Trials / Completed
CompletedNCT04278625
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Peter Winch · Academic / Other
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen | IV acetaminophen given as part of standard of care. |
Timeline
- Start date
- 2021-03-23
- Primary completion
- 2022-02-16
- Completion
- 2022-02-16
- First posted
- 2020-02-20
- Last updated
- 2024-04-29
- Results posted
- 2024-04-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04278625. Inclusion in this directory is not an endorsement.