Klonidin as pain relief in eye examination of infants born too early - cloROP

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003005-21-SE

Enrollment

Registered

2021-06-24

Start date

2021-12-10

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain during eye examination of premature infants.

Interventions

Trade Name: Klonidin Product Name: Klonidin Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Solvent for parenteral use Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: Evaluation during the two eye examinations.	—

Measure

Time frame

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.;Timepoint(s) of evaluation of this end point: Evaluation during the two eye examinations.

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Secondary

Measure	Time frame
Secondary end point(s): - GSR: Area small peaks, area huge peaks, peaks per second och average rise time. - Number of reported AEs, SAEs and SUSARS - 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. - AEs, SAEs are collected within 72 hours from the examination. - VAS evaluation after the two eye examinations.	—

Measure

Time frame

Secondary end point(s): - GSR: Area small peaks, area huge peaks, peaks per second och average rise time. - Number of reported AEs, SAEs and SUSARS - 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. - AEs, SAEs are collected within 72 hours from the examination. - VAS evaluation after the two eye examinations.

—

Countries

Sweden

Contacts

Public ContactBarn- och Ungdomskliniken

Region Örebro län

miriam.pettersson@regionorebrolan.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 13, 2026