Single dose intranasal fentanyl for the reduction of pain associated with screening for retinopathy of prematurity : a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 1.PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity
研究概览
简要总结
Standard pain relief measures used in neonates such as oral sucrose, oral paracetamol, proparacaine eye drops, EBM, non nutritive sucking , swaddling, KMC etc may be inadequate in relieving pain associated with screening for ROP.
Intranasal fentanyl is a standard analgesic used in children for severe pain.
We hypothesized that administration of fentanyl intranasally in addition to standard pain relief would result in a further 50 % reduction in Pain score (PIPP)in premature neonates undergoing ROP screening . 56 patients would need to be recruited for a study power of 90% and two tailed alpha of 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Day(s) 至 34.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates 30-34 weeks postmenstrual age undergoing screening for retinopathy of prematurity.
排除标准
- •1.Infant receiving sedation or analgesic medications for any reason.
- •2.Infants on mechanical ventilation.
- •3.Any congenital malformations, or neurological dysfunction.
- •4.Parents refusing consent.
结局指标
主要结局
1.PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity
时间窗: 1.PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity
次要结局
- 1.PIPP score during screening for retinopathy of prematurity(2.PIPP score post laser :time point 1,5,10 minutes post procedure)