Population Pharmacokinetics of Paracetamol in Overweight and Obese Children

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes paracetamol (a common pain reliever) in overweight and obese children compared to those with normal weight. The researchers want to understand how factors like weight and age affect how well children can metabolize this medication, especially when it's given through an injection after surgery. This information could help doctors prescribe the right dose of paracetamol for children of different sizes.

To be eligible for this study, children aged 6 to 17 who are either normal weight, overweight, or obese can participate if they need paracetamol for pain relief after surgery. However, children with certain health issues, such as liver problems, diabetes, or those who have taken paracetamol recently, won’t be able to join. Participants can expect to receive the medication and have their responses monitored to gather important information. This study is still in the planning phase and hasn’t started recruiting participants yet.

Gender

ALL

Eligibility 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