Status:

COMPLETED

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Lead Sponsor:

Peter Winch

Conditions:

Congenital Heart Disease

Eligibility:

All Genders

2-6 years

Brief Summary

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 acet...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 23 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 16 2022

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04278625

Start Date

March 23 2021

End Date

February 16 2022

Last Update

April 29 2024

Active Locations (1)

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1

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205