The Effect of Paracetamol on Brain Temperature

NCT03648021 | Completed Phase 4

• 1 other identifier: MDY_2017_19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

paracetamol (acetaminophen)

ACTIVE COMPARATOR

patient will receive1 gramme of paracetamol intravenously

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

patient will receive 100 ml of chlorure de sodium 0,9% intravenously

Drug: Placebo

Interventions

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

Also known as: acetaminophen

paracetamol (acetaminophen)

Placebo DRUG

100mL of chlorure de sodium 0.9% administred intravenously. 1 dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year or older patients
• Patient hospitalized in neuro-critical care for:
• Arachnoid hemorrhage
• Intra parenchymatous hematoma
• stroke
• Acute brain Severe injury
• Post-operative complication of an act of neurosurgery or programmed neuroradiology
• Sedation and mechanical ventilation planned \> 2 days
• Monitoring of intracranial temperature and pressure by intraparenchymal sensor (Sophysa®)
• Brain temperature \> 38.5°C for more than 30 minutes

You may not qualify if:

• Known hypersensitivity to paracetamol or mannitol (excipient with known effect)
• Severe hepatocellular insufficiency (ASAT or ALAT \> 5N, or bilirubin \> 2N)
• Pharmacological intervention (administration of corticosteroids, NSAIDs or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours.
• Pregnant or breastfeeding women
• Previous participation in this study

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 41217349 DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marine de Mesmay, MD

  Fondation Ophtalmologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 27, 2018
• Study Start: May 3, 2018
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

FR (1)