Based on the present results, ibuprofen-arginine oral drops have shown to be a safe, well-tolerated and potent paediatric antipyretic agent. Hence, ibuprofen-arginine should be considered as an adequate choice for the control of paediatric fever of likely infectious aetiology.

The aim of this multicentre, double‐blind, randomized study was to assess the paediatric antipyretic efficacy of a new ibuprofen formulation containing L‐arginine for gastric protection, compared with the efficacy of paracetamol. For this purpose 100 patients were given ibuprofen‐arginine (1 drop/kg: 6.67mg/kg) and 99 paracetamol (4 drops/kg: 10.65 mg/kg). The main efficacy endpoint was the mean change in tympanic temperature 4 h after drug intake. Twelve patients were excluded because of early vomiting or spitting out the medication. The resulting efficacy analysis population included a total of 88 patients treated with ibuprofen‐arginine and 87 with paracetamol. Mean change in tympanic temperature (°C) showed no difference between groups (p= 0.527) but more patients in the ibuprofen‐arginine group attained a temperature reduction greater than 2°C (p= 0.043). A total of 107 patients required antipyretic rescue medication, with a smaller proportion in the ibuprofen‐arginine group. Although this was not statistically significant, a trend towards improved activity was observed (p= 0.100). Overall efficacy was judged from the recovery or improvement in 68.8% of patients in the ibuprofen‐arginine group compared with 65.5% in the paracetamol group. Nineteen patients reported adverse events, with vomiting being the most common complaint, but no differences were detected between treatments. Conclusion: Based on the present results, ibuprofen‐arginine oral drops have shown to be a safe, well‐tolerated and potent paediatric antipyretic agent. Hence, ibuprofen‐arginine should be considered as an adequate choice for the control of paediatric fever of likely infectious aetiology.