80 Years of vision: preventing blindness from retinopathy of prematurity.
Edward H Wood, Emmanuel Y Chang, Kinley Beck...
https://pubmed.ncbi.nlm.nih.gov/33674712Actively Recruiting
Phase 3
Age: 4Weeks +
All Genders
ID06067958
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial
Led by Assaf-Harofeh Medical Center · Updated on 2024-12-06
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Who Can Participate
Age: 4Weeks +
All Genders
Eligibility Criteria
You may qualify if you...
- Gestational age less than 31 weeks post-menstrual age, or birth weight less than 1500 grams
- Informed consent signed by one of the parents
You will not qualify if you...
- Receiving invasive ventilation at the time of the eye assessment
- Multiple congenital anomalies
- Chromosomal or genetic anomalies
- Infant received a sedative drug in the last 5 days
- Eye examination for reasons other than retinopathy of prematurity screening
- Attending physician deemed the patient not stable enough
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Duration of each treatment administration corresponds to the timing before and during the eye examination visits.
Participants receive intranasal dexmedetomidine or saline before eye examinations to manage pain during retinopathy of prematurity screening.
2 treatment visits (in-person), one for each intervention in a crossover design
Trial Site Locations
Total: 1 location
1
Assaf-Harofeh Medical Center
Be’er Ya‘aqov, Center, Israel, 7033001
Actively Recruiting
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Research Team
S
Sagee Nissimov, MD
I
Iris Morag, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
International Classification of Retinopathy of Prematurity, Third Edition.
Michael F Chiang, Graham E Quinn, Alistair R Fielder...
https://pubmed.ncbi.nlm.nih.gov/34247850Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water.
Ramya Nayak, Kalale Nikhil Nagaraj, Girish Gururaj
https://pubmed.ncbi.nlm.nih.gov/31989459Physiologic effects of retinopathy of prematurity screening examinations.
Anita J Mitchell, Angela Green, Debra A Jeffs...
https://pubmed.ncbi.nlm.nih.gov/22123352Evaluation of retinopathy of prematurity screening in reverse Kangaroo Mother Care: a pilot study.
T R Padhi, D Sareen, L Pradhan...
https://pubmed.ncbi.nlm.nih.gov/25613847Neonatal pain and developmental outcomes in children born preterm: a systematic review.
Beatriz O Valeri, Liisa Holsti, Maria B M Linhares
https://pubmed.ncbi.nlm.nih.gov/24866853Long-term effects of neonatal pain.
Suellen M Walker
https://pubmed.ncbi.nlm.nih.gov/30987942Topical anesthesia or oral dextrose for the relief of pain in screening for retinopathy of prematurity: a randomized controlled double-blinded trial.
Saudamini V Nesargi, Suneetha Nithyanandam, Suman Rao...
https://pubmed.ncbi.nlm.nih.gov/25376189Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity.
Virginia A Marsh, William O Young, Kimberly K Dunaway...
https://pubmed.ncbi.nlm.nih.gov/15797982Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis.
Timothy Disher, Chris Cameron, Souvik Mitra...
https://pubmed.ncbi.nlm.nih.gov/29858451