Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Peter Winch30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Heart Disease

Interventions

AcetaminophenDRUG

IV acetaminophen given as part of standard of care.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Acetaminophen Serum Concentrations

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

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

Data from ClinicalTrials.gov

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