Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery
This medication is used for procedural sedation and sedation for diagnostic imaging. The purpose of this study is to find out what happens to pentobarbital in the body after it is given to children who have had heart surgery.
Cardiac Surgical Procedures
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Pharmacokinetics and Pharmacodynamics of a Single Dose of Pentobarbital for Clinically Indicated Sedation for Neonates, Infants, and Children Recovering From Open Heart Surgery|
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||December 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
This clinical trial of pentobarbital admistered as a bolus dose for procedural or imaging seddation will determine the PK of the drug in neonates, infants,, and children who are postoperative from cardiac surgery. Pediatric patients hsopitalized in the CICU who would receive IV bolus doses of pentobarbital as standard of care are eligible.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577434
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Athena Zuppa, MD, MSCE||Children's Hospital of Philadelphia|