Klonidin as pain relief in eye examination of infants born too early - 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: EUCTR2021-003005-21-SE

Lead Sponsor: Region Örebro län

Brief Summary: Not available

Detailed Description: Not available

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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). <br>- Evaluation of the safety of Clonidine in regards to AEs, SAEs and SUSARs. <br>- 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.;Timepoint(s) of evaluation of this end point: Evaluation during the two eye examinations.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - GSR: Area small peaks, area huge peaks, peaks per second och average rise time.<br>- Number of reported AEs, SAEs and SUSARS <br>- A VAS scale of 0-10 cm, from very easy to examin (0) to very difficult to examin (10);Timepoint(s) of evaluation of this end point: - GSR: values are collected within the first 30 seconds of the examination. <br>- AEs, SAEs are collected within 72 hours from the examination. <br>- VAS evaluation after the two eye examinations.