Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- pain evaluation
研究概览
简要总结
Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn
详细描述
After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn
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
- Single (Outcomes Assessor)
盲法说明
The statistician is not aware of the control and experimental arms, called arms A and B in the results he must analyze.
入排标准
- 年龄范围
- 2 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
- •Presence of sucking reflex
- •Patient whose authors of parental authority have given their written consent for their participation
- •Patient affiliated to or benefiting from a social security scheme
排除标准
- •Newborn intubated or NIV and / or sedated
- •Newborn with malformation (especially cleft palate)
- •Contra-indication to sugar administration
- •Newborn previously included in the study
- •Administration of analgesics in the previous 8 hours
- •Atresia of the unoperated esophagus
- •Non-operated oeso-tracheal fistula
- •Major swallowing disorders
- •Necrotizing ulcerative colitis
结局指标
主要结局
pain evaluation
时间窗: Time of nurse care - thirty minutes maximum
DAN SCALE
次要结局
未报告次要终点