TY - JOUR
TI - Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
AU - Tsaganos, T.
AU - Tseti, I.K.
AU - Tziolos, N.
AU - Soumelas, G.-S.
AU - Koupetori, M.
AU - Pyrpasopoulou, A.
AU - Akinosoglou, K.
AU - Gogos, C.
AU - Tsokos, N.
AU - Karagiannis, A.
AU - Sympardi, S.
AU - Giamarellos-Bourboulis, E.J.
JO - British Journal of Clinical Pharmacology
PY - 2017
VL - 83
TODO - 4
SP - 742-750
PB - Wiley-Blackwell Publishing Ltd
SN - 0306-5251, 1365-2125
TODO - 10.1111/bcp.13173
TODO - 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
TODO - 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.
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