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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00577434 |
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 |
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Cardiac Surgical Procedures |
Study Type: | Observational |
Study Design: | Cohort, 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 |
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) |
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.
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
All patients enrolled in this study will be postoperative from cardiac surgery adn have require sedation for a procedure or diagnostic imaging.
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Athena Zuppa, MD, MSCE | Children's Hospital of Philadelphia |
Responsible Party: | The Children's Hospital of Philadelphia ( Athena Zuppa, MD ) |
Study ID Numbers: | 2006-4-4822, CTRC 2012 |
Study First Received: | December 18, 2007 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00577434 |
Health Authority: | United States: Institutional Review Board |
Procedural sedation Sedation for diagnostic imaging |
Pentobarbital |
Adjuvants, Anesthesia Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Therapeutic Uses Physiological Effects of Drugs |
Hypnotics and Sedatives GABA Agents Central Nervous System Depressants Central Nervous System Agents Pharmacologic Actions |