NCT00643838已完成3 期
Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers
Air Liquide Santé International1 个研究点 分布在 1 个国家目标入组 549 人开始时间: 2007年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 549
- 试验地点
- 1
- 主要终点
- Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
研究概览
简要总结
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anxious and/or phobic patients having a vomiting reflex
- •very young children requiring selective dental cares
- •mental deficient patient
- •patient having specific phobia linked to the dental care to be done
- •patient from 1 year old
- •ASA 1 or ASA 2 patient
- •existing of efficient contraception
排除标准
- •ASA 3 or ASA 4 patient
- •patient already treated without using Kalinox's sedation
- •patient already included in this protocol in a delay lower than 7 days
- •contraindication linked to the experimental product
- •Kalinox's inhalation duration higher than 1 hour
- •pregnant or breast-feeding women
研究组 & 干预措施
A
Experimental
Misture of 50% nitrous oxide and 50% oxygen
干预措施: Kalinox 170 bar (Drug)
结局指标
主要结局
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
时间窗: At the end of the dental care
次要结局
- Patient's acceptance and doctor's satisfaction(At the end of dental care)
研究者
研究点 (1)
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