Safety of Paracetamol and Ibuprofen in Febrile Children

Summary

The increasing use of ibuprofen for the treatment of fever in children has caused concern about possible toxic effects. In susceptible adults ibuprofen has caused kidney dysfunction. While it is unlikely that a child with known kidney disease would be given ibuprofen, many children with febrile illnesses are dehydrated. This report presents an analysis of pre- and poststudy observations from 2 clinical trials that compared the antipyretic effects of ibuprofen and paracetamol in 180 otherwise healthy febrile children.

In the first trial, 119 febrile children received a single oral dose of either placebo, paracetamol or one of 2 doses of ibuprofen. In the second trial, 61 children received either paracetamol or one of 3 doses of ibuprofen orally every 6 hours for between 24 and 48 hours. Pre- and poststudy blood chemistries, urine and vital signs were analysed.

Liberal statistical analyses identified few adverse effects and no clinically significant adverse effects. Statistically significant changes were all consistent with poststudy haemodilution (rehydration) except for blood urea nitrogen (BUN). Poststudy BUN concentrations were statistically significantly greater than prestudy values for paracetamol- and ibuprofen-treated patients. However, none of the BUN results were abnormal or clinically important.

Although this study found no clinically significant adverse effects, much larger studies are necessary to establish safety in the general population.