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

Children's Hospital of Philadelphia (CHOP)

Status: Terminated

Conditions: Cardiac Surgical Procedures

Study type: Observational

Funder types: Other

Identifiers

NCT00577434

CTRC 2012

2006-4-4822

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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