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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00577434
Recruitment Status : Terminated (Sluggish enrollment)
First Posted : December 20, 2007
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease
Cardiac Surgical Procedures

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 Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: 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
Study Start Date : April 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00577434

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Principal Investigator: Athena Zuppa, MD, MSCE Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT00577434     History of Changes
Other Study ID Numbers: 2006-4-4822
CTRC 2012
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: July 2008

Keywords provided by Children's Hospital of Philadelphia:
Procedural sedation
Sedation for diagnostic imaging

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action