NCT01125332终止3 期
Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- efficacity of local anesthetic
研究概览
简要总结
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces)
- •Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation.
- •Subjects girls or boys
排除标准
- •All the criteria dissuading the employment of a local anesthetic
- •Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp.
- •Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination.
- •Not consent of one of both holders of the parental authority
研究组 & 干预措施
group gel KY
Placebo Comparator
干预措施: Indirect laryngoscopy in the flexible nasofibroscope (Drug)
group gel lidocaine
Experimental
干预措施: Indirect laryngoscopy in the flexible nasofibroscope (Drug)
结局指标
主要结局
efficacity of local anesthetic
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.
次要结局
- pain's scale
研究者
研究点 (1)
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