"Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - A double blind randomized control trial."
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- -To compare the effects of intranasal fentanyl (I) with standard care (C) in reducing procedural pain related to ROP screening (O) in preterm neonates (P) to be evaluated by the premature infant pain profile - R (PIPP-R) score
研究概览
简要总结
Retinopathy of prematurity (ROP) affects premature LBW infants. Early exposure to high ambient oxygen concentration appears to be a risk factor. systemic conditions like RDS, sepsis
, any kind of blood transfusion and anemia also play a key role. Nasal retina vascularizedafter 8 months of gestation and temporal after 1 month of delivery. Retinopathy of prematurity evolves through two phases. It begins with delayed vascular growth after premature birth (phase 1). Phase 2 follows when phase 1 induced hypoxia releases factor to stimulate new blood vessel growth. vascular epithelial growth factor (VEGF) is thought to play important role in this. genesis of ROP
Screening for ROP is an standard age-old practice in neonate ICU. Premature neonates experience a considerable amount of pain owing to speculum ROP screening from the insertion of a speculum, scleral indentation, and from the illumination of the ophthalmoscope. So here the pain are multimodal.(1) ROP screening produces short-lasting pain which is experienced mainly by non-ventilated neonates. The healthcare personnel have to depend on behavioral and physiological responses of neonates to grade the distress and pain cause during screening as they cannot verbalize their pain.
For the purpose of screening the pupil of the premature infants dilated with 0.8% tropicamide and 2.5% phenylephrine. topical anesthetics are installed and Topical anesthetic drop (proparacaine) is instilled before application of the neonatal eyelid eye speculum is used. Local anesthetic eye drops, swaddling, skin to skin care, gauge socked with expressed breast milk, non-nutritive sucking, have been evaluated in many clinical trials over past decade found to be inadequate effects on the pain associated with retinopathy of prematurity (ROP) screening. Meta-analyses study also concur that no single intervention was absolutely effective in reducing pain in ROP screening. The most optimal approach to relief the pain associated with retinal examination could be through engage in cluster of interventions, including analgesic medications. (1)
In pediatric patient Intranasal fentanyl is found to be safe and well-tolerated as analgesic method in pre-and post-operative pain control. The moa of fentanyl is it mainly acts through mu-opioid receptor. This route is a fast and easy way to achieve a clinically effective blood level
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •Preterm infants heaving gestational age <34 weeks or birth weight< 2000 gm were screened for retinopathy of prematurity.
排除标准
- •Unstable neonates ( ventilate) and sedated neonate Neonates with C/I for fentanyl Neonates planned for surgery and neonate with congenital defects, and neurological disfunction.
结局指标
主要结局
-To compare the effects of intranasal fentanyl (I) with standard care (C) in reducing procedural pain related to ROP screening (O) in preterm neonates (P) to be evaluated by the premature infant pain profile - R (PIPP-R) score
时间窗: immediately after screening,1 minute after screening,5 minute after screening
次要结局
- 1. . To compare the incidences of ocular and systemic side effect in neonates(due to intra nasal fentanyl) like apneic episodes, need of respiratory support and episodes of bradycardia & desaturation between the groups(2.To compare the time taken to complete the procedure successfully in both)