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临床试验/NCT01694745
NCT01694745已完成不适用

European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units

Hôpital Armand Trousseau240 个研究点 分布在 6 个国家目标入组 6,489 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,489
试验地点
240
主要终点
The frequency of ventilated neonates receiving sedation and analgesia in different European units

研究概览

简要总结

EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study.

The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries.

The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes.

The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception.

The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

详细描述

1.1 Background and rationale The alleviation of pain is a basic and human right regardless of age. Neonates do feel pain and it has been shown that preterm infants are even more vulnerable to pain than older infants. The more vulnerable preterm neonates are precisely those that are more exposed to pain. Neonates admitted to intensive care units, both neonatal intensive care unit (NICU) and pediatric intensive care unit (PICU), undergo dozens or even hundreds of painful procedures during their stay. These painful procedures include, for many of the ICU neonates, a tracheal intubation followed by mechanical ventilation. The pain and stress that are induced by mechanical ventilation as well as by repetitive procedures or painful diseases has led medical staff to use sedation and analgesia in neonates admitted to intensive care units. The subjectivity and difficulty inherent to pain measurement in neonates have probably contributed to a wide variety of neonatal sedation and analgesia practices. To date, these practices have been rarely studied.

Why would sedation and analgesia be necessary? Mechanical ventilation is a potentially painful intervention. Adults often describe mechanical ventilation as a painful and anxiety-provoking experience. The main objectives of sedation and analgesia are: reduction of pain, stress and irritability, promotion of blood pressure stability, promotion of ventilator synchrony and improvement of oxygenation. In the long term, reduced stress, as well as reduced fluctuations in oxygenation and blood pressure is believed to minimize the risks of neurological injury and death. However, the use of sedation and analgesia is only conceivable in the respect of the principle that must accompany all medical actions: first, do no harm.

Pain and stress undergone during the neonatal period can have deleterious short-term and long-term consequences. Some of these consequences have been reduced with adequate analgesic treatment. Current data show the necessity to give adequate sedation and analgesia to ventilated neonates.

Statements promoting the use of sedation and analgesia The increased awareness that neonates feel pain, the ethical obligation to treat this pain with analgesics, the growing body of evidence demonstrating that untreated neonatal pain can lead to altered reactivity to pain that persists throughout infancy and childhood as well as the need for a humane management of neonates have lead to the development of International and National Guidelines promoting the use of analgesics in the neonatal population. These Guidelines state that units that provide neonatal care should develop and implement guidelines concerning neonatal pain. However, the existing literature is still conflicting regarding the use of sedation and analgesia for ventilated neonates. Current data indicate that there is insufficient evidence to recommend the routine use of opioids in mechanically ventilated newborns and that opioids should be used selectively. Sedation and analgesia in non ventilated babies is extremely rare.

Practices across Europe and USA Data on sedation and analgesia practices in ventilated neonates are very rare. In 1995 the SOPAIN study carried out in the United States showed that factors predicting the use of on-going analgesia and sedation in neonates included: mechanical ventilation, higher gestational age, and male gender. In 2005, the French EPIPPAIN study showed that the rate of continuous sedation and analgesia was 69.6% in ventilated neonates with large variations among centers (16.7% to 90.9%). The most frequently used drugs were midazolam and morphine.

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

入选标准

  • • All neonates up to a corrected age of 44 weeks post conceptional. That means, for example, that an infant born at 40 weeks gestational age can be included up to 28 days (4 weeks) of post natal age or that a baby of 32 weeks gestational age can be included up to 12 weeks of post natal age.
  • NOTE: Since this is an observational epidemiological study, all eligible infants of the unit during the study period should be included.

排除标准

  • • The only exclusion criteria of this observational study is the participation of the neonate in a research study including a randomization for the use of sedative or analgesic drugs in ventilated neonates.

结局指标

主要结局

The frequency of ventilated neonates receiving sedation and analgesia in different European units

时间窗: one year

次要结局

  • The length of use of medications administered for sedation and analgesia in ventilated neonates(one year)
  • Similarities and differences in sedation and analgesia practices among European countries(one year)
  • The medications used for sedation and analgesia in ventilated neonates across Europe(one year)

研究者

发起方
Hôpital Armand Trousseau
申办方类型
Other
责任方
Principal Investigator
主要研究者

CARBAJAL

Professor

Hôpital Armand Trousseau

研究点 (240)

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