Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Enrolling; Phase 3

Conditions: Retinopathy of Prematurity; Dexmedetomidine

Treatments: Drug: Saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06067958

0096-23-ASF

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 4+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination

Treatment:

Drug: Dexmedetomidine

Placebo

Placebo Comparator group

Description:

Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination

Treatment:

Drug: Saline