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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Intranasal administration of dexmedetomidine will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
Intranasal administration of saline 0.9% will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
Assaf-Harofeh Medical Center
Be’er Ya‘aqov, Center, Israel
RECRUITINGThe Premature Infant Pain Profile: Revised, at peak
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.
Time frame: PIPP-R score will be assessed 60 seconds after the insertion of the retractor
The Premature Infant Pain Profile: Revised, 5 minutes
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.
Time frame: 5 minutes after the insertion of the retractor
The Premature Infant Pain Profile: Revised, at completion
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.
Time frame: 2 minutes after the removal the retractors
Apnea
Number of apneas or desaturations \< 90%
Time frame: From time 0 until 5 hours after the examination
Bradycardia
Number of bradycardias, defined as a drop of 20% from baseline heart rate
Time frame: From time 0 until 5 hours after the examination
Heart rate
The average heart rate of the infant
Time frame: Assessed every hour from time 0 until 5 hours after the examination
Duration of examination
The time between the insertion and the removal of the retractor
Time frame: Up to 30 minutes
Percent of crying time
The percent of time in which the participant cried during the video recording
Time frame: The duration of the video recording (up to 1 hour)
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