A Single Blinded Observational Study of the Effectiveness of a Pain Ease Local Anesthetic Spray, Combined With Ametop Gel, to Reduce the Discomfort of Intravenous Insertion
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pain-free IV insertion
研究概览
简要总结
The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.
详细描述
Purpose:
The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct to Ametop Gel™.
Hypothesis:
The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.
Objectives:
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 (Participant)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I & II
- •Elective day case procedure requiring an IV
排除标准
- •Planned IV insertion after inhalation induction
- •Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10
- •Ametop Gel™ application < 30 minutes before estimated IV start at time of screening
- •Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives
- •Patients receiving sedative pre-medication
- •Severe Needle phobia
研究组 & 干预措施
Comparator: Ametop only
Ametop Gel applied as sole topical anesthetic.
干预措施: Ametop (Drug)
Intervention: Pain Ease Cold Spray
Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.
干预措施: Pain Ease Cold Spray (Device)
结局指标
主要结局
Pain-free IV insertion
时间窗: intraoperative
The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale - Revised.
次要结局
- Insertion attempts(intraoperative)
- FPS-R pain score(intraoperative)
研究者
Stephan Malherbe
Associate Professor
University of British Columbia