Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Clonidine Hydrochloride for Pain Relief During Eye Exams in Premature Infants with Retinopathy of Prematurity

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a medication called clonidine hydrochloride as a pain relief option during eye examinations for premature infants. The eye examination is specifically for a condition known as Retinopathy of Prematurity (ROP), which can affect the eyes of babies born before 30 weeks of pregnancy. The purpose of the study is to determine if clonidine can effectively reduce pain during these examinations.

In this study, some infants will receive clonidine, while others may receive a placebo. The medication is given orally, which means it is taken by mouth. The study will observe the infants during the eye examination to see how well the medication works in reducing pain. The researchers will look at different signs of pain and comfort in the infants to assess the effectiveness of clonidine.

The study will take place over a period of time, and the researchers will collect data on how the infants respond to the treatment. The goal is to find out if clonidine can be a helpful and safe option for managing pain during these important eye examinations in premature infants. The study is expected to continue until the end of 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The infant is admitted to the study clinic.

    The guardian(s) provide written consent for the infant's participation.

    The infant is born before gestation week 30.

  2. Step 2

    Medication administration

    The medication used in the study is clonidine hydrochloride.

    Clonidine is administered orally.

    The dosage, frequency, and duration of administration are determined by the study protocol.

  3. Step 3

    Eye examination

    The primary objective is to assess if clonidine provides effective pain relief during the eye examination for Retinopathy of Prematurity (ROP).

    The examination involves measuring PIPP-R scores within 30 seconds after the examination begins.

  4. Step 4

    Monitoring and evaluation

    Secondary evaluations include monitoring GSR (Galvanic Skin Response) and recording any adverse events.

    A VAS (Visual Analogue Scale) is used to assess the ease of examination, ranging from 0 (very easy) to 10 (very difficult).

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 31, 2026.

    The results will contribute to understanding the effectiveness of clonidine as a pain relief method during eye examinations in premature infants.

Who can join the trial?

3 criteria

  • The infant must be admitted to the study clinic.
  • The infant's guardian or guardians must have given their written consent for the child to participate in the study.
  • The infant must be born before **gestation week 30**. This means the baby was born before the 30th week of pregnancy.

Who cannot join the trial?

6 criteria

  • Infants who have any other serious health conditions that could affect their participation.
  • Infants who are taking other medications that might interfere with the study treatment.
  • Infants who have allergies to the study medication or its ingredients.
  • Infants who have had previous reactions to similar medications.
  • Infants whose parents or guardians do not agree to participate in the study.
  • Infants who are not in the age range specified for the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Klonidin is being studied to see if it can help reduce pain during eye examinations for premature infants. The trial aims to determine if this medication is effective as a pain reliever for these specific medical procedures.

What is already known about the treatment

Clonidine – Clonidine is administered orally or via injection and is currently being studied for its effectiveness in providing pain relief during eye examinations in premature infants. It is a well-established medication in medical literature, primarily used for treating high blood pressure and certain types of pain. The main therapeutic indication in this trial is to assess its analgesic properties for infants undergoing examinations for Retinopathy of Prematurity. At the molecular level, clonidine works by stimulating alpha-2 adrenergic receptors in the brain, which reduces the release of norepinephrine, leading to decreased pain perception. It is classified pharmacologically as an alpha-2 adrenergic agonist.

Investigated diseases

Pain during eye examination of premature infants – This condition refers to the discomfort experienced by premature infants during eye examinations, which are necessary to check for eye problems like Retinopathy of Prematurity (ROP). The pain can be caused by the use of instruments to hold the eyes open and the bright lights used during the examination. Infants may show signs of distress such as crying, increased heart rate, or changes in facial expression. The pain is typically acute and occurs during and shortly after the examination. Managing this pain is important to ensure the comfort and well-being of the infant during necessary medical procedures.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512438-14-00Estimated enrolment50 patientsSponsorRegion Oerebro Laen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.