Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry

Primary end point for efficacy was the reduction in the tympanic temperature from the baseline temperature at the end of 4 h after drug administration. 

Secondary end points were – Percent reduction of temperature from baseline to 4 h post dose, proportion of afebrile children at 1, 2, 3 and 4 h post dose, any adverse drug events occurring during the 4 h period as recorded by the investigators and causality assessed with the help of Naranjo’s algorithm

Significant difference between three groups (P = 0.013), maximum reduction in temperature being observed in paracetamol-ibuprofen combination and minimum in paracetamol group

Highest fall of temperature was noted in the 1st h of drug administration in all the groups

Difference between combination and paracetamol was significant for the 1st h (P = 0.04) 

Number of afebrile children any time post dose until 4 h was highest in the combination group

No serious or severe adverse events were noted in any of the groups.

Temperature reduction with paracetamol and ibuprofen combination was quicker temperature reduction than either paracetamol or ibuprofen alone. 

Combination of paracetamol-ibuprofen may have marginal clinical benefit over ibuprofen or paracetamol alone in routine clinical practice only when quicker reduction in body temperature is the goal of therapy.