Using intranasal dexmedetomidine to manage pain during eye exams in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of intranasal dexmedetomidine for pain management in preterm infants undergoing eye examinations for retinopathy of prematurity. The study compares the pain scores of infants receiving dexmedetomidine to those receiving a placebo (saline 0.9%) administered 30 minutes prior to the examination. Participants will be closely monitored for pain relief and any potential adverse effects. The goal is to improve pain management during these critical assessments, which are known to cause significant discomfort.

Why it matters

Who can join: the full rules

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

Where it's running

• Assaf-Harofeh Medical Center
  Be’er Ya‘aqov, Center, Israel Recruiting

Study contacts

• Study coordinator: Sagee Nissimov, MD
• Email: sageen@shamir.gov.il
• Phone: 97289779080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.