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Randomized Controlled Trial Multicenter Study
The Effect of Paracetamol on Core Body Temperature in Acute Traumatic Brain Injury: A Randomised, Controlled Clinical Trial.
- Manoj K Saxena, Colman Taylor, Laurent Billot, Severine Bompoint, John Gowardman, Jason A Roberts, Jeffery Lipman, and John Myburgh.
- Division of Critical Care and Trauma Division, The George Institute for Global Health, Sydney, New South Wales, Australia.
- Plos One. 2015 Jan 1; 10 (12): e0144740.
BackgroundStrategies to prevent pyrexia in patients with acute neurological injury may reduce secondary neuronal damage. The aim of this study was to determine the safety and efficacy of the routine administration of 6 grams/day of intravenous paracetamol in reducing body temperature following severe traumatic brain injury, compared to placebo.MethodsA multicentre, randomised, blind, placebo-controlled clinical trial in adult patients with traumatic brain injury (TBI). Patients were randomised to receive an intravenous infusion of either 1g of paracetamol or 0.9% sodium chloride (saline) every 4 hours for 72 hours. The primary outcome was the mean difference in core temperature during the study intervention period.ResultsForty-one patients were included in this study: 21 were allocated to paracetamol and 20 to saline. The median (interquartile range) number of doses of study drug was 18 (17-18) in the paracetamol group and 18 (16-18) in the saline group (P = 0.85). From randomisation until 4 hours after the last dose of study treatment, there were 2798 temperature measurements (median 73 [67-76] per patient). The mean ± standard deviation temperature was 37.4±0.5°C in the paracetamol group and 37.7±0.4°C in the saline group (absolute difference -0.3°C; 95% confidence interval -0.6 to 0.0; P = 0.09). There were no significant differences in the use of physical cooling, or episodes of hypotension or hepatic abnormalities, between the two groups.ConclusionThe routine administration of 6g/day of intravenous paracetamol did not significantly reduce core body temperature in patients with TBI.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12609000444280.
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