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临床试验/NCT03638921
NCT03638921已完成2 期

35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Numerical Rating Scale (NRS)

研究概览

简要总结

MEOPA (Equimolar Oxygen-Nitrogen Protoxide Mix) is a gas used in emergencies for short-term painful acts. It is often very effective with an analgesic, anxiolytic and muscle relaxant action. It is often combined with other analgesic medicines. It has already been proven in emergency medicine for short-term pain and trauma. It seems that it could be used more particularly for pains of medical origin. A study has already proved its effectiveness in the treatment of migraines in emergencies. The first phase of the NEPHROPAIN study began in 2016 after a favorable opinion from the Regional Ethics Committee. NEPHROPAIN phase AVANT was a prospective non-interventional study on the use of analgesic drugs in nephritic colic in emergencies by Dr. Alexandre Tanneau. This study was conducted at the University Hospital of Rennes and included 60 patients admitted to the emergency department for suspected renal colic. It made it possible to recruit the control group of the NEPHROPAIN study. Its main objective was to describe the suspected population of renal colic in Rennes emergencies, to determine NEPHROPAIN's primary endpoint and the number of NEPHROPAIN needed subjects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

MEOPA

Experimental

Patients included in the study will receive MEOPA with a high concentration mask (bottle stored for at least 48 hours horizontally) at a minimum flow rate of 10 L / min under supervision of a health care worker after explanation of use to the patient in a quiet environment (box). MEOPA will be administered for a maximum total duration of 20 minutes, continuously or not depending on the needs of the patient, but after a continuous phase at the beginning of treatment of at least 3 minutes.

干预措施: MEOPA (Drug)

结局指标

主要结局

Numerical Rating Scale (NRS)

时间窗: 20 minutes

Pain Ealuation. Score : 0 to 10. Proportion of individuals whose initial pain evaluation (Digital Scale) is divided by at least two to T20.

次要结局

  • Hospitalization time(through hospitalizationcompletion, an average of a few hours)
  • Analgesics consumption(0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours))
  • Adverse effects related to taking analgesics,(through treatment completion, an average of a few hours)
  • NRS average(0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours))

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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