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.
1
Introduction
Otitis media with effusion (OME) or glue ear is collection of fluid behind the tympanic membrane without inflammatory signs present for six weeks . 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 .
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 .
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 .
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 . 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 .
The present study was undertaken to evaluate the role of mometasone furoate nasal spray in children of persistent OME with adenoidal hypertrophy.
2
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 with duration of symptoms for at least 3 months and not responsive to previous medical treatment were enrolled. The exclusion criteria were: 1) previous adenoidectomy, 2) use of intranasal topical or systemic steroid in last 1 year, 3) associated marked tonsillar hypertrophy, 4) anatomic deformity of the nose or sinonasal disease such as nasal polyposis or inferior turbinate hypertrophy, 5) craniofacial abnormalities such as cleft lip/cleft palate, 6) genetic diseases such as Down Syndrome, 7) acute upper respiratory infection within 2 weeks of enrolling in the study, and 8) patients with any clinically significant metabolic cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease.
Detailed history and ENT examination including pneumatic otoscopy were done at Vo. Clinical grading of symptom score was done ranging from 0 to 3 (0 = absent; 1 = occasional; 2 = frequent; 3 = daytime and night-time symptoms) to assess the degree of nasal obstruction, rhinorrhoea, cough, snoring and obstructive sleep apnoea at baseline (V0), 8(V1) and 24(V2) weeks visits. These patients were subjected to tympanometry, pure tone audiometry (PTA) wherever possible and nasopharyngoscopy under local anaesthetic spray (lignocaine spray 15%)/sedation with midazolam if required using rigid 2.7 mm/4 mm diameter nasal telescope. The endoscopy was videotaped and stored by AIDA (Advanced Interface Database Application) and still photographs were taken from the video ( Fig. 1 ). The grading of adenoidal hypertrophy was noted as described by Cassano et al. .
62 patients of adenoidal hypertrophy were diagnosed with bilateral otitis media with effusion on otoscopy & tympanometry (modified Jeger’s type B or C2) and were included . The study was approved by institutional ethical committee. Written informed consent was taken from the parents/caregiver before enrollment.
The children included in this study were divided into 2 groups randomly by chit selection into group A (study) and the group B (control). The group A received initial treatment of 2 puffs of mometasone furoate nasal spray (50 mcg/puff) in each nostril once a day, a total of 200 mcg/day for the first 8 weeks. This was followed by a maintenance dose of 2 puffs of mometasone furoate nasal spray in each nostril on alternate days for 16 weeks. The group B received initial treatment of 2 puffs of saline nasal spray in each nostril once a day for 8 weeks, followed by 2 puffs of saline nasal spray on alternate days for 16 weeks.
Follow-up was done at every 2 weeks for the first 8 weeks and then monthly for the next 16 weeks. Patients bottle were checked on the each visit for compliance to therapy and any local adverse effect were recorded.
After completion of therapy, patients were evaluated with symptoms score, otoscopic picture, change in the adenoid size, PTA and tympanometry. The quality of life was assessed by using Glasgow Children’s Benefit Inventory in each case at V2 visits .
2.1
Statistical Analysis
The observations were recorded on a pre-designed proforma and then transferred to MS Excel spreadsheet. After verification and cleansing, data analysis was done by using SPSS 19.0 software. The observations were described in terms of mean, median, standard deviation, and 95% confidence interval for continuous data. The quantitative data of symptoms, nasopharyngoscopic grade, tympanometric analysis between two groups were compared by using student’s ‘t’ test. The qualitative data change in quality life between two groups was compared by using chi-square test/Fisher exact test. A p value < 0.05 was considered as cut off point for level of significance.
2
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 with duration of symptoms for at least 3 months and not responsive to previous medical treatment were enrolled. The exclusion criteria were: 1) previous adenoidectomy, 2) use of intranasal topical or systemic steroid in last 1 year, 3) associated marked tonsillar hypertrophy, 4) anatomic deformity of the nose or sinonasal disease such as nasal polyposis or inferior turbinate hypertrophy, 5) craniofacial abnormalities such as cleft lip/cleft palate, 6) genetic diseases such as Down Syndrome, 7) acute upper respiratory infection within 2 weeks of enrolling in the study, and 8) patients with any clinically significant metabolic cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease.
Detailed history and ENT examination including pneumatic otoscopy were done at Vo. Clinical grading of symptom score was done ranging from 0 to 3 (0 = absent; 1 = occasional; 2 = frequent; 3 = daytime and night-time symptoms) to assess the degree of nasal obstruction, rhinorrhoea, cough, snoring and obstructive sleep apnoea at baseline (V0), 8(V1) and 24(V2) weeks visits. These patients were subjected to tympanometry, pure tone audiometry (PTA) wherever possible and nasopharyngoscopy under local anaesthetic spray (lignocaine spray 15%)/sedation with midazolam if required using rigid 2.7 mm/4 mm diameter nasal telescope. The endoscopy was videotaped and stored by AIDA (Advanced Interface Database Application) and still photographs were taken from the video ( Fig. 1 ). The grading of adenoidal hypertrophy was noted as described by Cassano et al. .
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