跳至主要内容
临床试验/CTRI/2024/05/066746
CTRI/2024/05/066746尚未招募不适用

Pain assessment and management using nonpharmacological measures during surfactant administration by LISA vs INSURE technique

Department of Neonatology Government medical College Chh Sambhajinagar1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
To assess Pain profile during surfactant therapy with either LISA or INSURE method in preterm neonates diagnosed with RDS

研究概览

简要总结

Historically, pain in newborn babies has been under‐recognized and, consequently undertreated. It was not until the late 1980s that seminal studies of babies undergoing surgery convincingly demonstrated that even preterm neonates are sufficiently developed, both anatomically and physiologically, to experience and respond to noxious stimuli.Moreover, these studies showed that the responses to noxious stimuli could be attenuated by the use of anesthesia and analgesia. Prior to this, infants had been, for many years, subjected to major surgery with no, or minimal anesthesia and without postoperative analgesia. Still, it is probably fair to say that clinicians were slow to take this message on board.

There has been ongoing debate about whether receiving mechanical ventilation is a painful experience, but what is not any longer questioned is that the process of endotracheal intubation is painful and stressful. We cannot know exactly how infants subjectively perceive pain; the lack of self‐report in preverbal infants means that we can only extrapolate from information available to us about how older individuals experience different procedures. Endotracheal intubation is rarely performed in adults without the aid of analgesia and/or sedative medication. However, there are reports of necessary “awake” intubations in adults. Such a report describes the patient’s experience of the procedure: “It felt like I could not swallow, like I would suffocate on the fluid, like as I cough and throw up at the same time and then it burns”. This graphic description leaves the reader in no doubt that the procedure can be unpleasant. Neonates were routinely subjected to airway management and intubation without sedative drugs until relatively recently. A number of research studies have considered the use of premedication for intubation in the newborn population. A retrospective review found that the use of premedication facilitated intubation for operators of all levels of experience.7Randomized placebo‐controlled trials are few and have enrolled only small numbers of babies. Results are conflicting, with some demonstrating fewer attempts and reduced time to intubate with premedication, and another unable to show no benefit with the use of morphine versus placebo. There have also been multiple studies comparing different drugs and combinations of drugs that have not included a placebo group. While acknowledging the limitations in evidence and gaps in knowledge in this area, premedication has long been recommended for neonates undergoing intubation in all but emergency situations.

It had taken many years of research and education to reach a stage where the majority of neonatal units in developed countries had adopted the routine use of premedication for intubation, although practice has been varied with respect to the medication used. However, in recent years, manipulation of the airway in “awake” preterm neonates is again becoming accepted practice. How can this be, when evidence has pointed to better outcomes with the use of premedication? Less invasive surfactant administration (LISA) (also sometimes referred to as minimally invasive surfactant therapy (MIST)) has started to be used more readily, with more and more units adopting this approach. This involves the insertion of a fine catheter through the vocal cords of a spontaneously breathing infant, usually while maintaining noninvasive respiratory support during the procedure. Surfactant is administered through this catheter, which is removed immediately after to allow the baby to continue non‐invasive respiratory support. With the advent of this type of procedure, controversy has once again arisen around the concept of giving sedation and analgesia. Revised Premature infant pain profile( PIPP-R) is used routinely in assessment of pain during procedures in preterm neonates routinely which is valid and feasible.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 14.00 Day(s)(—)
性别
All

入选标准

  • All babies of GA less than 37 weeks with diagnosis of RDS requiring surfactant therapy with either LISA or INSURE methods.

排除标准

  • Intubation before the study entry
  • Perinatal asphyxia
  • IVH more than grade II.

结局指标

主要结局

To assess Pain profile during surfactant therapy with either LISA or INSURE method in preterm neonates diagnosed with RDS

时间窗: 1 Before surfactant administration | 2 During laryngoscopy | 3 During surfactant administration | 4 After the procedure

次要结局

  • Adequacy of analgesia(During surfactant therapy)

研究者

发起方
Department of Neonatology Government medical College Chh Sambhajinagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

John Biswas

Government medical college Chh. Sambhajinagar

研究点 (1)

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