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临床试验/DRKS00025539
DRKS00025539招募中3 期

on-inferiority of TENS to analgosedation during lumbar puncture in children and adolescents - a prospective, controlled preference trial - LpTENS

Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, LMU Klinikum, LMU München0 个研究点目标入组 86 人开始时间: 2021年8月4日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
86

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
6 Years 至 17 Years(—)
性别
All

入选标准

  • Electively lumbar puncture with or without intrathecal administration of medication
  • Consent of the physician conducting the LP
  • Children six to 17 years who are able to operate the TENS device themselves (developed according to their age, no language barriers)

排除标准

  • Expected difficult LP due to anatomical characteristics (severe scoliosis, status after spinal surgery)
  • Obligatory premedication e.g. due to trauma experience
  • Diagnostic / therapeutic LP with CSF pressure measurement in cases of suspected or known pseudotumor cerebri
  • Contraindication to TENS (pacemaker, epilepsy)
  • Long COVID syndrome associated with elevated anxiety and hyperalgesia

研究者

发起方
Interdisziplinäre Schmerzambulanz, Campus Innenstadt, Klinik für Anaesthesiologie, LMU Klinikum, LMU München

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