Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Study Overview
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Brief Summary
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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.

Official Title
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Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: A Crossover Randomized Controlled Trial

Conditions
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Retinopathy of Prematurity, Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams Informed consent signed by one of the parents Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This will be a crossover, prospective randomized controlled trial. Block randomization will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination | Drug: Dexmedetomidine<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination | Drug: Saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | PIPP-R score will be assessed 60 seconds after the insertion of the retractor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 minutes after the removal the retractors | 
| Apnea | Number of apneas or desaturations < 90% | From time 0 until 5 hours after the examination | 
| Bradycardia | Number of bradycardias, defined as a drop of 20% from baseline heart rate | From time 0 until 5 hours after the examination | 
| Heart rate | The average heart rate of the infant | 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 | Up to 30 minutes | 
| Percent of crying time | The percent of time in which the participant cried during the video recording | The duration of the video recording (up to 1 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinopathy of Prematurity, Dexmedetomidine, Pain, Analgesia, Premature Infant Pain Profile - Revised