Clonidine as Pain Relief During ROP Eye Examinations
cloROP
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 4, 2022
April 1, 2022
2.7 years
May 21, 2021
April 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PIPP-R
Pain assessment scale
Within 30 sec after procedure started
Secondary Outcomes (1)
GSR
Within 30 sec after procedure started
Study Arms (4)
Clonidine with eye speculum
EXPERIMENTAL4 mcg/kg Clonidine given orally in GI-tube.
Placebo with eye speculum
PLACEBO COMPARATORSterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
Clonidine without eye speculum
EXPERIMENTAL4 mcg/kg Clonidine given orally in GI-tube.
Placebo without eye speculum
PLACEBO COMPARATORSterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
Interventions
Clonidine prepared from pharmacy with 20 mcg/ml concentration.
Eligibility Criteria
You may qualify if:
- Infants born before 30 weeks gestation, informed consent from parents
You may not qualify if:
- Infants that have received other pain relieving or sedating drugs within 24 hours before the procedure, infants without GI-tube, infants with neurological deficit, infants with known heart arrhythmia, infants with circulatory instability (MAP below GA in weeks)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Örebro Countylead
- Uppsala County Council, Swedencollaborator
Study Sites (1)
Barn- och Ungdomskliniken, Universitetssjukhuset
Örebro, Sweden
Related Publications (1)
Carlsen Misic M, Eriksson M, Normann E, Pettersson M, Blomqvist Y, Olsson E. Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial. BMJ Open. 2022 Sep 22;12(9):e064251. doi: 10.1136/bmjopen-2022-064251.
PMID: 36137627DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- None of the above will be aware of study drug or placebo.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2021
First Posted
May 26, 2021
Study Start
April 25, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 4, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share