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临床试验/NCT02803723
NCT02803723已完成不适用

"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants

Centre Hospitalier Universitaire de la Réunion0 个研究点目标入组 68 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
主要终点
Evolution of Pain

研究概览

简要总结

"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.

Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.

Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.

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
None

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Hospitalization at CHU de la Réunion - site sud in Neonatal Intensive Care Unit or Neonatology Unit. (Neonate reanimation, pediatric reanimation or Neonatology services)
  • Informed consent from holder(s) of the parental authority

排除标准

  • Intubated ou sedated patients
  • Treated with a combined analgesic during venipuncture
  • Having indications against sucrose
  • For which behavorial items from DAN scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)

结局指标

主要结局

Evolution of Pain

时间窗: At 0 and 30 seconds after the veinopuncture

Measure of pain by DAN scale at the time of the veinopuncture

次要结局

  • Pain at 1 min(1 min after veinopincture)
  • Cardiac Frequency(At 0 and 30 seconds after veinopuncture)
  • Oxygen saturation(At 0 and 30 seconds after veinopuncture)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

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