Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Port Access Pain
研究概览
简要总结
The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.
Participants will receive either the spray or cream prior to port access and rate pain on a scale.
Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy
- •EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment
- •Previous allergic reaction or skin irritation due to EMLA
- •Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy
排除标准
- •Child has a legal guardian or non-parent family member as the only adult with them for the visit.
- •Children less than 4 years of age
- •Children with altered mental status
- •History of traumatic brain injury, developmental delay or autism
- •Child is nonverbal
- •Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take effect.
研究组 & 干预措施
Sterile Vapocoolant Spray
Num vapocoolant spray will be administered as a single use canister around the port
干预措施: Num Vapocoolant Spray (Drug)
EMLA Cream
Numbing (EMLA) cream will be applied around the port.
干预措施: EMLA Cream (Drug)
结局指标
主要结局
Port Access Pain
时间窗: Within 5 minutes of port access
Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.
Clinic Wait Time
时间窗: Day of visit, up to 8 hours
Wait time will be measured in minutes from check in to check out
Duration of Visit
时间窗: Day of visit, up to 8 hours
Total length of overall appointment time measured in minutes
次要结局
未报告次要终点
研究者
Marianne Hutti
Professor
University of Kentucky