Epidémiologie Des Gestes Douloureux ou Stressants Chez Les Nouveau-nés Pris en Charge Dans Les unités de réanimation néonatale et pédiatrique et Par Les équipes de SMUR de la région d'Ile de France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 21
研究概览
简要总结
Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years.
Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared.
The objectives of the present study are:
- To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale.
- To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011.
- To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France.
- To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units
- To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units
- To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results
详细描述
STUDY HYPOTHESIS
Principal hypothesis
- The number of painful and stressful procedures performed in the neonate admitted to intensive care units is still very high but it is lower than in 2005 Pain scores are lower when procedures are performed with a specific analgesia prior to procedure.
Secondary hypothesis
- The frequency of pre-procedural analgesia is higher than in 2005
- Certain common procedures such as heel sticks and endotracheal intubations are carried out with a more frequent analgesia than in 2005
- The use of a continuous sedation and analgesia does not induce a reduction in specific pre-procedural analgesia
- A real-time pain assessment of painful procedures can be carried out in more than 80% of procedures performed in neonates in intensive care units Pain scores show that certain procedures which are apparently not very painful may elicit high pain scores in very sick neonates
- Certain procedures such as nursing care or weighing may induce high pain scores in neonates who have invasive tubes (endotracheal tubes, thoracic drainage)
- A continuous sedation and analgesia is given to more than 50% of ventilated neonates.
- Certain characteristics of neonates may influence the use of analgesics for painful procedures. Ex: gender, age, respiratory support
- Certain contextual characteristics or center may influence the use of analgesics for painful procedures. Ex: day or night, pain referent in the unit, night head nurse, written pain management guidelines.
- More than 80% of semi-urgent or non-urgent intubations are carried out with the use of premedication.
- Opioids are the most commonly drugs used for premedication during endotracheal intubations in neonates
- The assessment of intubating conditions and neonate tolerance show lower scores when intubations are performed with a premedication considered as "recommended" by the American Academy of Pediatrics
- The detailed observation of intubations in SMUR and intensive care units will enable initial validation of a tool assessment
- Too many capillary blood samples by heel sticks are carried out in neonates even in neonates that have normal values throughout repeated sticks.
- The frequency of blood gas assessments is widely variable among centers
- The frequency of capillary blood glycemia is widely variable among centers
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 45 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intensive care units:
- •Neonates admitted to the unit during the 6-week recruitment period
- •Age less than 45 post-conceptional weeks
- •Regional pediatric transport system (SMUR):
- •Neonates transported during the 2-months recruitment period
- •Age less than 45 post-conceptional weeks
排除标准
- 未提供
研究者
CARBAJAL
Professor
Hôpital Armand Trousseau