Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Peter Winch

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Drug: Acetaminophen

Study type: Observational

Funder types: Other

Identifiers

NCT04278625

STUDY00000766

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Cyanotic CHD

Description:

Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.

Treatment:

Drug: Acetaminophen

Acyanotic CHD

Description:

Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.

Treatment:

Drug: Acetaminophen