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Clonidine as Pain Relief During ROP Eye Examinations

NCT04902859 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-04

No results posted yet for this study

Summary

Preterm infants are at risk of developing ROP (retinopathy of prematurity), an eye condition that can cause blindness. Preterm infants born before gestation week (GA) 30 are therefor screened regularly with eye examinations. These eye examinations are painful and despite a lot of research no clear method of pain relief have been found. Since pain in the preterm infant can lead to both short- and longterm negative consequences an effective pain relief during these examinations are of importance. In this study we will investigate if Clonidine can be effective as pain-relief during ROP eye examinations.

Conditions

  • Retinopathy of Prematurity
  • Pain, Procedural
  • Premature Infant Disease

Interventions

DRUG

Clonidine Oral Liquid Product

Clonidine prepared from pharmacy with 20 mcg/ml concentration.

DRUG

Sterile water

Sterile water used as placebo

Sponsors & Collaborators

  • Uppsala County Council, Sweden

    collaborator OTHER_GOV

  • Region Örebro County

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Weeks
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902859 on ClinicalTrials.gov