Clinical trial NCT02836431: Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
Official title: Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Disease
Keywords: Pediatric
Sedation
Dexmedetomidine
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-07-19
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 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.

Detailed description: 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.

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. A physician member of the Division of Cardiac Anesthesiology, not involved in the study, will make this decision.
* The subject's legally authorized representative has given written informed consent to participate in the study.

Exclusion Criteria:

* Post-natal age (PNA) \< 6 months
* The subject is allergic to or has a contraindication to DEX
* Severely depressed ventricular function (ejection fraction 30% or less) on preoperative echocardiogram
* The subject has high risk cardiac conduction system disease at the discretion of the attending anesthesiologist or cardiologist.
* The subject has a hemodynamically significant coarctation or other left heart outflow obstruction
* The subject has received digoxin, beta-adrenergic antagonist, or calcium-channel antagonist on the day of the study
* The subject has received DEX within 1 week of the study date (information obtained from: parent or Medical record)
* Subject have nasal/respiratory symptoms which in the opinion of the Principal investigator, may affect intranasal drug absorption.

Primary outcomes:
measure: Maximum blood concentration level of DEX - Cmax
timeFrame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
measure: The amount of time that a DEX is present at the maximum concentration - Tmax
timeFrame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
measure: Area under the curve for DEX concentration levels
timeFrame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
measure: Bioavailability of intranasal DEX relative to intravenous DEX for distribution - plasma concentration
timeFrame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
measure: Bioavailability of intranasal DEX relative to intravenous DEX for elimination - plasma concentration
timeFrame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Secondary outcomes:
measure: Adverse events associated 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: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jeff Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: