Intranasal Dexmedetomidine for Pain Relief During Retinopathy of Prematurity Screening in Preterm Infants <30 Weeks Gestation Using Standard Drug Combination

2 1 1

What is this study about?

Retinopathy of prematurity is a condition that can affect the eyes of babies born very early, potentially leading to vision problems. During routine eye examinations, several eye‑drop medicines are used to widen the pupil and numb the eye, including oxybuprocaine, phenylephrine and cyclopentolate. In this study a single dose of dexmedetomidine given through the nose, or a matching sodium chloride solution (placebo), is added to the usual eye‑drop regimen before the exam.

The aim is to find out whether the nasal dose of the study drug reduces the pain measured by the Premature Infant Pain Profile‑Revised during the first 30 seconds after the eye speculum is placed. Infants are randomly assigned to receive either the study drug or the placebo, then undergo the standard eye screening while pain scores and basic vital signs are recorded. After the exam the infants continue to be observed for a short period to monitor any breathing changes, oxygen needs, crying, sleep, or other reactions before returning to regular care.

1 initial registration and randomisation

after you agree to join the study, basic information such as weight and gestational age is recorded.

you are assigned to receive either intranasal dexmedetomidine or a placebo (0.3 ml sodium chloride solution) without knowing which one.

2 pre‑exam eye‑drop preparation

the care team prepares three eye‑drop solutions that are part of standard care:

oxibuprokain eye drops (1.2 mg per dose),

phenylephrine eye drops (150 µg per dose), and

cyclopentolate eye drops (150 µg per dose).

each drop is applied to the infant’s eyes according to the protocol before the screening exam.

3 administration of the study medication

once the eye drops are in place, the assigned study medication is given intranasally.

if you are in the active group, the dose is dexmedetomidine 2 µg per kilogram of body weight delivered as a nasal spray.

if you are in the placebo group, you receive 0.3 ml of sodium chloride solution intranasally.

the medication is given once for each screening session.

4 screening eye examination and pain monitoring

the ophthalmologist performs the retinopathy of prematurity screening using a speculum.

pain is assessed during the first 30 seconds after the speculum is inserted using the premature infant pain profile‑revised (pipp‑r) score.

additional observations such as heart rate, respiratory rate, oxygen saturation, and any cardiorespiratory events are recorded.

5 post‑exam observation and follow‑up

after the speculum is removed, pain is assessed again with the pipp‑r score.

the infant is observed for at least one hour to monitor heart rate, breathing, oxygen needs, cry duration, sleep time, vomiting episodes, and any changes in respiratory support.

all observations are entered into the study database.

Who Can Join the Study?

  • Infants born early (before 30 weeks of pregnancy, known as gestational age <30 weeks) who will have the regular eye exam for retinopathy of prematurity (ROP) screening and whose parents have signed the permission form for the study.

Who Cannot Join the Study?

  • Received any medication for sedation or pain (except sugar water) within the last 24 hours before the eye exam; this includes pharmacological sedation/analgesia.
  • Has a severe brain bleed called intraventricular hemorrhage that is classified as grade 3‑4.
  • Has abnormal brain development, known as cerebral malformations.
  • Has a heart problem present from birth, referred to as congenital heart disease.
  • Has an irregular heartbeat, known as arrhythmia.
  • Is currently on a breathing machine (mechanical ventilation) or needs medication to keep blood pressure up (vasopressor) at the time of the exam.
  • Has any nose shape or blockage that could interfere with giving the medicine through the nose (nasal anatomical abnormalities).
  • Is allergic or has a strong reaction to dexmedetomidine or any of its inactive ingredients (excipients).
  • Has low blood pressure that is not being controlled (uncontrolled hypotension).
  • Has a recent serious brain blood‑vessel problem (acute cerebrovascular condition) that is not already listed above.
  • Has a slow heart rate (bradycardia) that is not caused by a temporary issue like a breathing pause.
  • Has very poor liver function, described as severe hepatic impairment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
01.09.2026

Trial locations

Oxybuprocaine eye drops are a local anesthetic that is applied to the surface of the eye. In the trial they are used to numb the eye before the retinopathy of prematurity screening, helping to make the eye exam more comfortable for the baby.

Phenylephrine eye drops are a medication that makes the pupil of the eye larger. In the study they are given before the eye exam so the doctor can see the retina more clearly during the screening.

Cyclopentolate eye drops also cause the pupil to widen and relax the eye’s focusing muscles. They are used together with other eye drops to keep the pupil open for a clear view of the retina during the screening procedure.

Dexmedetomidine is a medication that can calm and reduce pain. In this trial it is given through the nose (intranasally) to preterm infants before the eye screening, with the goal of lowering the pain they feel compared to the standard care alone.

Investigated diseases:

Retinopathy of prematurity – Retinopathy of prematurity is an eye condition that affects babies born very early. It begins when the small blood vessels in the retina grow irregularly. Over weeks, these vessels may leak fluid or form scar tissue that can pull on the retina. The disease can move from mild, harmless changes to more extensive abnormal vessel growth. Watching the retina over time shows how the condition progresses.

Trial ID:
2023-507975-23-01
Protocol code:
DEX2025
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on Oral Propranolol for Preventing Severe Retinopathy in Premature Infants

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany
  • Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Germany