CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Acetaminophendrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04278625
NCT04278625N/ACompleted
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Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Peter Winch·observational·Posted Feb 20, 2020·Updated Apr 29, 2024

In Brief

An observational study evaluating Acetaminophen for Congenital Heart Disease. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 20, 2020
Enrollment StartMar 23, 2021
Primary CompletionFeb 16, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.4 years ago

Interventions

Acetaminophendrug

IV acetaminophen given as part of standard of care.