Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
- Conditions
- Retinopathy of PrematurityDexmedetomidine
- Interventions
- Drug: Saline
- Registration Number
- NCT06067958
- Lead Sponsor
- Assaf-Harofeh Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams
- Informed consent signed by one of the parents
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Saline Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination Dexmedetomidine Dexmedetomidine Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination
- Primary Outcome Measures
Name Time Method The Premature Infant Pain Profile: Revised, at peak 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.
- Secondary Outcome Measures
Name Time Method Duration of examination Up to 30 minutes The time between the insertion and the removal of the retractor
Bradycardia From time 0 until 5 hours after the examination Number of bradycardias, defined as a drop of 20% from baseline heart rate
Heart rate Assessed every hour from time 0 until 5 hours after the examination The average heart rate of the infant
Percent of crying time The duration of the video recording (up to 1 hour) The percent of time in which the participant cried during the video recording
The Premature Infant Pain Profile: Revised, 5 minutes 5 minutes 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.
For this secondary outcome, PIPP-R score 5 minutes after the insertion of the retractor will be assessed.The Premature Infant Pain Profile: Revised, at completion 2 minutes after the removal the retractors 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.
For this secondary outcome, PIPP-R score 2 minutes after the after the removal the retractors will be assessed.Apnea From time 0 until 5 hours after the examination Number of apneas or desaturations \< 90%
Trial Locations
- Locations (1)
Assaf-Harofeh Medical Center
🇮🇱Be'er Ya'akov, Center, Israel