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Otitis media with effusion (OME) is defined as effusion in the middle ear without signs and symptoms of an acute infection. It is a leading cause of hearing impairment in children, and its early and proper management can avoid hearing and speech impairment, which can cause developmental delay in children.Although many conditions such as enlarged adenoids, cleft palate, Down syndrome, Kartagener syndrome, and nasopharyngeal neoplasm are related to the role of eustachian tube (ET) dysfunction in the pathogenesis of OME, allergic, immunologic, and infectious factors have also been claimed. Treatment of OME is still a controversial issue, as conventional treatment approaches fail to provide satisfactory and permanent relief of otologic symptoms.There is lack of proven effectiveness of the commonly given treatments, such as antibiotics, decongestants, and antihistamines, which are potentially harmful and have disadvantages. Few in those studies,investigated topical intranasal steroid for OME treatment,and in those studies, the duration of intranasal steroid application was short and there was no hearing evaluation.
The aim of this study is to assess the efficacy of nasal steroids in management of OME by comparing its results with that of oral steroids and that of nasal saline spray.
Sixty patients (4-12) years aged children with OME over a period for two months will be included in this study. Informed written consent will obtained from the parents of patient studied after explanation of the research purpose.
Patient diagnosed clinically to have OME with type B tympanogram and conductive hearing loss will be enrolled in our study.
Exclusion criteria:
Tympanometry results were distinguished into four grades as classified by El-Anwar et al12: type A, normal curve (pressure 50/_99 H2O); type C1 (negative pressure _100/_199 mm H2O); type C2 (negative pressure _200/_394 mm H2O); type B (flat curve).2,3,11 The average hearing thresholds at 500 Hz and 1, 2, and 4 kHz were used in the statistical comparison.
Follow-up clinical examinations were done once per week for 3 weeks, at the end of treatment. The efficacy of nasal steroid for management of OME was compared with that of oral steroid and that of nasal sinomarin spray as placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| momestone furoate spray first group: will be given | Placebo Comparator | Nasonex spray one puff in each nostril daily for 8 weeks |
|
| prednisolone sodium phosphate 15mg second group: will be given | Placebo Comparator | Predsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks |
|
| hypertonic sea water solution spray third group: will be given | Placebo Comparator | Nasal spray one puff in each nostril daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate spray | Drug | Mometasone Furoate spray one puff in each nostril daily for 8 weeks hypertonic sea water solution spray one puff in each nostril daily for (8) weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical examination:Hearing loss | Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present, | 2 weeks evaluation for 2 months |
| Clinical examination:Nasal obstruction | Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present, | 2 weeks evaluation for 2 months |
| Full E.N.T history | Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss. | 2 weeks evaluation for 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muteea M Bakuwairi, master | Contact | 01148883026 | AssiutU | bakuwairi2017@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ezzat M Saleh, Professor | Assiut University | Study Chair |
| Mohamed M Abd ElNaeem, doctor | Assiut University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23855103 | Background | Yousaf M, Inayatullah, Khan F. Medical versus surgical management of otitis media with effusion in children. J Ayub Med Coll Abbottabad. 2012 Jan-Mar;24(1):83-5. | |
| 3932928 | Background | Bernstein JM, Lee J, Conboy K, Ellis E, Li P. Further observations on the role of IgE-mediated hypersensitivity in recurrent otitis media with effusion. Otolaryngol Head Neck Surg. 1985 Oct;93(5):611-5. doi: 10.1177/019459988509300508. |
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C009022 | prednisolone phosphate |
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| prednisolone sodium phosphate 15mg | Drug | three times per day for 1 week then gradual withdrawal over 2 weeks |
|
| hypertonic sea water solution spray | Drug | one puff in each nostril daily for 8 weeks |
|
| 2500860 | Background | Tomonaga K, Kurono Y, Chaen T, Mogi G. Adenoids and otitis media with effusion: nasopharyngeal flora. Am J Otolaryngol. 1989 May-Jun;10(3):204-7. doi: 10.1016/0196-0709(89)90064-1. |
| 9950108 | Background | Ho WK, Wei WI, Yuen AP, Hui Y, Wong SH. Otorrhea after grommet insertion for middle ear effusion in patients with nasopharyngeal carcinoma. Am J Otolaryngol. 1999 Jan-Feb;20(1):12-5. doi: 10.1016/s0196-0709(99)90045-5. |
| 1487659 | Background | Tang NL, Choy AT, John DG, van Hasselt CA. The otological status of patients with nasopharyngeal carcinoma after megavoltage radiotherapy. J Laryngol Otol. 1992 Dec;106(12):1055-8. doi: 10.1017/s0022215100121747. |