The Effect of Paracetamol on Brain Temperature

NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03648021

Acronym

NEUROTHERM

Enrollment

100

Registered

2018-08-27

Start date

2018-05-03

Completion date

2022-05-26

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

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.

Interventions

DRUGParacetamol

\>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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)	Six hours after administration of treatment	measurement of intracerebral temperature in degrees

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026