The Effect of Paracetamol on Brain Temperature

Phase 4

Completed

• Conditions: Brain Injuries
• Interventions: Drug: Placebo; Drug: Paracetamol

• Registration Number: NCT03648021
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-03
• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patient will receive 100 ml of chlorure de sodium 0,9% intravenously
paracetamol (acetaminophen)	Paracetamol	patient will receive1 gramme of paracetamol intravenously

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France