Combined Use of Buzzy and EMLA Cream for Vascular Access in Children. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Mean distress evaluated by parents
研究概览
简要总结
Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children.
The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure.
The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 4 and 12yrs of age needing venipuncture or peripheral vascular access
- •children who have applied EMLA cream at least 60 minutes before the procedure
排除标准
- •children with cognitive impairment
- •children with skin lesion that does not allow the application of Buzzy device
- •children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease)
- •children who have taken any analgesics in the 8 hours before enrollment
研究组 & 干预措施
Buzzy and EMLA Cream
In the experimental group children will receive the application of EMLA cream 60 minutes before the needle procedure and the use of Buzzy device during the procedure.
干预措施: Buzzy device plus EMLA cream (Device)
EMLA Cream
In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure
干预措施: Only EMLA cream (Drug)
结局指标
主要结局
Mean distress evaluated by parents
时间窗: Intraprocedural
Distress score will be recorded by parents through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
次要结局
- Mean pain score evaluated by parents(Immediately after the procedure)
- Mean pain score evaluated by operators(Immediately after the procedure)
- Success at first attempt(Intraprocedural)
- Mean distress evaluated by operators(intraprocedural)
- Mean pain score evaluated by children(Immediately after the procedure)