We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Effectiveness and tolerability of ibuprofen-arginine versus paracetamol in children with fever of likely infectious origin.
- Authors
Figueras Nadal, C; García De Miguel, Mª J; Gómez Campderá, A; Pou Fernández, J; Alvarez Calatayud, G; Sánchez Bayle, M; García de Miguel, Ma J; Gómez Campderá, A; Pou Fernández, J; Sánchez Bayle, M; Paediatric Fever Co-operative Group from the Spanish Paediatric Association
- Abstract
<bold>Unlabelled: </bold>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.<bold>Conclusion: </bold>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.
- Subjects
IBUPROFEN; ANTIPYRETICS; ACETAMINOPHEN; FEVER in children; DRUG efficacy; ARGININE; BIOLOGICAL assay; COMBINATION drug therapy; CLINICAL trials; COMPARATIVE studies; FEVER; RESEARCH methodology; MEDICAL cooperation; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; NONOPIOID analgesics; THERAPEUTICS
- Publication
Acta Paediatrica, 2002, Vol 91, Issue 4, p383
- ISSN
0803-5253
- Publication type
journal article
- DOI
10.1111/j.1651-2227.2002.tb01659.x