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临床试验/NCT01022294
NCT01022294已完成不适用

Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

University of Aarhus1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Dental pain (pulp) threshold

研究概览

简要总结

To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip

详细描述

The present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles.

It is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA-groups I or II
  • 12-15 year of age
  • sound upper central incisors

排除标准

  • difficulties breathing through the nose
  • pregnancy
  • trauma to test teeth

研究组 & 干预措施

Arm 1

Experimental

Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session

干预措施: Nitrousoxide-oxygen and atmospheric air (Drug)

Arm 2

Experimental

Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session

干预措施: Atmospheric air; nitrousoxide-oxygen (Drug)

结局指标

主要结局

Dental pain (pulp) threshold

时间窗: During and after inhalation

次要结局

  • Muscle sensitivity to pressure(During and after inhalation)
  • Skin sensitivity ot electric stimulation(During and after inhalation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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