Clinical trial NCT06067958: Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Official title: Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Retinopathy of Prematurity
Dexmedetomidine
Keywords: Retinopathy of Prematurity
Dexmedetomidine
Pain
Analgesia
Premature Infant Pain Profile - Revised
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Premature Infant Pain Profile: Revised, at peak
timeFrame: PIPP-R score will be assessed 60 seconds after the insertion of the retractor
Secondary outcomes:
measure: The Premature Infant Pain Profile: Revised, 5 minutes
timeFrame: 5 minutes after the insertion of the retractor
measure: The Premature Infant Pain Profile: Revised, at completion
timeFrame: 2 minutes after the removal the retractors
measure: Apnea
timeFrame: From time 0 until 5 hours after the examination
measure: Bradycardia
timeFrame: From time 0 until 5 hours after the examination
measure: Heart rate
timeFrame: Assessed every hour from time 0 until 5 hours after the examination
measure: Duration of examination
timeFrame: Up to 30 minutes
measure: Percent of crying time
timeFrame: The duration of the video recording (up to 1 hour)
Other outcomes:
Locations:
city: Be'er Ya'akov
country: Israel
facility: Assaf-Harofeh Medical Center
state: Center
Study officials:
References:
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