Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pain intensity during ROP screening
研究概览
简要总结
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening.
Participants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.
详细描述
Retinopathy of prematurity (ROP) screening is an essential part of the care of preterm infants. Despite the routine use of standard comfort measures, the examination remains associated with moderate-to-high pain intensity scores in many infants. Repeated exposure to untreated or undertreated procedural pain in preterm infants has been associated with adverse short- and long-term effects, highlighting the need for additional evidence-based pain management strategies.
Intranasal fentanyl has several characteristics that make it a promising option for procedural pain management. It has a rapid onset of action, is easy to administer, avoids the need for intravenous access, and has been shown to be effective and well tolerated for procedural pain in older infants and children. Emerging neonatal evidence, including randomized controlled trials, suggests that intranasal fentanyl may reduce pain during ROP screening, but additional high-quality evidence is needed to establish its effectiveness and safety in preterm infants.
This randomized, double-blind, placebo-controlled clinical trial will evaluate whether intranasal fentanyl, when used in addition to standard comfort measures, reduces pain during routine ROP screening while maintaining an acceptable safety profile. The study is designed to provide high-quality evidence to help determine whether intranasal fentanyl should be considered as an additional option for pain management during this necessary neonatal procedure.
The findings from this study may help improve pain management for preterm infants undergoing ROP screening and contribute to future evidence-based clinical practice guidelines for neonatal procedural pain management.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a quadruple-masked (participant/family, care provider, investigator, and outcome assessor) randomized controlled trial. Blinding is maintained through pharmacy-controlled randomization and preparation of identical syringes containing either intranasal fentanyl or intranasal 0.9% normal saline placebo. Study drug and placebo are matched for volume, appearance, labeling, and administration method using a mucosal atomization device. Clinical staff administering the intervention, investigators, outcome assessors scoring PIPP-R from video recordings, and families remain unaware of treatment allocation throughout the trial. Allocation concealment is ensured by the institutional pharmacy, which maintains the randomization sequence and dispenses study medication according to assignment.
入排标准
- 年龄范围
- 30 Weeks 至 36 Weeks（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born ≤31 weeks gestational age and/or with birth weight <1250 g
- •Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care
- •Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support
- •Written informed consent obtained from a parent or legally authorized representative
排除标准
- •Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration
- •Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative/analgesic medications within 24 hours prior to the ROP examination
- •Known hypersensitivity or prior adverse reaction to fentanyl
研究组 & 干预措施
Intranasal Fentanyl Group
Participants in this group will receive intranasal fentanyl at a dose of 2 mcg/kg administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening. The study drug will be delivered via a mucosal atomization device into one nostril. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.
干预措施: Fentanyl Citrate (Intranasal) (Drug)
Placebo Group
Participants in this group will receive an equivalent volume of intranasal 0.9% normal saline placebo administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening using a mucosal atomization device. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.
干预措施: Normal Saline (Placebo, Intranasal) (Drug)
结局指标
主要结局
Pain intensity during ROP screening
时间窗: First 30 seconds after speculum insertion during ROP screening
Pain intensity will be measured using the Premature Infant Pain Profile-Revised (PIPP-R). The primary endpoint is the PIPP-R score during the first 30 seconds following speculum insertion during the ROP examination.
Pain intensity during ROP screening
时间窗: 30 seconds after speculum insertion during ROP screening
Pain intensity will be measured using the Premature Infant Pain Profile-Revised (PIPP-R) score. The score will be assessed 30 seconds after insertion of the speculum, during the ROP eye examination.
次要结局
- Proportion of infants with low to mild pain(During procedure and at 1- and 5-minutes post-procedure)
- Ongoing pain response during ROP screening(Every 30 seconds during the procedure)
- Pain recovery following ROP screening(1-minute and 5-minutes post-procedure)
- Cry duration(From speculum insertion through 5 minutes post-procedure)
- Salivary cortisol response(20 minutes pre-procedure and 20 minutes post-procedure)
- Adverse events(During the procedure and up to 4 hours post-intervention)
- Duration of ROP examination(During the procedure)
- Physiological responses(Baseline, during the procedure, and at 1- and 5-minutes post-procedure)
- Proportion of infants with low to mild pain(30 seconds after speculum insertion)
- Pain response during ROP screening(Every 30 seconds throughout the procedure)
- Salivary cortisol levels(Pre-procedure and 20 minutes post-procedure)
- Duration of ROP examination(Entire ROP procedure from speculum insertion to removal)
- Physiological pain indicators (Heart rate)(Baseline, 30 seconds after speculum insertion, 1-minute and 5-minutes post-procedure)
- Pain recovery following ROP screening(End of procedure, 1-minute and 5-minutes post-procedure)
- Cry time during and after procedure(During and after the ROP screening procedure)
- Adverse events related to intervention(During procedure and up to 4 hours post-intervention)
- Physiological pain indicators (RR)(Baseline, 30 seconds after speculum insertion, 1-minute and 5-minutes post-procedure)
- Physiological pain indicators (blood pressure)(Baseline, 30 seconds after speculum insertion, 1-minute and 5-minutes post-procedure)
- Physiological pain indicators (Oxygen saturation)(Baseline, 30 seconds after speculum insertion, 1-minute and 5-minutes post-procedure)
研究者
Marsha Campbell-Yeo
Clinician Scientist, Neonatal Nurse Practitioner, Professor
IWK Health Centre