Testing Intranasal Dexmedetomidine to Reduce Pain in Preterm Infants During Retinopathy of Prematurity Eye Screening A Phase 3 Crossover Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the use of intranasal dexmedetomidine to manage pain in preterm infants during routine eye examinations for retinopathy of prematurity, a condition requiring frequent monitoring. Current standard care, including sucrose and local anesthesia, does not fully relieve pain during these exams. This phase 3 crossover randomized controlled trial aims to determine if dexmedetomidine reduces pain scores compared to placebo and assess any differences in adverse effects. Participants will receive either intranasal dexmedetomidine at a dose of 2 micrograms per kilogram or a matching volume of saline 0.9% as a placebo, administered 30 minutes before their eye examination. Both treatments will be given using a nasal atomization device to both nostrils. This crossover design means each infant will experience both treatments at separate times, allowing comparison within the same participant. During and after the eye exams, infants will be closely monitored for up to 5 hours to observe any adverse effects such as apnea and bradycardia. Pain will be assessed using the Premature Infant Pain Profile Revised PIPP-R at multiple time points, including peak pain at 60 seconds after retractor insertion, 5 minutes after insertion, and 2 minutes after retractor removal. Additional measures include heart rate monitoring, duration of examination, and percentage of crying time recorded on video for up to one hour.

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity