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临床试验/EUCTR2021-005116-64-DK
EUCTR2021-005116-64-DK进行中(未招募)1 期

ow-dose ketamine as an adjunct to morphine for acute pain in the ED: a randomized, double-blinded, superiority trial

Aarhus University Hospital, Department of Anesthesiology0 个研究点目标入组 160 人开始时间: 2021年10月11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
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

  • 1) Emergency Department admission
  • 2) Age = 18 years
  • 3) NRS = 5
  • 4) Stable vital signs defined as systolic blood pressure = 90 mmHg, heart rate between 50 and 150 per minute, respiratory rate between 8 and 30 per minute, oxygen saturation greater than or equal to 92%.
  • 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 150
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • 1) Initial management by trauma-team
  • 2) Systolic blood pressure = 180mmHg, severe untreated arrhythmia, unstable angina, recent myocardial infarction (< 30 days), severe heart-failure (Ejection fraction < 40 %)
  • 3) Symptoms of untreated hyperthyroidism
  • 4) Cirrhosis with ascites
  • 5) Known/suspected pregnancy or breastfeeding
  • 6) Patients for whom consent is not obtainable or psychiatric forced treatment.
  • 7) Previously enrolled in the trial
  • 8) Psychiatric illness prior to admission defined as prior psychosis/schizophrenia
  • 9) Untreated diagnosed glaucoma
  • 10) Known hypersensitivity to ketamine or to any excipient or prior use of ketamine with a negative experience (i.e. hallucinations)
  • 11) Patient clearly influenced by drugs or alcohol

研究者

发起方
Aarhus University Hospital, Department of Anesthesiology

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