Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day.
研究概览
简要总结
The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV:
- Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;
- Group B) continuous infusion of placebo + open label boluses of Fentanyl.
详细描述
The primary objective of the study is to evaluate the analgesic superiority of Fentanyl given as 'continuous infusion + boluses' versus 'boluses alone' by comparing pain scores obtained by the application of validated algometric scales for chronic pain (EDIN - Echelle Douleur Inconfort Nouveau-Nè) and acute pain (PIPP- Premature Infant Pain Profile).
The secondary objective of the study is to evaluate the safety equivalence of the above 2 therapeutic regimens by recording:
- Rate of mechanically ventilated newborns at one week of age
- Age at which neonates will reach total enteral feeding
- Age (hours) of first meconium passage
- Incidence of intraventricular haemorrhage (IVH), periventricular leucomalacia (PVL) or death within 28 days of life
- Incidence of bladder globe during the first week of life
- Incidence of hypotension during the first week of life
5.2.1 Pain measurement: during the study phase acute pain will be measured once a day during a heel prick by a validated algometric scale for acute pain (PIPP); chronic pain will be measured 3 times a day by a validated algometric scale for chronic pain (EDIN). Inter-rater reliability has been shown acceptable for both scales (26,27). Moreover, in October 2006 the Coordinating Center organized a theoretical and practical course on the correct application of the PIPP and EDIN scales (26,27) for all the participating centers in order to reduce the inter-Center variability in pain measurement.
The EDIN scores will be recorded in a specific CRF (CRF N°1, p. 15). The PIPP scores will be reported in a specific CRF (CRF N° 1, pp. 8-14).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn neonates
- •preterm neonates ≤ 32+ 6 days weeks gestation
- •< 72 hours of life
- •newborns on MV
- •within 24 hours from the beginning of MV administered through an endotracheal tube
- •parental written informed consent for participation in the study must be obtained
排除标准
- •Evidence of severe birth asphyxia, that is an APGAR score below 4 at 5 minutes of age and/or umbilical arterial pH < 7.0
- •Known genetic or chromosomal disorders
- •Severe IVH (> grade II according to Volpe classification (30))
- •Need for post-operative analgesic therapy in the first week of life
- •Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol
研究组 & 干预措施
fentanyl
Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.
干预措施: Fentanyl (Drug)
placebo
Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary.
干预措施: 5% glucose solution (Drug)
结局指标
主要结局
The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day.
时间窗: 7 days
次要结局
- Rate of MVd newborns at one week of age;Age at which neonates will reach total enteral feeding;Age of first meconium passage;Incidence of IVH, PVL or death within 28 days of life;Incidence of bladder globe and hypotension during the first week of life(until discharge from hospital)
研究者
Ancora Gina
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna