Evaluación de la eficacia antipirética y seguridad de dos formulaciones pediátricas de ibuprofeno
- J. Díez Domingo
- M. Victoria Planelles Cantarino
- Francisco Moreno
- J. Uberos Fernández
- J. Moreno Martín
- A. Molina Carballo
- J. Antelo Cortizas
- Santos Armenteros González
- R Domínguez Granados
- E. Moreno Carretero
Year of publication: 2000
Volume: 53
Issue: 5
Pages: 436-440
Type: Article
Sustainable development goals
Abstract
Objectives To compare the efficacy and to evaluate the clinical bioequivalence of two different formulations of ibuprofen (suspension and effervescent granules) in febrile children. Methods An open, randomized, multicenter study. Febrile children (axillary temperature 38 °C) weighing more than 25 kg, admitted into the emergency departments of the participating hospitals were randomly assigned to either of the two treatment groups: ibuprofen suspension (7 mg/kg) or effervescent granules at the following dosages: 200 mg in children weighing 25-40 kg or 400 mg in children weighing 35-40 kg and with an axillary temperature above 39 °C. This latter dose of 400 mg was also given to children weighing more than 40 kg. The investigators took axillary temperature before treatment and 30, 60, 90, 120, 180 and 240 min after administration of the corresponding dose. Possible adverse events were noted. Results A total of 103 patients were included in the study; 51 received the effervescent granules and 52 received the suspension formulation. The mean temperature was reduced in both groups during the study (p, 0.005). No differences were found between the formulations. The mean differences of temperatures at each point of the study were within the clinical bioequivalence interval (6 0.5 °C). Only one patient had an axillary temperature of 35.9 °C. This was the only adverse event recorded in the study. Conclusions Both ibuprofen formulations were effective in reducing fever and may be considered clinically bioequivalent.