A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion

PurposeTo study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2–12 years with adenoidal hypertrophy and its impact on change in quality of life.MethodA prospective randomized double blind interventional placebo control study was conducted. Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2–12 years were enrolled in this study. Among these sixty two patients had persistent bilateral otitis media with effusion more than three months. These were randomly divided into two groups, group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period. Patients were evaluated with symptom, pure tone audiometry wherever possible, pneumatic otoscopic examination and tympanogram at 0, 8 and 24 weeks.ResultsResolution of otitis media with effusion in study group (28 out of 30) was significantly higher as compared control group (16 out of 32) (p value 0.0004). A significant improvement in hearing and symptoms was seen in the study group (p < 0.04). Statistically significant change in quality of life was seen with mometasone nasal spray (37.11) as compared to saline nasal spray (11.02) (p value 0.0001).ConclusionMometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy.