NCT03074968已完成4 期
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.
详细描述
- postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe
- scoring of pain with smartphone application (kids pain scale)
- incidence of use of rescue pain killer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •general anesthesia
- •intubation require
排除标准
- •recent upper airway infection
- •could not express the pain
研究组 & 干预措施
benzydamine hydrochloride
Active Comparator
Benzydamine Hydrochloride
干预措施: Benzydamine Hydrochloride (Drug)
control
Placebo Comparator
normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
pain
时间窗: 30 minutes in postanesthetic care unit
application based pain score
次要结局
未报告次要终点
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital
研究点 (1)
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