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临床试验/NCT00130650
NCT00130650已完成4 期

Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children

Children's Hospital of Eastern Ontario2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
2
主要终点
pain score

研究概览

简要总结

The purpose of this study is to investigate the use of a new vapocoolant spray, Pain Ease, to reduce intravenous (IV) insertion pain in school-aged children receiving treatment in the Emergency Department.

详细描述

Inserting a needle into a child's vein is a distressing experience for children. Reducing the pain of injection and avoiding the child's discomfort remains an important aim for both parents and health care workers. Withdrawing blood and intravenous insertion (IV) in children is also time consuming, especially when the child is uncooperative and stressed.

We, the researchers at Children's Hospital of Eastern Ontario, have been searching for an effective, rapid and inexpensive method to alleviate the distress associated with venipuncture and IV insertion.

Medications by mouth, such as anti-anxiety drugs, are helpful but usually do not significantly reduce the pain. The most commonly used anti-anxiety drug at our institution is midazolam, but unfortunately onset of action takes 20-30 minutes. There are various forms of topical creams that can numb the skin. EMLA, a mixture of two local anesthetics (Lidocaine 2.5% and Prilocaine 2.5%), is applied as a topical cream and is covered with an occlusive dressing. It requires at least 1 hour to be effective. It is not only time consuming but expensive (~$1.30 per application). Ametop (Tetracaine PH. Eur.4%w/w) is another effective topical cream, which works in 30 minutes, but it is more expensive than EMLA (~$3.00 per application). Vapocoolant sprays applied for ~10 seconds immediately before injection have been shown to be faster, less expensive and as effective as EMLA in reducing pain at the site of injection during immunization.

The current investigation will evaluate the quality, efficacy and costs associated with the use of a new vapocoolant spray, Pain Ease, in reducing pain associated with IV insertion for school age children.

研究设计

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

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 6-12 years old
  • Require an IV inserted in less than 30 minutes

排除标准

  • Allergy to vapocoolant sprays
  • Vascular impairment
  • Diabetes mellitus
  • Developmental delay/inability to understand pain scale
  • Received analgesia in last 24 hours
  • Triaged as resuscitation

结局指标

主要结局

pain score

时间窗: at injection (< 1 minute)

次要结局

  • anxiety score(at injectiong (< 1 minute))
  • satisfaction (nurse, parent)(<10 minutes post-injection)
  • IV insertion time(immediate)
  • ease of IV insertion(immediate)

研究者

申办方类型
Other

研究点 (2)

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