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

Purpose: To 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. Method: A 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. Results: Resolution 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). Conclusion: Mometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy. 2014 Elsevier Inc. All rights reserved.