Effectiveness and tolerability of ibuprofen‐arginine versus paracetamol in children with fever of likely infectious origin

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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.