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临床试验/NCT05296187
NCT05296187已完成不适用

Efficacy of Transcutaneous Electrical Acupuncture Point Stimulation (TEAS) for the Prevention of Propofol Injection Pain in Children

Konya Meram State Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2025年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain with propofol injection

研究概览

简要总结

The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.

详细描述

Pain from the injection of propofol is a common side effect during anesthetic practice. Various methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing propofol injection pain in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I-II and aged 6-13 years patents who will undergo elective surgery under general anesthesia

排除标准

  • patients with propofol allergy
  • patients who have renal, hepatic, cardiac, neurological, psychiatric disease
  • Cardiac and cranial surgery
  • Pacemaker,
  • Emergency surgery and patients requiring rapid serial induction

研究组 & 干预措施

GROUP TEAS

Active Comparator

Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6).

干预措施: TEAS (Device)

Control Sham Group

Placebo Comparator

Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation.

干预措施: TEAS (Device)

结局指标

主要结局

Pain with propofol injection

时间窗: 5 minutes

pain will be assessed using a four point behavioral scale: 1= no pain (no reaction); 2= mild pain (grimace); 3= moderate pain (grimace+cry); 4= severe pain (cry+withdrawal)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

研究点 (2)

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