Ahmed Ragab1, Taghreed Farahat2, Ghada Al-Hendawy3, Rehab Samaka4, Seham Ragab5, Amira El-Ghobashy3. 1. Department of Otorhinolaryngology, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt. Electronic address: drahmedragab@med.menofia.edu.eg. 2. Department of Pathology, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt. 3. Department of Family Medicine, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt. 4. Department of Microbiology, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt. 5. Department of Pediatrics, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt.
Abstract
OBJECTIVES:Acute rhinosinusitis (ARS) is a common pediatric problem. Our aim was to determine the efficacy of normal nasal saline irrigation (NSI) with or without amoxicillin in treatment of acute rhinosinusitis (ARS) in children. METHODS: It is a prospective randomized, blind placebo-controlled trial. Children with uncomplicated ARS were recruited. One group received (amoxacillin 100mg/kg/day) and 0.9% NSI. The second group received placebo and 0.9% NSI. The primary outcome was the effect of treatment on clinical response. Secondary outcomes included: Rating of Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), middle meatus (MM) bacteriological and cytological cellular responses and adverse effects. RESULTS:Sixty two patients with ARS were eligible for the study. In amoxicillin group (31 patients); clinical cure was observed in 26 (83.9%) in comparison to 22 (71%) patients in NSI without antibiotics group (31 patients) (p=0.22). No differences between both groups in the reported nasal symptom scores and total symptoms scores improvements at day 7 (p=0.09 and 0.65) and day 14 (p=0.29 and 0.14), respectively. The mean total PRQLQ values had no differences between both groups after the 2 weeks of treatment (p=0.06). At day 7, MM neutrophils reduced significantly in amoxicillin group in comparison to placebo group (p=0.004). At day 14, the MM cytological content had no differences between both groups (p=0.07). Normal NSI with placebo has less reported adverse effects than amoxicillin and nasal saline irrigations (p=0.005). CONCLUSIONS:NSI can be used alone with the same clinical, bacteriological and cytological cellular changes efficacy and with higher safety profile than amoxicillin after 14 days of treatment in uncomplicated clinically diagnosed ARS in children.
RCT Entities:
OBJECTIVES:Acute rhinosinusitis (ARS) is a common pediatric problem. Our aim was to determine the efficacy of normal nasal saline irrigation (NSI) with or without amoxicillin in treatment of acute rhinosinusitis (ARS) in children. METHODS: It is a prospective randomized, blind placebo-controlled trial. Children with uncomplicated ARS were recruited. One group received (amoxacillin 100mg/kg/day) and 0.9% NSI. The second group received placebo and 0.9% NSI. The primary outcome was the effect of treatment on clinical response. Secondary outcomes included: Rating of Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), middle meatus (MM) bacteriological and cytological cellular responses and adverse effects. RESULTS: Sixty two patients with ARS were eligible for the study. In amoxicillin group (31 patients); clinical cure was observed in 26 (83.9%) in comparison to 22 (71%) patients in NSI without antibiotics group (31 patients) (p=0.22). No differences between both groups in the reported nasal symptom scores and total symptoms scores improvements at day 7 (p=0.09 and 0.65) and day 14 (p=0.29 and 0.14), respectively. The mean total PRQLQ values had no differences between both groups after the 2 weeks of treatment (p=0.06). At day 7, MM neutrophils reduced significantly in amoxicillin group in comparison to placebo group (p=0.004). At day 14, the MM cytological content had no differences between both groups (p=0.07). Normal NSI with placebo has less reported adverse effects than amoxicillin and nasal saline irrigations (p=0.005). CONCLUSIONS: NSI can be used alone with the same clinical, bacteriological and cytological cellular changes efficacy and with higher safety profile than amoxicillin after 14 days of treatment in uncomplicated clinically diagnosed ARS in children.
Authors: F Scasso; G Ferrari; G C DE Vincentiis; A Arosio; S Bottero; M Carretti; A Ciardo; S Cocuzza; A Colombo; B Conti; A Cordone; M DE Ciccio; E Delehaye; L Della Vecchia; I DE Macina; C Dentone; P DI Mauro; R Dorati; R Fazio; A Ferrari; G Ferrea; S Giannantonio; I Genta; M Giuliani; D Lucidi; L Maiolino; G Marini; P Marsella; D Meucci; T Modena; B Montemurri; A Odone; S Palma; M L Panatta; M Piemonte; P Pisani; S Pisani; L Prioglio; A Scorpecci; L Scotto DI Santillo; A Serra; C Signorelli; E Sitzia; M L Tropiano; M Trozzi; F M Tucci; L Vezzosi; B Viaggi Journal: Acta Otorhinolaryngol Ital Date: 2018-04 Impact factor: 2.124