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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

NCT01501786

Congenital Heart Disease Sedated for Cardiac Catheterization

COMPLETED NA

Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old

NCT02221674

Moderate to Severe Acute Postoperative Pain

TERMINATED PHASE2

Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures

NCT04350528

Children Sedation

UNKNOWN

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

NCT01431326

Adenovirus Anesthesia Anxiety +56 more

COMPLETED

Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

NCT03059511

Pharmacokinetic

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgical Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No