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