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NCT04278625 Clinical Trial

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04278625
Other study ID # STUDY00000766
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2021
Est. completion date February 16, 2022

Study information
Verified date November 2023
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 16, 2022
Est. primary completion date February 16, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 6 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Acetaminophen
IV acetaminophen given as part of standard of care.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Peter Winch

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acetaminophen Serum Concentrations The amount of acetaminophen in the blood stream at each time point after receiving a standard dose. 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration
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