Elsevier

American Journal of Otolaryngology

Volume 35, Issue 6, November–December 2014, Pages 766-770
American Journal of Otolaryngology

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

https://doi.org/10.1016/j.amjoto.2014.06.006Get rights and content

Abstract

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.

Introduction

Otitis media with effusion (OME) or glue ear is collection of fluid behind the tympanic membrane without inflammatory signs present for six weeks [1]. By the age of 4 years, approximately 80% of children will have had an episode of otitis media with effusion, most of which resolve and only 10% of episodes last for a year or more [2].

The sterile fluid in the middle ear mechanically dampens the transmission of sound and results in the significant conductive hearing loss. This hearing loss especially when bilateral has an important impact on children’s lives and development [3].

The adenoids are pyramid-shaped aggregation of lymphoid tissue in the nasopharynx which are present at birth. Adenoids when enlarged obstruct the nasopharyngeal airway and cause nasal obstruction, mouth-breathing, rhinorrhoea, snoring and hyponasal voice. Adenoid when enlarged can mechanically obstruct the eustachian tube opening and is a known cause for OME.

Traditionally adenoidectomy with grommet insertion is considered to be the treatment of choice. Various conservative approach to it’s management are under research. Recently role of steroids in such context has been explored. Topical steroids nasal spray may be beneficial, are under-research and more robust evidence are needed [4], [5], [6], [7], [8], [9], [10].

Mometasone furoate when used as nasal spray has lower bioavailability, extensive first pass metabolism and a relatively higher binding affinity for the glucocorticoid receptor than the other intranasal corticosteroids [11]. Mometasone furoate nasal spray does not suppresses the function of the hypothalamic-pituitary adrenal axis when administered at clinically relevant doses of 100–200 mcg/day [11].

The present study was undertaken to evaluate the role of mometasone furoate nasal spray in children of persistent OME with adenoidal hypertrophy.

Section snippets

Materials and methods

This prospective randomized double blind interventional placebo control study enrolled 100 patients with the symptoms of adenoidal hypertrophy attending the Department of Otorhinolaryngology and Head & Neck Surgery, Lady Hardinge Medical College and associated Kalawati Saran Children’s Hospital, New Delhi from October 2011 to march 2013. The patients of age 2–12 years of both sexes having grade 3 and 4 adenoidal hypertrophy according to Cassano classification [12] with duration of symptoms for

Results

62 children (62%) between ages 2–12 years had bilateral OME on tympanometric analysis. The maximum incidence was seen in the age group 6–9 years (53%) with a mean age of 7.4 years (Table 1). PTA could be done in 48 patients (26 group A and 22 group B) and 20.4 dB of average hearing loss was seen before the initiation of therapy. The average loss post therapy in group A was 5.2 dB while in group B was 11.6 dB. This change in hearing with therapy between two groups was statistically significant (

Discussion

Otitis media with effusion in children is a global health problem due to its negative impact on quality of life. It is one of the most common causes of treatable conductive hearing loss. Many patients remain undiagnosed especially in developing countries which can lead to poor performance in school and affect the overall development of the child.

In recent year’s concept of medical treatment have developed. Many studies have been conduced however the usefulness of steroid spray in patients of

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