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Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

NCT04278625 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-04-29

Study results available
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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.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

Acetaminophen

IV acetaminophen given as part of standard of care.

Sponsors & Collaborators

  • Peter Winch

    lead OTHER

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-02-16
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04278625 on ClinicalTrials.gov