Τίτλος:
Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2016 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.
Συγγραφείς:
Tsaganos, T.
Tseti, I.K.
Tziolos, N.
Soumelas, G.-S.
Koupetori, M.
Pyrpasopoulou, A.
Akinosoglou, K.
Gogos, C.
Tsokos, N.
Karagiannis, A.
Sympardi, S.
Giamarellos-Bourboulis, E.J.
Περιοδικό:
British Journal of Clinical Pharmacology
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
creatinine; drug metabolite; paracetamol; antipyretic agent; paracetamol, acute pyelonephritis; adult; Article; bacterial infection; body temperature; body temperature measurement; body temperature monitoring; controlled study; core temperature; creatinine blood level; defervescence; double blind procedure; drug blood level; drug efficacy; drug fatality; drug safety; female; fever; follow up; hospital admission; hospital patient; human; hypoglycemia; lower respiratory tract infection; major clinical study; male; middle aged; multicenter study; nausea; priority journal; randomized controlled trial; single drug dose; skin infection; upper respiratory tract infection; aged; clinical trial; complication; fever; hospitalization; infection; intravenous drug administration; time factor; treatment outcome, Acetaminophen; Administration, Intravenous; Adult; Aged; Antipyretics; Double-Blind Method; Female; Fever; Follow-Up Studies; Hospitalization; Humans; Infection; Male; Middle Aged; Time Factors; Treatment Outcome
