Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4+
SponsorAssaf-Harofeh Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams
Informed consent signed by one of the parents
Disqualifiers
Invasive ventilation at the time of the eye assessment
Multiple congenital anomalies
Chromosomal / genetic anomalies
Infant received a sedative drug in last 5 days
Trial design
Design model
Crossover
Treatments tested in this trial
Dexmedetomidine
DrugIntranasal 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.
Saline
DrugIntranasal 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: DexmedetomidineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The 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 retractorSecondary outcomes
1
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 retractor2
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 retractors3
Apnea
Number of apneas or desaturations \< 90%
Time frame
From time 0 until 5 hours after the examination4
Bradycardia
Number of bradycardias, defined as a drop of 20% from baseline heart rate
Time frame
From time 0 until 5 hours after the examinationSponsors and contacts
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Source ClinicalTrials.gov