combination of intravenous fentanyl and ketamine vs intravenous fentanyl for analgesia during laser photocoagulation in retinopathy of prematurity in preterm neonates: A randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Proportion of neonates having adequate pain relief defined as PIPP R score less than 7 for at least fifty percentage of the time during the procedure
研究概览
简要总结
Any preterm neonate more than 1500 gm requiring retinopathy of prematurity screening found to have zone 2 ROP planning for laser photocoagulation, meeting the inclusion criteria will be enrolled in this study after obtaining informed written consent from the parents. If consented babies will be randomised to one of the two arms (fentanyl and ketamine Vs fentanyl). Before the procedure non pharmacological measures, along with local anaesthetic eyedrops will be instilled. Baseline PIPP-R score will be done and bolus dose of the drugs will be given as per the arms chosen by randomisation. During the laser the drugs will be titrated as per the PIPP-R score, and baby will be continuously monitored throughout the procedure until discharge for any adverse events and will be managed with appropriate measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 28.00 Day(s) 至 8.00 Month(s)（—）
- 性别
- All
入选标准
- •All preterm neonates more than 1500g at the time of screening on room air for past 3 days and hemodynamically stable requiring laser photocoagulation for zone 2 ROP.
排除标准
- •Major malformations severe birth asphyxia shock Known chromosomal abnormality History of chest wall rigidity with fentanyl by screening the records History of any opioid use in the last 7 days Known hydrocephalus or glaucoma.
结局指标
主要结局
Proportion of neonates having adequate pain relief defined as PIPP R score less than 7 for at least fifty percentage of the time during the procedure
时间窗: 5 minutes prior to the procedure and then every 15 minutes during the procedure
次要结局
- To determine the side effect profile of combination of fentanyl infusion and intermittent ketamine bolus(All the apneic events will be recorded)
- To determine occurrence of feed intolerance(Two hourly till twelve hours post procedure)
- To determine requirement of ventilatory support(From the start of procedure to twenty four hours after the procedure)
- To determine occurrence of urinary retention(six hourly till twenty four hours post procedure)
- To determine occurrence of hemodynamic instability within twenty four hours of procedure(Two hourly till twelve hours post procedure)
研究者
Bairapaga Harshini
All India Institute Of Medical Sciences, New Delhi