The hypotension caused by intravenous paracetamol in septic shock patients: A single center placebo controlled randomized study

Abstract

: According to the product information for parenteral paracetamol, fewer than 1% of patients will have more severe adverse effects like hypotension. However, a number of studies suggest that the prevalence of hypotension caused by parenteral paracetamol may be higher than actually thought by the drug's producers. We carried out prospective, controlled, randomized research to compare the clinical implications of intravenous paracetamol bolus versus intravenous paracetamol extended infusion. The 61 adult septic shock patients were divided into three groups by randomization: Bolus group who received paracetamol 1g/100ml infused over 15 minutes, while the extended infusion group who received paracetamol 1g/100ml infused over three hours. The control group who received normal saline 100ml infused over 15 minutes. The main outcome was the incidence and prevalence of reduced blood pressure, which was detected by a systolic blood pressure drop of ≥ 20 ٪ from baseline. Mean arterial pressure, vasopressor infusion flow rate, and both diastolic and systolic blood pressure did not change significantly according to statistical analysis between the three groups at baseline, one, three, or six hours after the intervention. The incidence of hypotension was 19% (4 of 21 patients) within the control or normal saline group, 50% (10 of 20 patients) within the bolus group, and 35% (7 of 20) within the extended infusion group. The prevalence of hypotensive episodes was greater in the bolus group, even though there was no clinically meaningful difference between intravenous paracetamol prolonged infusion and bolus. We do not need to administer paracetamol as a prolonged infusion to prevent the hemodynamics parameter from being negatively impacted.