Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery
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ClinicalTrials.gov Identifier: NCT00577434
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.
Condition or disease
Cardiac Surgical Procedures
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.
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Ages Eligible for Study:
up to 6 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All patients enrolled in this study will be postoperative from cardiac surgery adn have require sedation for a procedure or diagnostic imaging.
Will receive intravenous pentobarbital for procedural/imaging sedation as standard of care
Age(Neonates, Young Infants, Older Infants, and Children Up to 6 years old)
Diagnosis either postop from cardiac surgery or requrie sedation with IV pentobarbital as standard of care
Adequate liver function tests
Pregnant or lactating females
Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.