Population Pharmacokinetics of Paracetamol in Overweight and Obese Children

Not yet recruiting

• Conditions: Obesity; Overweight
• Interventions: Biological: Titration of paracetamol and its metabolites - scheme1; Biological: Titration of paracetamol and its metabolites - scheme 2

• Registration Number: NCT06135389
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Status Verified: 2024-01
• Study Start: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
blood sampling scheme1	Titration of paracetamol and its metabolites - scheme1	3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1
blood sampling scheme2	Titration of paracetamol and its metabolites - scheme 2	3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Alkaline Phosphatase PALK (UI/L)	24 hours	Liver function tests
Bilirubin (μmol/L)	24hours	Liver function tests
Gamma-Glutamyl transpeptidase (UI/L)	24 hours	Liver function tests
Aspartate aminotransferase (ASAT) (UI/L)	24 hours	Liver function tests
Alanine aminotransferase (ALAT) (UI/L)	24 hours	Liver function tests

Trial Locations

Locations (1)

Robert Debré University Hospital; 🇫🇷 Paris, France