The Effect of Paracetamol on Brain Temperature

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Treatments: Acetaminophen

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