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

This study has been terminated.
(Sluggish enrollment)
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00577434
First received: December 18, 2007
Last updated: July 14, 2008
Last verified: July 2008
History of Changes
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

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

Biospecimen Retention:   None Retained

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 23, 2013