early pharmacokinetics and bioavailability of a single dose via nasal or
oral administration.

Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other
pediatric institutions. This compound is typically delivered intravenously or intranasally
for sedation in children with or without congenital heart disease. Intranasal DEX is very
effective for sedation although it has significant variability in the onset and peak effect.
Patient care will be improved if factors that determine this variability can be determined.
Investigators will determine the important clinical variables of peak plasma DEX
concentration (Tmax and Cmax) of intranasal and buccal DEX in children.

Inclusion Criteria:

- Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective
cardiac surgery

- The subject must be a candidate to receive Dex as determined by one of the study
cardiac anesthesiologists

- The attending cardiac anesthesiologists for the case and the Chief of Anesthesia
Cardiac Anesthesia will concur with or veto this decision

- The subjects legally authorized representative has given written informed consent to
participate in the study

Exclusion Criteria:

- Post-natal age less than 6 months

- The subject is allergic to or has had a contraindication to Dex

- Severely depressed ventricular function on preoperative echocardiogram

- The subject has a high risk of cardiac conduction system disease in the judgement of
the attending anesthesiologist or cardiologist

- The subject has a hemodynamically significant aortic coarctation or other left heart
outflow obstruction

- The subject has received digoxin, beta-adrenergic antagonist, or calcium channel
antagonist on the day of surgery

- The subject has received Dex within 1 week of the study date

- Patients who are to receive intranasal Dex are excluded if they have nasal/respiratory
symptoms, which in the opinion of the study anesthesiologist, may affect intranasal
drug absorption