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

Cardiac Surgical Procedures Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577434
• Other study ID #: 2006-4-4822
• Secondary ID: CTRC 2012
• Status: Terminated
• Phase: N/A
• First received: December 18, 2007
• Last updated: March 11, 2015
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2008
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States,