Using intranasal dexmedetomidine to manage pain during eye exams in premature infants
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial
This study tests if a nasal spray of dexmedetomidine can help reduce pain for premature infants during eye exams.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 4 Weeks and up |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Be’er Ya‘aqov, Center) |
| Trial ID | NCT06067958 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intranasal dexmedetomidine for pain management in preterm infants undergoing eye examinations for retinopathy of prematurity. The study compares the pain scores of infants receiving dexmedetomidine to those receiving a placebo (saline 0.9%) administered 30 minutes prior to the examination. Participants will be closely monitored for pain relief and any potential adverse effects. The goal is to improve pain management during these critical assessments, which are known to cause significant discomfort.
Who should consider this trial
Good fit: Ideal candidates are preterm infants with a gestational age of less than 31 weeks or a birth weight of less than 1500 grams.
Not a fit: Patients who are on invasive ventilation or have multiple congenital or genetic anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and stress for preterm infants during necessary eye examinations.
How similar studies have performed: While there is limited data on the use of dexmedetomidine specifically for this purpose, similar approaches in pain management for infants have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Be’er Ya‘aqov, Center
- Assaf-Harofeh Medical Center — Be’er Ya‘aqov, Center, Israel (Recruiting)
Study contacts
- Study coordinator: Sagee Nissimov, MD
- Email: sageen@shamir.gov.il
- Phone: 97289779080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.