Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Anxiety score
研究概览
简要总结
This study will compare the efficiency of the iPad distraction or the administration of Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children between 3 and 9 years old.
详细描述
The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.
The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.
All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Venous track needed
- •French mother tongue
- •Age between 3 and 9 years old
排除标准
- •Children with cognitive disorder (autism, metabolic disorders,
- •Children with cerebral-motor disability
- •Children who don't speak french
- •Children with ADHD treatment
- •Children with epilepsy
- •Children who present contraindication to the use of Nitrous oxide
研究组 & 干预措施
iPad distraction
Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time.
Intervention : game on iPad
干预措施: Games on an iPad (Other)
Nitrous Oxide
Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time.
Intervention : Nitrous Oxide
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Anxiety score
时间窗: From one hour prior to venous puncture until 1 hour afterwards
Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards. The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).
次要结局
- Pain score(From one hour prior to venous puncture until 1 hour afterwards)
研究者
Walid HABRE
Professor
University Hospital, Geneva