Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children

NCT ID: NCT03668951

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2022-05-03

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.

Conditions

Heart Diseases

Study Design

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

Study Groups

Buccal DEX 2 mcg/kg

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 buccal

Intervention Type: DRUG

DEX 2 mcg/kg buccal

Intranasal DEX 3 mcg/kg

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 Intranasal

Intervention Type: DRUG

DEX 3 mcg/kg intranasal

Intranasal DEX 4 mcg/kg

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 Intranasal

Intervention Type: DRUG

DEX 4 mcg/kg intranasal

Interventions

Dexmedetomidine buccal

DEX 2 mcg/kg buccal

Intervention Type: DRUG

Dexmedetomidine Intranasal

DEX 3 mcg/kg intranasal

Intervention Type: DRUG

Dexmedetomidine Intranasal

DEX 4 mcg/kg intranasal

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 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

• 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

Jayant Pratap, MA,MB BChir,MRCPCH,FRCA

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Joanna Paquin

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2018-3034

Identifier Type: -

Identifier Source: org_study_id