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OpenTrials
Completed

NCT Number: NCT04278625

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting for Fontan palliation or for surgical repair requiring median sternotomy, will be included in the study.
  • Only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn.

Exclusion criteria

  • Documentation of an allergy to acetaminophen
  • Severe hepatic disease or other contraindications to acetaminophen use
  • Patient has received acetaminophen within 24 hours of their procedure

Treatment and study plan

Acetaminophen

Drug

IV acetaminophen given as part of standard of care.

Primary outcomes

  1. Acetaminophen Serum Concentrations

    Time frame: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration

    The amount of acetaminophen in the blood stream at each time point after receiving a standard dose.

Sponsors and collaborators

Lead sponsor

Peter Winch

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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