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

0096-23-ASF

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.

2024-01-01

2024-12-01

2025-04-01

Not yet recruiting

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a crossover, prospective randomized controlled trial. Block randomization will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "The units pharmacologist will be responsible for patient assignment and preparation of the medication / placebo syringes but will remain blinded to the other aspects of the trial. The patient's nurse, attending physician, ophthalmologist, investigator and outcome assessor will remain blinded to the patient allocation", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-12-08