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Una evaluación de la seguridad del ibuprofeno pediátrico. Un ensayo clínico aleatorizado basado en el practicante
1Slone Epidemiology Unit, School of Public Health, Boston University School of Medicine, Brookline, MA 02146.
JAMA
|March 22, 1995
Resumen
El uso a corto plazo de ibuprofeno en niños no aumentó las hospitalizaciones por sangrado gastrointestinal, insuficiencia renal o anafilaxia. Este estudio se centró en resultados graves específicos, no en eventos menos graves o uso prolongado.
Área de la Ciencia:
- Farmacología pediátrica farmacología pediátrica.
- La investigación clínica es la investigación clínica.
- La seguridad de las drogas.
Sus antecedentes:
- La fiebre es común en los niños, a menudo tratada con antipiréticos como el ibuprofeno y el acetaminofén.
- Existen preocupaciones con respecto a los posibles eventos adversos graves asociados con el ibuprofeno en poblaciones pediátricas.
- Comprender los perfiles comparativos de seguridad de los antipiréticos comunes es crucial para la práctica clínica.
Objetivo del estudio:
- Evaluar si el ibuprofeno aumenta el riesgo de hospitalización por eventos adversos graves específicos en niños con fiebre.
- Para comparar la seguridad del ibuprofeno frente al acetaminofén en una gran cohorte pediátrica.
- Para investigar las hospitalizaciones por sangrado gastrointestinal, insuficiencia renal y anafilaxia.
Principales métodos:
- Se realizó un ensayo aleatorizado, doble ciego, controlado con acetaminofén en pacientes ambulatorios pediátricos y de medicina familiar.
- 84,192 niños con fiebre fueron asignados al azar para recibir acetaminofén o una de las dos dosis de ibuprofeno.
- Los resultados primarios incluyeron hospitalizaciones por sangrado gastrointestinal agudo, insuficiencia renal aguda y anafilaxia.
Principales resultados:
- Las tasas de hospitalización no diferían entre los grupos de ibuprofeno y acetaminofén.
- Se produjeron cuatro casos de hemorragia gastrointestinal no grave, sin diferencia significativa en el riesgo entre el ibuprofeno y el acetaminofén.
- No se observaron hospitalizaciones por insuficiencia renal aguda o anafilaxia; las estimaciones de riesgo fueron bajas para los niños tratados con ibuprofeno.
Conclusiones:
- El uso a corto plazo de ibuprofeno en niños no se asocia con un mayor riesgo de hospitalización por hemorragia gastrointestinal, insuficiencia renal o anafilaxia.
- El estudio proporciona evidencia de la seguridad del ibuprofeno con respecto a estos resultados graves específicos.
- Los datos no se extienden a resultados menos graves o riesgos asociados con el uso prolongado de ibuprofeno.
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