OBJECTIVES: An intravenous formulation of paracetamol and an intravenous formulation of propacetamol (prodrug of paracetamol) were compared in children with acute fever due to infection in order to determine the antipyretic efficacy and safety during the 6-hour period after administration. METHODS: A total of 67 patients aged 1 month to 12 years and with a rectal body temperature between 38.5 degrees C and 41 degrees C, were randomized to receive either intravenous paracetamol 15 mg/kg (n = 35) or propacetamol 30 mg/kg (n = 32) under double-blind conditions. RESULTS: The non-inferiority of intravenous paracetamol compared to propacetamol was demonstrated (non-inferiority margin = 0.5 degrees C) by the median body temperature reduction of 1.9 degrees C in the intravenous paracetamol group and the reduction of 2.05 degrees C in the propacetamol group. The difference in the incidence of local adverse events was statistically significant (p = 0.0134) with more local adverse events in the propacetamol group (9, 28.1%) than in the intravenous paracetamol group (2, 5.7%). CONCLUSION: This double-blind, randomized, clinical trial demonstrates the non-inferiority of a single administration of 15 mg/kg intravenous paracetamol in comparison to 30 mg/kg propacetamol in terms of body temperature reduction in children aged 1 month to 12 years with acute fever due to infection. It confirms the better local safety of intravenous paracetamol in comparison to propacetamol.
RCT Entities:
OBJECTIVES: An intravenous formulation of paracetamol and an intravenous formulation of propacetamol (prodrug of paracetamol) were compared in children with acute fever due to infection in order to determine the antipyretic efficacy and safety during the 6-hour period after administration. METHODS: A total of 67 patients aged 1 month to 12 years and with a rectal body temperature between 38.5 degrees C and 41 degrees C, were randomized to receive either intravenous paracetamol 15 mg/kg (n = 35) or propacetamol 30 mg/kg (n = 32) under double-blind conditions. RESULTS: The non-inferiority of intravenous paracetamol compared to propacetamol was demonstrated (non-inferiority margin = 0.5 degrees C) by the median body temperature reduction of 1.9 degrees C in the intravenous paracetamol group and the reduction of 2.05 degrees C in the propacetamol group. The difference in the incidence of local adverse events was statistically significant (p = 0.0134) with more local adverse events in the propacetamol group (9, 28.1%) than in the intravenous paracetamol group (2, 5.7%). CONCLUSION: This double-blind, randomized, clinical trial demonstrates the non-inferiority of a single administration of 15 mg/kg intravenous paracetamol in comparison to 30 mg/kg propacetamol in terms of body temperature reduction in children aged 1 month to 12 years with acute fever due to infection. It confirms the better local safety of intravenous paracetamol in comparison to propacetamol.