Effect of Paracetamol on Cerebral Temperature in Febrile Brain-Injured Patients. The NEUROTHERM Study: A Randomized Controlled Pharmacodynamic Trial
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 99 participants or records.
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