NCT03668951

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 6 Months – 48 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dexmedetomidine buccal	DEX 2 mcg/kg buccal
DRUG	Dexmedetomidine Intranasal	DEX 3 mcg/kg intranasal
DRUG	Dexmedetomidine Intranasal	DEX 4 mcg/kg intranasal

Timeline

• Start date: 2018-08-20
• Primary completion: 2022-05-03
• Completion: 2022-05-03
• First posted: 2018-09-13
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study