Sinuclean Nebules treatment in children suffering from otitis media with effusion. (March 2017)

• Record Type: Journal Article
• Authors: Varricchio, A.; De Lucia, A.; Varricchio, A.M.; della Volpe, A.; Mansi, N.; Pastore, V.; Ciprandi, G.
• Is Part Of: International journal of pediatric otorhinolaryngology. Volume 94(2017:Mar.)
• Page Start: 30
• Page End: 35
• Publication Date: 2017-03
• Subjects: Otitis media with effusion -- Cucurbitacines -- Children; Otolaryngology -- Periodicals; Pediatrics -- Periodicals; Otolaryngology -- Periodicals; Pediatrics -- Periodicals; Oto-rhino-laryngologie -- Périodiques; Pédiatrie -- Périodiques; 618.9209751
• DOI: 10.1016/j.ijporl.2017.01.001
• Languages: English
• ISSNs: 0165-5876

Abstract

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 < 0.0001). Conclusion: The current randomized-controlled study demonstrated that Sinuclean Nebules was effective and in the treatment of children with OME.