Conditions: Acute Otitis Media Otitis Media Ear Infection
Keywords: Ear Infections Otitis Media
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Detailed description:
Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Arms:
arm 1: Treatment with montelukast for 4 months (4 mg per day) arm 2: Treatment with placebo for 4 months

Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: