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临床试验/NCT01293058
NCT01293058已完成2 期

Study of Routs of Naloxone Administration for Opioid Overdosed Patients

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
level of consciousness

研究概览

简要总结

The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients

详细描述

In intravenous drug abusers (IDUs), as a result of previous intravenous substance abuse, the predictable difficult cannulate exist and cause the delay administration of antidote therapy. Additionally, IDUs are also at increased risk of carrying blood borne infections that could be transmitted to healthcare workers through needle stick injuries. The investigators aimed to compare intranasal administration of naloxone with intravenous route.

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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with the range of 15-50 years old
  • Who were suspicious to opioid overdoses based on history and having clinical appearance such as miotic pupils with loss of consciousness
  • Give response to naloxone with increasing the level of consciousness

排除标准

  • Not giving response to naloxone and suspicious to have another reason for loss of consciousness

研究组 & 干预措施

Intravenous

Other

The investigators administered intravenous naloxone for our opioid overdose patients

干预措施: Intravenous (Drug)

Intranasal

Other

The investigators administered intranasal naloxone for treatment of our patients

干预措施: Intranasal naloxone (Drug)

结局指标

主要结局

level of consciousness

时间窗: 4 min after naloxone administration

The investigators evaluated the level of consciousness with Glasgow coma sclae 4 minutes after naloxone administration

次要结局

  • blood pressure(at 4 min after naloxone administration)

研究者

申办方类型
Other

研究点 (1)

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