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


CONCLUSIONS
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.
Figueras Nadal
C
C
Infectious Disease Section, Hospital Universitari Materno-Infantil De La Vall D'Hebron, Barcelona, Spain. 9735mfn@webcmb.comb.es
García de Miguel
Ma J
MJ
Gómez Campderá
A
A
Pou Fernández
J
J
Alvarez Calatayud
G
G
Sánchez Bayle
M
M
D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001120:Arginine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004338:Drug Combinations; D023381:Endpoint Determination; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male
D018712:Analgesics, Non-Narcotic; D004338:Drug Combinations; D000082:Acetaminophen; D001120:Arginine; D007052:Ibuprofen; C106674:ibuprofen arginine