Actively Recruiting

Phase 3
Age: 4Weeks +
All Genders
NCT06067958

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

Age: 4Weeks +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Assaf-Harofeh Medical Center

Be’er Ya‘aqov, Center, Israel, 7033001

Actively Recruiting

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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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Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity | DecenTrialz