Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Source Children's Hospital Medical Center, Cincinnati
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.

Overall Status Completed
Start Date January 2016
Completion Date April 2018
Primary Completion Date December 2017
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Maximum blood concentration level of DEX - Cmax Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
The amount of time that a DEX is present at the maximum concentration - Tmax Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Area under the curve for DEX concentration levels Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Bioavailability of intranasal DEX relative to intravenous DEX for distribution - plasma concentration Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Bioavailability of intranasal DEX relative to intravenous DEX for elimination - plasma concentration Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Secondary Outcome
Measure Time Frame
Adverse events associated with DEX administration Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
Enrollment 18
Condition
Intervention

Intervention type: Drug

Intervention name: Dexmedetomidine 1mcg/kg Intranasal

Description: DEX 1 mcg/kg Intranasal

Arm group label: DEX 1 mcg/kg Intranasal

Intervention type: Drug

Intervention name: Dexmedetomidine 2mcg/kg Intranasal

Description: DEX 2 mcg/kg Intranasal

Arm group label: DEX 2 mcg/kg Intranasal

Intervention type: Drug

Intervention name: Dexmedetomidine 1mcg Intravenous

Description: DEX 1 mcg/kg Intravenously

Arm group label: DEX 1 mcg/kg Intravenous

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.

Gender: All

Minimum age: 6 Months

Maximum age: 48 Months

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jeff Miller, MD Principal Investigator Children's Hospital Medical Center, Cincinnati
Location
facility Cincinnati Children's Hospital Medical Center
Location Countries

United States

Verification Date

July 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: DEX 1 mcg/kg Intranasal

Arm group type: Experimental

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.

Arm group label: DEX 2 mcg/kg Intranasal

Arm group type: Experimental

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.

Arm group label: DEX 1 mcg/kg Intravenous

Arm group type: Experimental

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.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov