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临床试验/NCT01465984
NCT01465984已完成4 期

Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in pain severity/score

研究概览

简要总结

The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.

详细描述

Limb trauma is a painful condition that requires urgent analgesic treatment . Intravenous Opioids and NSAIDs are used extensively to control pain; both of them are with side effects. Paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than Morphine and NSAIDs, and approved as a safe and effective analgesic in emergency department.

recently Iv Paracetamol has become available in European countries and also in Iran.

efficacy and safety of IV Paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation.

Therefore, the investigators want to study the efficacy of IV Paracetamol in limb trauma and compare it with Iv Morphine sulfate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Clinical diagnosis of acute limb trauma
  • Age>=18 years
  • Acute pain of score 3 or greater on visual analogue scale

排除标准

  • Unstable hemodynamic (Systolic blood pressure under 90 mmHg)
  • Known sensitivity to opioids or paracetamol
  • Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction)
  • Previous administration of analgesic during 6 hours ago
  • Pregnant women
  • previous inclusion to the study
  • diagnosed heart failure
  • renal failure
  • pulmonary failure or hepatic failure

研究组 & 干预措施

IV Paracetamol

Experimental

干预措施: Paracetamol (Drug)

IV Morphine Sulfate

Active Comparator

干预措施: Paracetamol (Drug)

结局指标

主要结局

Change in pain severity/score

时间窗: after 30 minutes

次要结局

  • Need for rescue analgesia(After 30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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