Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Launched by ASSAF-HAROFEH MEDICAL CENTER · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called dexmedetomidine to help reduce pain in preterm infants during eye examinations for a condition known as retinopathy of prematurity. These eye exams can be very uncomfortable for these babies, and the usual methods of pain relief, like sugar water and local numbing medicine, often don’t provide enough relief. The trial aims to find out if dexmedetomidine can lower pain levels better than a placebo (a harmless saline solution) and to see if it has more side effects than the placebo.

To participate, infants need to be very premature (born before 31 weeks of pregnancy) or have a low birth weight (less than 1500 grams). Parents will need to give their consent for their baby to join. In this study, infants will receive either dexmedetomidine or the saline solution through their nose about 30 minutes before their eye exam, along with the usual pain relief methods. The babies will be closely monitored for five hours after the exam to check for any side effects, and researchers will use video recordings to assess their pain levels. This study is currently recruiting participants and is important for finding better ways to manage pain during these necessary medical procedures.

Gender

ALL

Eligibility criteria

• 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