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临床试验/NCT03243006
NCT03243006已完成不适用

Effect of Early Analgesic Treatment on Opioid Consumption

University of Monastir0 个研究点目标入组 1,500 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
主要终点
use of rescue opioids

研究概览

简要总结

introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain.

objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years of age
  • a visual analog scale (VAS) equal to or higher than 30/100 ,
  • having given consent to participation
  • No contraindications to products used in the course of the study.

排除标准

  • having a vital distress that does not allow an adequate assessment of the intensity of the pain
  • an inability to assess pain intensity according to the VAS,
  • swallowing disorders or inability , or a contraindication or an allergy to the treatments used.

研究组 & 干预措施

group Placebo

Placebo Comparator

Patients in this group (Placebo Oral Tablet) received two placebo tablets

干预措施: Placebo Oral Tablet (Drug)

group Paracetamol

Active Comparator

Patients in this group received two 500 mg paracetamol tablets

干预措施: Paracetamol (Drug)

group Tramadol/Paracetamol combination

Active Comparator

Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)

干预措施: Tramadol/Paracetamol combination (Drug)

结局指标

主要结局

use of rescue opioids

时间窗: DURING emergency department stay

decreased consumption of intravenous morphine

次要结局

  • patient satisfaction(When quitting emergency department)
  • Length of emergency department stay(Until emergency department discharge)
  • Pain intensity at emergency department discharge(At emergency department discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

professor

University of Monastir

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