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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2008

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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Philadelphia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Athena Zuppa, MD, MSCE, Principal Investigator, Children’s Hospital of Philadelphia

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