Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency of sinusitis
研究概览
简要总结
Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.
详细描述
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks.Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell).
Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016
排除标准
- •Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation
- •Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
- •Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
- •Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
- •Patient who have mental retardation
- •Patient who have aminoglycosides hypersensitivity reactions
- •Pregnancy women and Lactation period
- •Patient who have abnormal hearing test before started gentamicin nasal irrigation
- •Patient who have chronic rhinosinusitis with nasal polyp
研究组 & 干预措施
Gentamicin
Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
干预措施: Gentamicin nasal irrigation (Drug)
Normal saline
Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
干预措施: Normal saline nasal irrigation (Drug)
结局指标
主要结局
Frequency of sinusitis
时间窗: During 1 year after treatment
次要结局
未报告次要终点
研究者
Nualanong Visitsunthorn
Department of Pediatrics Faculty of Medicine Siriraj Hospital
Mahidol University