Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery

Stopped early

Conditions studied: Cardiac Surgical Procedures

In brief

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.

Key facts

Study ID

NCT00577434

Run by

Children's Hospital of Philadelphia

People needed

37

Starts

2006-04-01

Expected to finish

2008-12-01

Last updated by the study team

2015-03-12

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Informed consent

You may not qualify if…

• Pregnant or lactating females
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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