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临床试验/EUCTR2019-002844-25-DK
EUCTR2019-002844-25-DK进行中(未招募)1 期

Effect of Combinations of Paracetamol, Ibuprofen, and Dexamethasone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty. The RECIPE Randomized Clinical Trial - RECIPE

Daniel Hägi-Pedersen0 个研究点目标入组 1,060 人开始时间: 2019年9月26日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
1,060

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

  • Scheduled for elective, unilateral, primary total hip arthroplasty
  • BMI > 18 and < 40
  • Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
  • Give written informed consent to participate in the trial after having fully understood the contents of the protocol and restrictions
  • 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 424
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 636

排除标准

  • Patients who cannot cooperate with the trial
  • Concomitant participation in another trial involving medication
  • Patients who cannot understand or speak Danish
  • Patients with allergy to medication used in the trial
  • Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other
  • opioids including methadone and transdermal opioids.
  • Patients with daily use of systemic glucocorticoids (within 3 months before the trial)
  • Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure
  • (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (< 100 x 109/l); or against treatment with glucocorticoids
  • Dysregulated diabetes (investigator’s judgement)
  • Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement

研究者

发起方
Daniel Hägi-Pedersen

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