NCT02836431

Pharmacokinetic Study of Dexmedetomidine After Intra-nasal 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 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

Interventions

Type	Name	Description
DRUG	Dexmedetomidine 1mcg/kg Intranasal	DEX 1 mcg/kg Intranasal
DRUG	Dexmedetomidine 2mcg/kg Intranasal	DEX 2 mcg/kg Intranasal
DRUG	Dexmedetomidine 1mcg Intravenous	DEX 1 mcg/kg Intravenously

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2016-07-19
• Last updated: 2018-07-30

Locations

1 site across 1 country: United States