Title
A New Formulation of Intravenous Paracetamol for Fever Management
A Double-blind, Randomized, Placebo-controlled Phase IV Clinical Study of the Efficacy and Safety of a New Formulation of Paracetamol for the Management of Fever of Infectious Origin
Phase
Phase 4Lead Sponsor
Unipharm, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
FeverIntervention/Treatment
acetaminophen ...Study Participants
80The efficacy of intravenous paracetamol has never been compared with other drugs for the management of fever due to infections. Available data come from clinical studies conducted in healthy volunteers subject to experimental endotoxemia. The present study compares the efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin.
A new formulation of paracetamol for intravenous administration has been manufactured in Greece by the industry Uni-Pharma (ΑPOTEL Μax®). According to this new formulation, 1g of paracetamol is provided as a flask diluted into 100ml volume with the possibility of immediate connection with the infusion device of the patient. This formulation provides the advantage of a dilution ready-to-use which equals considerable financial benefit; nursing staff is not pre-occupied with the preparation of dilutions and the amount of consumables required for the preparation of this dilution is significantly decreased. Taking into consideration that the antipyretic effect of intravenous paracetamol has never been studied compared with other agents in patients and available data come from studies in volunteers with experimental endotoxemia, the present study compares the efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin (fever due to infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or of the skin and soft tissues).
The study drug is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein.
Placebo is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein. Placebo contains water for injection and inactive vehicles.
Active drug; water for injection at a volume of 100ml with added 1g of paracetamol and inactive ingredients (ΑPOTEL max®), infused within 15 minutes. Available in 100ml bags.
Placebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.
Inclusion Criteria: Written informed consent by the patient Patient of either gender Age equal to or greater than 18 years old Fever onset less than 24 hours Body temperature greater than or equal to 38.50C. Infection of the upper respiratory tract or of the lower respiratory tract or acute pyelonephritis or infection of the skin and soft tissues that can explain fever onset. Exclusion Criteria: Age below 18 years old Denial for written consent Intake of paracetamol for any reason either orally or intravenously or intramuscularly the last 12 hours Intake of any non-steroidal anti-inflammatory drug the last 8 hours Intake of any steroidal anti-inflammatory drug the last 12 hours History of liver cirrhosis Serum creatinine greater than 3 mg/dl Aspartate aminotransferase more than 3 times greater than the upper normal limit for the hospital lab Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol Pregnancy or lactation Active bleeding of the upper or the lower gastrointestinal tract Thrombocytopenia defined as any absolute platelet count below 50000/mm3.
