Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

Cincinnati Children's Hospital Medical Center

Status and phase

Completed

Phase 1

Conditions

Heart Disease

Treatments

Drug: Dexmedetomidine 1mcg Intravenous

Drug: Dexmedetomidine 1mcg/kg Intranasal

Drug: Dexmedetomidine 2mcg/kg Intranasal

Study type

Interventional

Funder types

Other

Identifiers

NCT02836431

2015-5966

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

6 to 48 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 3 patient groups

DEX 1 mcg/kg Intranasal

Experimental group

Description:

Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia , placement of an endotracheal tube and an arterial line. Once these are accomplished, dexmedetomidine is administered according to group assignment.

Treatment:

Drug: Dexmedetomidine 1mcg/kg Intranasal

DEX 2 mcg/kg Intranasal

Experimental group

Description:

Treatment:

Drug: Dexmedetomidine 2mcg/kg Intranasal

DEX 1 mcg/kg Intravenous

Experimental group

Description:

Treatment:

Drug: Dexmedetomidine 1mcg Intravenous