Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, population pharmacokinetics, paediatrics
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALTitration of paracetamol and its metabolites - scheme1
15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol
BIOLOGICALTitration of paracetamol and its metabolites - scheme 2
30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol | 2 hours | The overall concentrations (parent drug and metabolites) have the same unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gamma-Glutamyl transpeptidase (UI/L) | 24 hours | Liver function tests |
| Alkaline Phosphatase PALK (UI/L) | 24 hours | Liver function tests |
| Bilirubin (μmol/L) | 24hours | Liver function tests |
| Aspartate aminotransferase (ASAT) (UI/L) | 24 hours | Liver function tests |
| Alanine aminotransferase (ALAT) (UI/L) | 24 hours | Liver function tests |
Countries
France
Contacts
Primary ContactFlorentia KAGUELIDOU, MD, PhD
Backup ContactKarima MESBAHI-IHADJADENE, Project manager
Outcome results
None listed