Clinical trial

Population Pharmacokinetics of Paracetamol in Overweight and Obese Children

Opening soon · Not applicable · 1 countries · Registry ID NCT06135389

Opening soonNot applicableObservational

What this study is about

The main objective of the study is to define population pharmacokinetic parameters and variability factors for paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 17 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity

Full registry criteria

Inclusion Criteria: * Child aged 6 to 17 inclusive with normal weight for age and gender (body mass index \[BMI\]\<25kg/m2 adult equivalent at 18 years \[IOTF 25\]), overweight (body mass index \[BMI\]≥ 25kg/m2 adult equivalent at age 18 \[IOTF 25\] and obese (BMI ≥ 30kg/m2 adult equivalent at age 18 \[IOTF 30\]) for age and sex * Surgical procedure requiring treatment with paracetamol intravenously as an analgesic * No opposition by the holder(s) of parental authority Exclusion Criteria: * History of chronic anaemia (≤ 5g/100ml) * History of hepatocellular insufficiency (ASAT, ALAT ≥ 3N) * History of renal impairment (\<60mL/min\*1.73m2) * History of Gilbert's disease * History of Type 2 diabetes * Major motor or neurological disability * Intake of paracetamol within 24 hours before study inclusion (injection of paracetamol IV or oral intake) * Patients treated with medicinal products known to affect CYP2E1 or UGT (UDP glucuronosyltransferase): isoniazid, antiepileptic drugs (carbamazepine, phenytoin or phenobarbital), antiretroviral and tyrosine kinase inhibitors

Treatments and study arms

Titration of paracetamol and its metabolites - scheme1

Biological

15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol

Titration of paracetamol and its metabolites - scheme 2

Biological

30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)

Primary outcomes

Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol2 hours

The overall concentrations (parent drug and metabolites) have the same unit

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Robert Debré University Hospital🇫🇷 Paris, France
Florentia KAGUELIDOU, MD, PhDContact