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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Oerebro Laen	Orebro	Sweden
Unbiocr Uhyxjlefda Htuahhug	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	25.04.2022

Trial locations

Investigated drugs:

Clonidine Hydrochloride

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.

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 ID:

2024-512438-14-00

NCT ID:

NCT04902859

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?