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

ABSTRACT

UNLABELLED 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 6.67 mg/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 (degrees C) showed no difference between groups (p = 0.527) but more patients in the ibuprofen-arginine group attained a temperature reduction greater than 2 degrees 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.