BackgroundOtitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue.ObjectiveTo compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.MethodsThis randomized controlled trial was done on 2- to 6-year-old children attending Koodakan Hospital in Bandar Abbas, southern Iran, in 2014. Patients were divided into three groups of montelukast, mometasone, and control group. Audiometry was done for all patients at baseline and four weeks after treatment. Patients were compared for treatment results. Data were analyzed using SPSS 21.0 software.ResultsA total of 143 children were included in the study. Mean age of the participants were 44.64 ± 18.03 months. There was no significant difference in treatment results in different treatment groups (p>0.05).ConclusionMometasone and montelukast are not effective and not recommended in treatment of otitis media with effusion in children. More studies are needed in this regard.Trial registrationThis study is registered at ClinicalTrials.gov with ClinicalTrials.gov Identifier: NCT02541760.FundingThe authors received financial support for this research from Hormozgan University of Medical Sciences.