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临床试验/EUCTR2018-002636-25-DK
EUCTR2018-002636-25-DK进行中(未招募)1 期

Highdose Steroid for High Pain Responders undergoing Total Hip-arthroplasty - A randomized doubleblindet controlled trial.

Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark.0 个研究点目标入组 160 人开始时间: 2018年8月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
160

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Age between 40 and 90.
  • - Booked for unilateral hip-arthroplasty.
  • - Is able to take part in the investigation(selfreporting of pain and nausea/vomitting)
  • - Understands Danish or English, or has a translator available.
  • - Chronic opioid-user with >29 mg morfine/day or equivalent other opioids and/or Pain Catastrophizing Scale-score of >20.
  • - Signatured written consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 120

排除标准

  • - Insulin-dependent diabetes melitus.
  • - Ongoing treatment with systemic glucocorticoids or immunesuppressing treatment(apart from inhaled glucocorticoids).
  • - Pregnancy/Breastfeeding
  • - Allergies for the investigational drug.
  • - A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

研究者

发起方
Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark.

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