Clinical trial on the effect of buphenine, aminophenazone and diphenylpyraline hydrochloride in treating the common cold in children of 6 to 24 months of age

Autores: Montijo Barrios Ericka, Cadena Francisco, Ramírez Mayans Jaime Alfonso, Gutiérrez Castrellón Pedro

Resumen

Introduction: Acute respiratory infections ARIs) are the second most common cause of death in children less than 18 years old. Common cold is one of the most common ARIs in children. A number of drugs have been used with the goal to reduce the associated symptoms in common cold and improve quality of life. Objective: To evaluate the efficacy and safety of buphenine, aminophenazone and diphenylpyraline hydrochloride (Flumil®) compared to a placebo in order to control the symptoms associated with the common cold in children ages 6 to 24 months. Material and methods: A randomized, double-blind, placebo-controlled, clinical trial testing 100 children under the age of 24 months (both genders) with common colds, who received 7 days of medicine under the study conditions at a dose of 1 drop/kg/t.i.d. vs. the placebo. Both groups received parallel weight-appropriate doses of acetaminophen. The impact of the manipulations on associated respiratory symptomatology was compared using PASW 18.0 and STAT 11.0 for Mac. Results: Fifty-three children were randomly placed in the Flumil® group and 47 were placed in the placebo group. The average age of the placebo group was 12.2 ± 5.8 months (6 to 24 months) and the Flumil® group was 12.7 ± 5.8 months (6 to 23 months). Upon analysis of the symptoms during the days after initiating the study, we observed significant differences favoring the group that received Flumil®, which were most noticeable after the third day of treatment and were maintained throughout the study. Conclusions: The evidence indicated that Flumil® is a safe and effective drug for the control of symptoms associated with the common cold in children 6 to 24 months old.

Palabras clave: Flumil® common cold children.

2014-11-07   |   712 visitas   |   Evalua este artículo 0 valoraciones

Vol. 63 Núm.4. Julio-Agosto 2011 Pags. 335-343 Rev Invest Clin 2011; 63(4-ENGLISH)