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Effect of Paracetamol on Cerebral Temperature in Febrile Brain-Injured Patients. The NEUROTHERM Study: A Randomized Controlled Pharmacodynamic Trial.

Marine de Mesmay,Laurane Geral,Charles Grégoire,Mickaela Roy,S. Welschbillig,Chloé Le Cossec,Nicolas Engrand

Published 2025 in Critical Care Medicine

ABSTRACT

OBJECTIVE Hyperthermia is common in brain-injured patients and is considered a systemic secondary brain injury. Paracetamol is most often administered as first-line treatment, although its efficacy in controlling cerebral temperature (CT) has never been evaluated, which is the aim of this study. DESIGN Pharmacodynamic prospective randomized double-blind placebo-controlled study. SETTING Neuro-ICU. PATIENTS Brain-injured patients who were febrile (CT ≥ 38.5°C for > 30 min) and monitored with an intracerebral pressure sensor including a thermal probe. INTERVENTIONS Patients received paracetamol or placebo (only one IV administration). CT and systemic temperature (ST) were recorded every 10 minutes over 6 hours. MEASUREMENTS AND MAIN RESULTS The primary endpoint was the difference in mean CT over 6 hours after treatment. The primary endpoint was the difference in mean CT over6 hours after treatment. We included 99 patients (mean age 55 ± 13 yr, 24% female): 49 in the paracetamol group and 50 in the placebo group. Mean CT during the 6-hour follow-up was significantly lower in the paracetamol than placebo group: 38.4 ± 0.5 vs. 39.0 ± 0.5°C (p < 0.001). In both groups, mean CT was always higher than mean ST: 38.7 ± 0.6 vs. 38.4 ± 0.6°C (p < 0.001). Median time with CT less than 38.5°C was 215 minutes (interquartile range 0-290) in the paracetamol group vs. 0 minutes (0-5) in the placebo group (p < 0.001). One-third (30%) of patients in the paracetamol group did not respond to treatment. In the responder group paracetamol lowered the mean CT by 1°C. The paracetamol group exhibited a moderate decrease in systolic arterial pressure and heart rate, without any other significant effect. CONCLUSIONS Paracetamol significantly reduced CT in febrile brain-injured patients (overall mean reduction of 0.6°C), maintaining temperatures less than 38.5°C for a median of 3.6 hours. The gradient between CT and ST was consistently about 0.3°C in both groups.

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