Actively Recruiting
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Led by Assaf-Harofeh Medical Center · Updated on 2024-12-06
30
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age less than 31 weeks post-menstrual age or birth weight less than 1500 grams
- Signed informed consent from one parent
You will not qualify if you...
- Infant on invasive ventilation at the time of eye exam
- Multiple congenital anomalies
- Chromosomal or genetic anomalies
- Received sedative drug within last 5 days
- Eye exam for reasons other than retinopathy of prematurity screening
- Attending physician considers infant not stable enough
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Assaf-Harofeh Medical Center
Be’er Ya‘aqov, Center, Israel, 7033001
Actively Recruiting
Research Team
S
Sagee Nissimov, MD
CONTACT
I
Iris Morag, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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