OverweightPARAENFONCT06135389
Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
An observational study of Overweight and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Titration of paracetamol and its metabolites - scheme1 and Titration of paracetamol and its metabolites - scheme 2
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Non-obese, overweight and obese children aged 6 to 17 scheduled for surgery requiring intravenous (IV) paracetamol injection intraoperatively.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Robert Debré University Hospital
Paris, 75019
Florentia KAGUELIDOU, MD, PhD, +33 1 40 03 41 42, florentia.kaguelidou@aphp.fr
About this study
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 the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Titration of paracetamol and its metabolites - scheme1, Titration of paracetamol and its metabolites - scheme 2
- Keywords
- Obesity, Overweight, population pharmacokinetics, paediatrics
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of paracetamol and its metabolites - scheme1Biological
15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol
Titration of paracetamol and its metabolites - scheme 2Biological
30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)
| Study group | Role | What they receive |
|---|---|---|
| blood sampling scheme1 | 3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1 Receives: Biological: 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 Receives: Biological: Titration of paracetamol and its metabolites - scheme 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol
The overall concentrations (parent drug and metabolites) have the same unit
Measured: 2 hours
Secondary outcomes (5)
Aspartate aminotransferase (ASAT) (UI/L)
Liver function tests
Measured: 24 hours
Alanine aminotransferase (ALAT) (UI/L)
Liver function tests
Measured: 24 hours
Alkaline Phosphatase PALK (UI/L)
Liver function tests
Measured: 24 hours
Bilirubin (μmol/L)
Liver function tests
Measured: 24hours
Gamma-Glutamyl transpeptidase (UI/L)
Liver function tests
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sihem BENABOUD, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135389
- Sponsor's protocol ID
- APHP 201129
- Other IDs
- 2022-A01743-40
- Acronym
- PARAENFO
- Status last verified
- Jan 2025
- First submitted
- 12 Jul 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
- ClinicalTrials.gov ID
- NCT06135389
- Acronym / sponsor ID
- PARAENFO / APHP 201129
- Conditions
- Overweight, Obesity
- Keywords
- Obesity, Overweight, population pharmacokinetics, paediatrics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood sampling scheme1 | – | Biological: Titration of paracetamol and its metabolites - scheme13 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1 |
| blood sampling scheme2 | – | Biological: Titration of paracetamol and its metabolites - scheme 23 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Non-obese, overweight and obese children aged 6 to 17 scheduled for surgery requiring intravenous (IV) paracetamol injection intraoperatively.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration of paracetamol and its metabolites - scheme115 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol | Biological | blood sampling scheme1 |
| Titration of paracetamol and its metabolites - scheme 230 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration) | Biological | blood sampling scheme2 |
Primary outcome
Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol
Time frame: 2 hours
The overall concentrations (parent drug and metabolites) have the same unit
5 secondary outcomes
Aspartate aminotransferase (ASAT) (UI/L)
Time frame: 24 hours
Alanine aminotransferase (ALAT) (UI/L)
Time frame: 24 hours
Alkaline Phosphatase PALK (UI/L)
Time frame: 24 hours
Bilirubin (μmol/L)
Time frame: 24hours
Gamma-Glutamyl transpeptidase (UI/L)
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sihem BENABOUD, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florentia KAGUELIDOU, MD, PhD (01 40 03 41 42 ext. +33, florentia.Kaguelidou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.