Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-23

Study Completion Date

2022-02-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cyanotic CHD

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

Acetaminophen

Intervention Type DRUG

IV acetaminophen given as part of standard of care.

Acyanotic CHD

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

Acetaminophen

Intervention Type DRUG

IV acetaminophen given as part of standard of care.

Interventions

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Acetaminophen

IV acetaminophen given as part of standard of care.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No