NCT00577434

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 12, 2015

Status Verified

July 1, 2008

Enrollment Period

2.2 years

First QC Date

December 18, 2007

Last Update Submit

March 11, 2015

Conditions

Cardiac Surgical Procedures

Keywords

Procedural sedationSedation for diagnostic imaging

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating females
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: NONE RETAINED

Blood

Study Officials

  • Athena Zuppa, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

April 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

March 12, 2015

Record last verified: 2008-07

Locations

US(1)