The Effect of Paracetamol on Brain Temperature (NEUROTHERM)

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase

Completed

Phase 4

Conditions

Brain Injuries

Treatments

Drug: Placebo

Drug: Paracetamol

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT03648021

MDY_2017_19

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

18-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

Exclusion Criteria

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