Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 28 days
Healthy Volunteers: f
View:

• Gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams

• Informed consent signed by one of the parents

Locations
Other Locations
Israel
Assaf-Harofeh Medical Center
RECRUITING
Be’er Ya‘aqov
Contact Information
Primary
Sagee Nissimov, MD
sageen@shamir.gov.il
97289779080
Backup
Iris Morag, MD
IRISMO@shamir.gov.il
97289778286
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Active_comparator: Dexmedetomidine
Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination
Placebo_comparator: Placebo
Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination
Sponsors
Leads: Assaf-Harofeh Medical Center

This content was sourced from clinicaltrials.gov