Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- SN-5 at one year post procedure
研究概览
简要总结
The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. The Sinus and Nasal Quality of Life Survey (SN-5), a validated tool, will be used to track symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent an improvement in symptom control. In this study, the SN-5 at one year post intervention will be the primary endpoint. Secondary endpoints include complications, revision surgery, and post operative endoscopy scores.
详细描述
Indications for surgery for pediatric chronic rhinosinusitis currently lacks scientific consensus. In general, children who fail medical management are candidates for surgery. Currently, pre-operative evaluation with a CT scan of the sinuses is the gold standard prior to sinus surgery. However, the role of the adenoids and adenoiditis in pediatric chronic sinusitis is incompletely understood. Adenoids may contribute to sinusitis both as a bacterial reservoir and obstruct nasal secretion drainage, owing to their larger relative size in children. Adenoidectomy alone has been found to improve symptoms in 75% of children.
It has been found that 50% of children continued to be symptomatic after adenoidectomy, and went on to require endoscopic sinus surgery (ESS). In addition, of the group that failed, 58% had asthma. Overall, asthma and age have been the only known risk factors for failure of adenoidectomy.
Specific Objectives The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. Outcomes will be evaluated using the SN-5, a validated tool used to track symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent an improvement in symptom control. In this study, the SN-5 at one year post intervention will be the primary endpoint. Secondary endpoints include complications, revision surgery, and post operative endoscopy scores.
Study Design
The primary outcome is the SN-5 score one year post surgery. A change of 0.5-1.0 is considered a mild improvement, while a change of at least 1.0 is considered a moderate improvement.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-12 at time of study enrollment.
- •Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough
- •Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
- •Failure of medical management of pediatric chronic rhinosinusitis, which current guidelines recommend extended empiric antibiotics for 21 days, which will be either Augmentin or clindamycin in penicillin allergic patients, at standard pediatric weight based dosing. In addition, Flonase nasal spray and nasal saline treatment for three weeks. Failure is considered persistent symptoms despite treatment with the above within the past year.
排除标准
- •Previous sinus surgery,
- •Previous adenoidectomy, or
- •Presence of cystic fibrosis,
- •Presence of antrochoanal polyp,
- •Immunodeficiency
- •Fungal infection.
结局指标
主要结局
SN-5 at one year post procedure
时间窗: One year
A validated tool used to track symptoms of pediatric chronic rhinosinusitis, improvement greater than 0.5
次要结局
- Revision/Alternate procedure, endoscopic sinus surgery(Two Years)
- Antibiotic use after surgical procedure(Two years)
- Complication Rate(Two Years)