A Randomized Clinical Trial of Buzzy Versus Vapocoolant in Pain Relief During Phlebotomy and IV Catheterization in the Pediatric ED
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
研究概览
简要总结
The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Need IV's line placement for IV fluids and/or phlebotomy
排除标准
- •patients sensitive to cold i.e. Raynaud's
- •critically ill patients
- •mentally challenged patients
- •Patient with altered sensation
- •Patients needing more than one attempt at IV placement
研究组 & 干预措施
Vapocoolant
Will have nurse spray vapocoolant on the skin before IV insertion, will then videotape patient and ask them and parent to fill out FACES form.
干预措施: Vapocoolent (Drug)
Buzzy Bee
Will have nurse put Buzzy Bee on arm before, and leave it on during IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.
干预措施: Buzzy Bee (Device)
Placebo
Will have nurse place a rubber band around arm before IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.
干预措施: Placebo (Other)
结局指标
主要结局
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
时间窗: post intervention
Wong- Baker Faces Pain Scale with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. The changes in pain between the treatment groups were analyzed using chi square and one-way ANOVA for categorical and continuous variables respectively. Pre and post FACES pain scale-revised were reported as means and standard deviations
Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver
时间窗: post intervention
Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.
次要结局
未报告次要终点
研究者
Jill C Fennell
Pediatric Emergency Medicine Fellow
State University of New York at Buffalo