Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PIPP (Premature Infant Pain Profile)
研究概览
简要总结
Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.
详细描述
After randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. The sequence will be filmed. Evaluation of PIPP and DAN will be done after viewing by 3 independent experts. Each child will receive only one procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn from 28 weeks to 31 weeks +6 days GA.
- •Age from 0 to 48 hours of life.
- •Admission in intensive care unit or neonatal unit.
- •Need for more than 4 heel stick procedures per 24 hours.
- •One parents's consent
排除标准
- •Hemodynamic instability with initropic drug need.
- •Therapeutic Hypothermia in context of neonatal asphyxia.
- •Curarized child.
- •Neurologic anomaly of contact/tonus.
- •Lidocaine application during the 4 hours before the procedure
结局指标
主要结局
PIPP (Premature Infant Pain Profile)
时间窗: 15 sec before to 30 sec after heel-lance procedure
Behavioural measure of pain for premature infants. Indicators: * gestational age * behavioural state before painful stimulus * change in heart rate during painful stimulus * change in oxygen saturation during painful stimulus * brow bulge during painful stimulus * eye squeeze during painful stimulus * nasolabial furrow during painful stimulus
次要结局
- DAN (Douleur Aigue Nouveau-né)(15 sec before to 3 min after heel-lance procedure)