Effectiveness and tolerability of ibuprofen-arginine versus paracetamol in children with fever of likely infectious origin.
Acta Paediatr
; 91(4): 383-90, 2002.
Article
em En
| MEDLINE
| ID: mdl-12061352
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Arginina
/
Ibuprofeno
/
Analgésicos não Narcóticos
/
Febre
/
Acetaminofen
Tipo de estudo:
Clinical_trials
Limite:
Child
/
Child, preschool
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Acta Paediatr
Ano de publicação:
2002
Tipo de documento:
Article
País de afiliação:
Espanha