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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01743-40 | Registry Identifier | ID-RCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blood sampling scheme1 | 3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1 |
| |
| blood sampling scheme2 | 3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titration of paracetamol and its metabolites - scheme1 | Biological | 15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Aspartate aminotransferase (ASAT) (UI/L) | Liver function tests | 24 hours |
| Alanine aminotransferase (ALAT) (UI/L) | Liver function tests |
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Inclusion Criteria:
Exclusion Criteria:
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Non-obese, overweight and obese children aged 6 to 17 scheduled for surgery requiring intravenous (IV) paracetamol injection intraoperatively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florentia KAGUELIDOU, MD, PhD | Contact | 01 40 03 41 42 | +33 | florentia.Kaguelidou@aphp.fr |
| Karima MESBAHI-IHADJADENE, Project manager | Contact | 01 58 41 12 11 | +33 | karima.mesbahi@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sihem BENABOUD, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debré University Hospital | Paris | 75019 | France |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Titration of paracetamol and its metabolites - scheme 2 | Biological | 30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration) |
|
| 24 hours |
| Alkaline Phosphatase PALK (UI/L) | Liver function tests | 24 hours |
| Bilirubin (μmol/L) | Liver function tests | 24hours |
| Gamma-Glutamyl transpeptidase (UI/L) | Liver function tests | 24 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |