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The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo.
The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracetamol (acetaminophen) | Active Comparator | patient will receive1 gramme of paracetamol intravenously |
|
| Placebo | Placebo Comparator | patient will receive 100 ml of chlorure de sodium 0,9% intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | >50kg: Paracetamol 1 gramme in a solution of 10mg/mL administred intravenously. 1 dose >50kg: Paracetamol 15mg/kg/dose in a solution 10mg/mL administred intravenously. 1 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group) | measurement of intracerebral temperature in degrees | Six hours after administration of treatment |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Marine de Mesmay, MD | Fondation Ophtalmologique Adolphe de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation Adolphe de Rothschild | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41217349 | Derived | de Mesmay M, Geral L, Gregoire C, Roy M, Welschbillig S, Le Cossec C, Engrand N. Effect of Paracetamol on Cerebral Temperature in Febrile Brain-Injured Patients. The NEUROTHERM Study: A Randomized Controlled Pharmacodynamic Trial. Crit Care Med. 2026 Jan 1;54(1):108-118. doi: 10.1097/CCM.0000000000006951. Epub 2025 Nov 11. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo | Drug | 100mL of chlorure de sodium 0.9% administred intravenously. 1 dose |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Aniline Compounds |
| D000588 | Amines |