Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Premature Infant Pain Profile: Revised, at peak
研究概览
简要总结
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain.
Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.
The main questions it aims to answer are:
- Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).
- Does dexmedetomidine cause more adverse effects than placebo.
In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The units pharmacologist will be responsible for patient assignment and preparation of the medication / placebo syringes but will remain blinded to the other aspects of the trial. The patient's nurse, attending physician, ophthalmologist, investigator and outcome assessor will remain blinded to the patient allocation
入排标准
- 年龄范围
- 4 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams
- •Informed consent signed by one of the parents
排除标准
- •Invasive ventilation at the time of the eye assessment
- •Multiple congenital anomalies
- •Chromosomal / genetic anomalies
- •Infant received a sedative drug in last 5 days
- •Eye examination for reasons other than retinopathy of prematurity screening
- •Attending physician deemed the patient not stable enough
研究组 & 干预措施
Dexmedetomidine
Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination
干预措施: Dexmedetomidine (Drug)
Placebo
Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination
干预措施: Saline (Drug)
结局指标
主要结局
The Premature Infant Pain Profile: Revised, at peak
时间窗: PIPP-R score will be assessed 60 seconds after the insertion of the retractor
The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort. Every participant will be assessed using video recordings which will start 5 minutes before the administration of oral sucrose 24% and will continue until 5 minutes after the removal of the eyelid retractor. The primary outcome will be the PIPP-R score one minute after the insertion of the retractor.
次要结局
- Bradycardia(From time 0 until 5 hours after the examination)
- Heart rate(Assessed every hour from time 0 until 5 hours after the examination)
- Duration of examination(Up to 30 minutes)
- Percent of crying time(The duration of the video recording (up to 1 hour))
- The Premature Infant Pain Profile: Revised, 5 minutes(5 minutes after the insertion of the retractor)
- The Premature Infant Pain Profile: Revised, at completion(2 minutes after the removal the retractors)
- Apnea(From time 0 until 5 hours after the examination)
研究者
Sagee Nissimov
Principal Investigator
Assaf-Harofeh Medical Center