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Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection

AIM: No randomized study has been conducted to investigate the use of intravenous paracetamol (acetaminophen, APAP) for the management of fever due to infection. The present study evaluated a new ready‐made infusion of paracetamol. METHODS: Eighty patients with a body temperature onset ≥38.5°C in th...

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Autores principales: Tsaganos, Thomas, Tseti, Ioulia K., Tziolos, Nikolaos, Soumelas, Georgios‐Stefanos, Koupetori, Marina, Pyrpasopoulou, Athina, Akinosoglou, Karolina, Gogos, Charalambos, Tsokos, Nikolaos, Karagiannis, Asterios, Sympardi, Styliani, Giamarellos‐Bourboulis, Evangelos J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346867/
https://www.ncbi.nlm.nih.gov/pubmed/27792836
http://dx.doi.org/10.1111/bcp.13173
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author Tsaganos, Thomas
Tseti, Ioulia K.
Tziolos, Nikolaos
Soumelas, Georgios‐Stefanos
Koupetori, Marina
Pyrpasopoulou, Athina
Akinosoglou, Karolina
Gogos, Charalambos
Tsokos, Nikolaos
Karagiannis, Asterios
Sympardi, Styliani
Giamarellos‐Bourboulis, Evangelos J.
author_facet Tsaganos, Thomas
Tseti, Ioulia K.
Tziolos, Nikolaos
Soumelas, Georgios‐Stefanos
Koupetori, Marina
Pyrpasopoulou, Athina
Akinosoglou, Karolina
Gogos, Charalambos
Tsokos, Nikolaos
Karagiannis, Asterios
Sympardi, Styliani
Giamarellos‐Bourboulis, Evangelos J.
author_sort Tsaganos, Thomas
collection PubMed
description AIM: No randomized study has been conducted to investigate the use of intravenous paracetamol (acetaminophen, APAP) for the management of fever due to infection. The present study evaluated a new ready‐made infusion of paracetamol. METHODS: Eighty patients with a body temperature onset ≥38.5°C in the previous 24 h due to infection were randomized to a single administration of placebo (n = 39) or 1 g paracetamol (n = 41), and their temperature was recorded at standard intervals. Rescue medication with 1 g paracetamol was allowed. Serum samples were collected for the measurement of APAP and its metabolites. The primary endpoint was defervescence, defined as a core temperature ≤37.1°C. RESULTS: During the first 6 h, defervescence was achieved in 15 (38.5%) patients treated with placebo compared with 33 (80.5%) patients treated with paracetamol 1 g (P < 0.0001). The median time to defervescence with paracetamol 1 g was 3 h. Rescue medication was given to 15 (38.5%) and five (12.2%) patients allocated to placebo and paracetamol, respectively (P = 0.007); nine (60.0%) and two (40.0%) of these patients, respectively, experienced defervescence. No further antipyretic medication was needed for patients becoming afebrile with rescue medication. Serum glucuronide‐APAP concentrations were significantly greater in the serum of patients who did not experience defervescence with paracetamol. The efficacy of paracetamol was not affected by serum creatinine. No drug‐related adverse events were reported. CONCLUSIONS: The 1 g paracetamol formulation has a rapid and sustainable antipyretic effect on fever due to infection. Its efficacy is dependent on hepatic metabolism.
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spelling pubmed-53468672017-03-14 Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection Tsaganos, Thomas Tseti, Ioulia K. Tziolos, Nikolaos Soumelas, Georgios‐Stefanos Koupetori, Marina Pyrpasopoulou, Athina Akinosoglou, Karolina Gogos, Charalambos Tsokos, Nikolaos Karagiannis, Asterios Sympardi, Styliani Giamarellos‐Bourboulis, Evangelos J. Br J Clin Pharmacol Clinical Trials AIM: No randomized study has been conducted to investigate the use of intravenous paracetamol (acetaminophen, APAP) for the management of fever due to infection. The present study evaluated a new ready‐made infusion of paracetamol. METHODS: Eighty patients with a body temperature onset ≥38.5°C in the previous 24 h due to infection were randomized to a single administration of placebo (n = 39) or 1 g paracetamol (n = 41), and their temperature was recorded at standard intervals. Rescue medication with 1 g paracetamol was allowed. Serum samples were collected for the measurement of APAP and its metabolites. The primary endpoint was defervescence, defined as a core temperature ≤37.1°C. RESULTS: During the first 6 h, defervescence was achieved in 15 (38.5%) patients treated with placebo compared with 33 (80.5%) patients treated with paracetamol 1 g (P < 0.0001). The median time to defervescence with paracetamol 1 g was 3 h. Rescue medication was given to 15 (38.5%) and five (12.2%) patients allocated to placebo and paracetamol, respectively (P = 0.007); nine (60.0%) and two (40.0%) of these patients, respectively, experienced defervescence. No further antipyretic medication was needed for patients becoming afebrile with rescue medication. Serum glucuronide‐APAP concentrations were significantly greater in the serum of patients who did not experience defervescence with paracetamol. The efficacy of paracetamol was not affected by serum creatinine. No drug‐related adverse events were reported. CONCLUSIONS: The 1 g paracetamol formulation has a rapid and sustainable antipyretic effect on fever due to infection. Its efficacy is dependent on hepatic metabolism. John Wiley and Sons Inc. 2016-12-07 2017-04 /pmc/articles/PMC5346867/ /pubmed/27792836 http://dx.doi.org/10.1111/bcp.13173 Text en © 2016 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Clinical Trials
Tsaganos, Thomas
Tseti, Ioulia K.
Tziolos, Nikolaos
Soumelas, Georgios‐Stefanos
Koupetori, Marina
Pyrpasopoulou, Athina
Akinosoglou, Karolina
Gogos, Charalambos
Tsokos, Nikolaos
Karagiannis, Asterios
Sympardi, Styliani
Giamarellos‐Bourboulis, Evangelos J.
Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
title Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
title_full Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
title_fullStr Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
title_full_unstemmed Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
title_short Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
title_sort randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
topic Clinical Trials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346867/
https://www.ncbi.nlm.nih.gov/pubmed/27792836
http://dx.doi.org/10.1111/bcp.13173
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