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

Qualifiers

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

Treatments tested in this trial

  • Dexmedetomidine
  • Saline

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators