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

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

July 14, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00577434 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Pharmacokinetics and Pharmacodynamics of a Single Dose of Pentobarbital for Clinically Indicated Sedation for Neonates, Infants, and Children Recovering From Open Heart Surgery

Brief 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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Cardiac Surgical Procedures

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00577434

Responsible Party

Athena Zuppa, MD, The Children's Hospital of Philadelphia

Study ID Numbers ^ICMJE

2006-4-4822, CTRC 2012

Study Sponsor ^ICMJE

Children's Hospital of Philadelphia

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Athena Zuppa, MD, MSCE

Children's Hospital of Philadelphia

Information Provided By

Children's Hospital of Philadelphia

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP