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Keep this study
Lead
Children's Hospital Medical Center, Cincinnati
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.
Age
0–4
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
