N/A
N=30
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT04278625 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Acetaminophen Serum Concentrations — 19; 17; 13; 13 mcg/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Acetaminophen (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Peter Winch
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acetaminophen Serum Concentrations |
19; 17; 13; 13; 11; 10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04278625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.