NCT01543009暂停早期 1 期
Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 暂停
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- rate of success of peripheral venous cannulation at the first attempt
研究概览
简要总结
The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 8 and 13 years
- •Intravenous drug therapy prescribed by a physician
- •no allergy to lidocaine
- •no local skin disease
- •absence of burns scars
- •child and his/her family are native speaker of Italian
- •BMI not lower than 10° centile for sex and age according to the CDC standards
排除标准
- •age of child not included in the age range established for the study
- •Intravenous drug therapy not needed
- •Presence of an allergy to lidocaine products
- •Skin disease
- •Presence of burns scars
- •The child or his/her family are not native speaker Italian
- •BMI lower than 10° centile according to the CDC standards
结局指标
主要结局
rate of success of peripheral venous cannulation at the first attempt
时间窗: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
次要结局
- Time needed to obtain cannulation(From positioning tourniquet to completion of cannulation. No follow up is required)
- pain perceived by the child undergone to the cannulation(The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required)
- Difficulty in performing cannulation perceived by Nurse(The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required)
研究者
Filippo Festini
Professor of Nursing
University of Florence
研究点 (2)
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