Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery
Information source: Children's Hospital of Philadelphia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgical Procedures
Phase: N/A
Status: Recruiting
Sponsored by: Children's Hospital of Philadelphia Official(s) and/or principal investigator(s):
Athena Zuppa, MD, MSCE, Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Overall contact:
Mary Ann DiLiberto, BS, RN, Phone: 267.426.5753, Email: diliberto@email.chop.edu
Summary
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.
Clinical Details
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 design: Cohort, Prospective
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mary Ann DiLiberto, BS, RN, Phone: 267.426.5753, Email: diliberto@email.chop.edu
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Athena Zuppa, MD, MSCE, Principal Investigator
Additional Information
Starting date: April 2006
Ending date: April 2008
Last updated: December 18, 2007
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