Klonidin as pain relief in eye examination of premature infants - cloROP

Phase 1

• Conditions: Pain during eye examination of premature infants.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2024-512438-14-00
• Lead Sponsor: Region Oerebro Laen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The infant is admitted to the study clinic, The infants guardian/s has/have given their written consent to the child's participation in the study, The infant is born before gestation week 30

Exclusion Criteria

Children who has received beta blockers, pain reliever or sedating drug within 24 hours of eye examination., Previously documented kidney failure, Does not have a gastric tube, Neurologically affected, Known cardiac arrhythmia, Circulatory instability (defined as mean arterial pressure lower than the child's gestational age)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to investigate whether clonidine works is a good analgesic during examination for Retinopathy of Prematurity (ROP);Secondary Objective: Change in emotional sweating Galvanic Skin Response (GSR), Evaluation of the safety of Clonidine in regards to AEs, SAEs and SUSARs, Will the infant be easier to examine by the eye doctor after receiving Clonidine?;Primary end point(s): PIPP-R scores within 30 seconds after the eye examination has been initiated, i.e. when the hooks are in place in the first eye in Uppsala or when the first eye is held open in Örebro.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):GSR: Area small peaks, area huge peaks, peaks per second och average rise time;Secondary end point(s):Number of reported AEs, SAEs and SUSARS;Secondary end point(s):A VAS scale of 0-10 cm, from very easy to examin (0) to very difficult to examin (10)