How paracetamol moves through the bodies of overweight and obese children
Studies how paracetamol is processed in children aged 6 to 17 with excess weight.
Plain-language title generated from the registry record
Registry title: Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
Key facts
- Where
- Paris, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT06135389, who can take part
Where in France
- Robert Debre University HospitalParis, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06135389
- Record updated
- 20 January 2025
- Original description
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.Read full original descriptionShow less
Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
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.
Inclusion: 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: 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; 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).