Sinuclean Nebules treatment in children suffering from otitis media with effusion

Abstract Objective Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The current randomized, double-blind, controlled study aimed to evaluate whether Sinuclean Nebules treatment, administered by nasal...

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Bibliographic Details
Published in:International journal of pediatric otorhinolaryngology 2017-03, Vol.94, p.30-35
Main Authors: Varricchio, A, De Lucia, A, Varricchio, A.M, della Volpe, A, Mansi, N, Pastore, V, Ciprandi, G
Format: Article
Language:English
Subjects:
Administration, Intranasal
Audiometry
Child
Child, Preschool
Children
Cucurbitaceae
Cucurbitacines
Cucurbitacins - administration & dosage
Cucurbitacins - therapeutic use
Double-Blind Method
Female
Hearing Tests
Humans
Male
Nebulizers and Vaporizers
Otitis media with effusion
Otitis Media with Effusion - drug therapy
Otitis Media with Effusion - therapy
Otolaryngology
Pediatrics
Plant Extracts - administration & dosage
Plant Extracts - therapeutic use
Therapeutic Irrigation
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Summary:Abstract Objective Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The current randomized, double-blind, controlled study aimed to evaluate whether Sinuclean Nebules treatment, administered by nasal douche (Rinowash), could induce ear healing better than isotonic saline in children with OME. Methods The study was randomized, double-blind, and controlled. Group A (30 children) was treated with Sinuclean Nebules 45 and Group B (31 children) was treated with isotonic saline; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day in the morning and in the evening for 10 days, followed by a one-week suspension, and after by a second course as the first. Tympanogram and audiometry were performed at baseline and after treatment. Results Considering the global evaluation of the treatment: in Group A, 28 (93.3%) patients had complete resolution and 2 (6.7%) had partial resolution; in Group B, all patients had failure of treatment. There was a significant difference between groups (p 
ISSN:0165-5876
1872-8464
DOI:10.1016/j.ijporl.2017.01.001