The effect of montelukast sodium on the duration of effusion of otitis media.

This study tests the hypothesis that montelukast sodium, a selective leukotriene receptor antagonist, will decrease the duration of the effusion of otitis media. Tympanometry and spectral gradient acoustic reflectometry were used to confirm the effusion of otitis media in patients between 2 and 12 years of age. Patients were treated with amoxicillin for 10 days and montelukast sodium or placebo for 30 days in a random, double-blind manner. Sixty patients completed the study: 31 received placebo and 29 received montelukast sodium. At a 4-week follow-up visit, 5 ears (16%) were free of effusion in the placebo group and 17 (58%) in the montelukast sodium group. The difference was significant. The efficacy of montelukast sodium in clearing the effusion was 49%.

RCT Entities:   Population Interventions Outcomes