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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00577434

Enrollment

Registered

2007-12-20

Start date

2006-04-30

Completion date

2008-12-31

Last updated

2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures

Keywords

Procedural sedation, Sedation for diagnostic imaging

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

Healthy volunteers

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.

Countries

United States

Outcome results