Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- # of participants with improved nasal obstruction score from baseline to 6 months
研究概览
简要总结
patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.
详细描述
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 3-16
- •obstructive sleep apnea warranting adenotonsillectomy
- •history of daytime nasal obstruction and or mouth breathing
- •failed medical treatment with either oral anti-histamine or nasal steroid spray.
- •turbinate hypertrophy on Physical Exam defined by >50% obstruction
排除标准
- •<3 or >16
- •unwillingness to comply with study procedures
- •congenital head and neck malformations, genetic syndromes, craniofacial anomalies
- •no evidence of turbinate hypertrophy or symptoms of nasal obstruction
- •pregnancy or breastfeeding
- •bleeding disorders
- •current therapy with coumadin or Pradaxa
结局指标
主要结局
# of participants with improved nasal obstruction score from baseline to 6 months
时间窗: baseline and 6 months
Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.
次要结局
未报告次要终点
研究者
Cristina Baldassari M.D.
Assistant Professor, Pediatric Otolaryngology
Eastern Virginia Medical School