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

This study has been terminated.

Sponsored by:	Children's Hospital of Philadelphia
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00577434

Purpose

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
Cardiac Surgical Procedures

MedlinePlus related topics: Heart Surgery

Drug Information available for: Pentobarbital Pentobarbital sodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Further study details as provided by Children's Hospital of Philadelphia:

Biospecimen Retention: None Retained

Biospecimen Description:

Blood

Enrollment:	37
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	up to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All patients enrolled in this study will be postoperative from cardiac surgery adn have require sedation for a procedure or diagnostic imaging.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577434

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator:

Athena Zuppa, MD, MSCE

Children's Hospital of Philadelphia

More Information

Responsible Party:	The Children's Hospital of Philadelphia ( Athena Zuppa, MD )
Study ID Numbers:	2006-4-4822, CTRC 2012
Study First Received:	December 18, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00577434
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

Procedural sedation
Sedation for diagnostic imaging

Study placed in the following topic categories:

Pentobarbital

Additional relevant MeSH terms:

Adjuvants, Anesthesia
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Therapeutic Uses
Physiological Effects of Drugs

Hypnotics and Sedatives
GABA Agents
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009