Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459082
Status:
COMPLETED
Last Update Posted:
2007-04-11
First Post:
2007-04-09
Brief Title:
A Pharmacokinetic Study of Dexmedetomine in Infants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
A Pharmacokinetic Study of Dexmedetomine in Infants
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None