NCT04027829

Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

Pharmacokinetic-pharmacodynamic Analysis for Dosing Strategy and Evaluation of Safety and Efficacy of Dexmedetomidine in Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.

Detailed description

Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.

Conditions

• Intensive Care Unit
• Postoperative Care

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Hydrochloride	Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.

Timeline

• Start date: 2019-08-14
• Primary completion: 2019-11-14
• Completion: 2019-11-14
• First posted: 2019-07-22
• Last updated: 2020-04-14

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study