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临床试验/NCT02197546
NCT02197546已完成不适用

Acupuncture Reduces Pain and Autonomous Distress During Injection of Local Anaesthetic in Children - a Randomised Crossover Investigation

University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
2
主要终点
pain intensity

研究概览

简要总结

Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and distress in children receiving an injection of a local anaesthetic (LA). Children scheduled for dental treatment using local anesthesia as a standard treatment, received bilateral acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the patients stimulated the needles by massage. Two different treatment regimes were compared: a standardized LA injection given 5 minutes after acupuncture, and an LA injection without acupuncture. The order of treatment was randomised, with the two treatments performed on different days. Pain intensity during LA injection, assessed by the patient with the Verbal Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction with the received therapy were also recorded.

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
None

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children with an American Society of Anesthesiologists (ASA) physical status of I or II
  • scheduled for at least two dental treatments for caries requiring local anaesthesia

排除标准

  • history of analgesic medication, psychiatric disease, or local or systemic infection
  • necessity to change their treatment schedule

结局指标

主要结局

pain intensity

时间窗: 3 time points during one day of investigation

次要结局

  • pain intensity assessed by the parents and by physicians(4 time points during one day of investigation)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (2)

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