Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease
• Interventions: Drug: Acetaminophen

• Registration Number: NCT04278625
• Lead Sponsor: Peter Winch

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Study Start: 2021-03-23
• Primary Completion: 2022-02-16
• Study Completion: 2022-02-16
• Status Verified: 2023-11
• Results First Submitted: 2023-11-15
• Results First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Results First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acyanotic CHD	Acetaminophen	Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
Cyanotic CHD	Acetaminophen	Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.

Primary Outcome Measures

Name	Time	Method
Acetaminophen Serum Concentrations	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States