Population Pharmacokinetics of Paracetamol in Overweight and Obese Children (PARAENFO)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Overweight; Obesity

Treatments: Biological: Titration of paracetamol and its metabolites - scheme1; Biological: Titration of paracetamol and its metabolites - scheme 2

Study type: Observational

Funder types: Other

Identifiers

NCT06135389

2022-A01743-40 (Registry Identifier)

APHP 201129

Details and patient eligibility

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.

Full description

This study will determine the pharmacokinetic parameters of paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex. The results will enable establishing dosage recommendations for paracetamol in overweight and/or obese children and adolescents.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

blood sampling scheme1

Description:

3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1

Treatment:

Biological: Titration of paracetamol and its metabolites - scheme1

blood sampling scheme2

Description:

3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2

Treatment:

Biological: Titration of paracetamol and its metabolites - scheme 2