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The Effect of Paracetamol on Brain Temperature

NCT03648021 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-27

No results posted yet for this study

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

Interventions

DRUG

Paracetamol

\>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

DRUG

Placebo

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

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Marine de Mesmay, MD · Fondation Ophtalmologique Adolphe de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2022-05-26
Completion
2022-05-26

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648021 on ClinicalTrials.gov