Clinical trial NCT03668951: Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
Official title: Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Diseases
Keywords: Pediatric
Sedation
Dexmedetomidine
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum blood concentration level of Dex - Cmax
timeFrame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
measure: The amount of time that Dex is present at the maximum concentration - Tmax
timeFrame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
Secondary outcomes:
measure: Area under the curve for Dex concentration levels
timeFrame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
measure: Bioavailability of intranasal Dex relative to intravenous Dex for distribution - plasma concentration
timeFrame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
measure: Bioavailability of IN Dex relative to intravenous Dex for elimination - plasma concentration.
timeFrame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
measure: Adverse events associated with Dex administration
timeFrame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
measure: Systolic and diastolic blood pressure with Dex administration
timeFrame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Joanna Paquin
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jayant Pratap, MA,MB BChir,MRCPCH,FRCA
role: PRINCIPAL_INVESTIGATOR
References: