Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

NCT ID: NCT02836431

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-04-30

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.

Conditions

Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

DEX 1 mcg/kg Intranasal

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.

Group Type: EXPERIMENTAL

Dexmedetomidine 1mcg/kg Intranasal

Intervention Type: DRUG

DEX 1 mcg/kg Intranasal

DEX 2 mcg/kg Intranasal

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.

Group Type: EXPERIMENTAL

Dexmedetomidine 2mcg/kg Intranasal

Intervention Type: DRUG

DEX 2 mcg/kg Intranasal

DEX 1 mcg/kg Intravenous

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.

Group Type: EXPERIMENTAL

Dexmedetomidine 1mcg Intravenous

Intervention Type: DRUG

DEX 1 mcg/kg Intravenously

Interventions

Dexmedetomidine 1mcg/kg Intranasal

DEX 1 mcg/kg Intranasal

Intervention Type: DRUG

Dexmedetomidine 2mcg/kg Intranasal

DEX 2 mcg/kg Intranasal

Intervention Type: DRUG

Dexmedetomidine 1mcg Intravenous

DEX 1 mcg/kg Intravenously

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2015-5966

Identifier Type: -

Identifier Source: org_study_id