NCT00459082

A Pharmacokinetic Study of Dexmedetomine in Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (planned)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.

Detailed description

This clinical trial of three dose rates of dexmedetomine will determine the pharmacokinetics of the drug in infants who remain tracheally intubated postoperatively. An exploratory pharmacodynamic study of a non-invasive device measuring sedation will be performed. Although the pharmacokinetics of dexmedetomine have been described for pediatric patients, the drug disposition in infants has not been well described. A range of doses has been studied, yet there are no reports describing the optimal dose for post-operative pediatric patients. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Conditions

• Cardiac Surgical Procedures

Interventions

Type	Name	Description
DRUG	Dexmedetomine

Timeline

• Start date: 2004-05-01
• Completion: 2006-11-01
• First posted: 2007-04-11
• Last updated: 2007-04-11

Locations

1 site across 1 country: United States