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临床试验/NCT00882960
NCT00882960Unknown4 期

Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management

Genesys1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
500
试验地点
1
主要终点
The primary measure will be the change recorded in patients subjective pain using a standardized scale

研究概览

简要总结

Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.

详细描述

Currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. Often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. The lack of delivery method than prevents the patients from receiving humane and indicated pain medication. In patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions.

The goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. The medication to be administered will be Fentanyl, a previously established and approved pre-hospital analgesic medication. As with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. Specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration

The study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. We will ask participants to quantify their pain using the Wong-Baker FACES pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. The drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.

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
None

入排标准

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

入选标准

  • •Persons who meet the current State of Michigan County of Oakland and County of Genesee pre-hospital pain requiring analgesia.
  • •Examples of these patients would be those with fractures, kidney stones, or traumatic injuries, burns.

排除标准

  • •Patients who have compromised nasal pharynx such as those who have obvious fractures or epistaxis.
  • •Additionally patients who are in the supine position for cervical spine immobilization will be excluded.

研究组 & 干预措施

2

Active Comparator

patients who are randomized to receive intra-nasal fentanyl for control of their pain

干预措施: intra-nasal fentanyl (Drug)

1

Active Comparator

patients who are randomized to receive intravenous fentanyl for control of their pain

干预措施: intravenous fentanyl (Drug)

结局指标

主要结局

The primary measure will be the change recorded in patients subjective pain using a standardized scale

时间窗: Pain will be assessed at 5 and 10 minutes post administration of Fentanyl

次要结局

  • Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl(5 and 10 minutes post medication delivery)

研究者

发起方
Genesys
申办方类型
Other

研究点 (1)

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Intranasal Fentanyl for Pain Management | 临床试验