Publication date: Available online 5 January 2017
Source:International Journal of Pediatric Otorhinolaryngology
Author(s): A. Varricchio, A. De Lucia, A.M. Varricchio, A. della Volpe, N. Mansi, V. Pastore, G. Ciprandi
ObjectiveOtitis 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.MethodsThe 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.ResultsConsidering 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).ConclusionThe current randomized-controlled study demonstrated that Sinuclean Nebules was effective and in the treatment of children with OME.