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.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Started
- Mar 2025
- Planned end
- Mar 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Titration of paracetamol and its metabolites - scheme1
- Titration of paracetamol and its metabolites - scheme 2
- Record updated
- 20 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 6 to 17 who are normal weight, overweight or obese and need surgery with intravenous paracetamol for pain relief.
- Age
- 6 to 17 years
- Sex
- All sexes
- Disease stage
- Weight for age and sex: normal weight (BMI under 25 kg/m2 adult equivalent at 18), overweight (BMI 25 or more) or obese (BMI 30 or more).
- Earlier treatment
- Must not have taken paracetamol (by injection or by mouth) in the 24 hours before joining. Must not be treated with drugs that affect CYP2E1 or UGT.
Main reasons for not taking part
- History of long-lasting anaemia
- History of liver problems (ASAT or ALAT 3N or more)
- History of kidney problems (below 60 mL/min*1.73m2)
- History of Gilbert's disease or type 2 diabetes
- Major movement or nerve disability
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Check if you might fit
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?
Where in France
- Robert Debre University HospitalParis, FranceContact: Florentia KAGUELIDOU, MD, PhDNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- blood sampling scheme1
3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1
Treatment: Titration of paracetamol and its metabolites - scheme1
- blood sampling scheme2
3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2
Treatment: Titration of paracetamol and its metabolites - scheme 2
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
- Plain-language title
- How paracetamol moves through the bodies of overweight and obese childrenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06135389, who can take part
- Record updated
- 20 January 2025