A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
研究概览
简要总结
The purpose of this study is to the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation
详细描述
sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have more effective to decrease symptom in patient sinonasal disease when compare to normal saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of the various devices use in children with sinusitis. The purpose of this study was to compare the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation.
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
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 3-15 years
- •diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms > or = 10 days 2.
- •severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms
排除标准
- •patient who has history of penicillin allergy
- •patient who has complication of sinusitis
- •patient with a history of nasal anatomical defects
- •patient who has immune deficiency or primary ciliary dyskinesia
研究组 & 干预措施
syringe 20 ml
nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge
干预措施: syringe 20 ml (Device)
squeezable bottle
nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
干预措施: squeezable bottle (Device)
结局指标
主要结局
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
时间窗: compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment
For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment
次要结局
- the Contamination in Nasal Irrigation Devices(at second week after treatment)
研究者
araya satdhabudha
clinical professor
Thammasat University