Clonidine as Pain Relief During ROP Eye Examinations (cloROP)
Primary Purpose
Retinopathy of Prematurity, Pain, Procedural, Premature Infant Disease
Status
Recruiting
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Clonidine Oral Liquid Product
Sterile water
Sponsored by
About this trial
This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring retinopathy of prematurity, procedural pain, neonatal
Eligibility Criteria
Inclusion Criteria:
- Infants born before 30 weeks gestation, informed consent from parents
Exclusion Criteria:
- 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)
Sites / Locations
- Barn- och Ungdomskliniken, UniversitetssjukhusetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Clonidine with eye speculum
Placebo with eye speculum
Clonidine without eye speculum
Placebo without eye speculum
Arm Description
4 mcg/kg Clonidine given orally in GI-tube.
Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
4 mcg/kg Clonidine given orally in GI-tube.
Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
Outcomes
Primary Outcome Measures
PIPP-R
Pain assessment scale
Secondary Outcome Measures
GSR
Galvanic skin response
Full Information
NCT ID
NCT04902859
First Posted
May 21, 2021
Last Updated
April 28, 2022
Sponsor
Region Örebro County
Collaborators
Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04902859
Brief Title
Clonidine as Pain Relief During ROP Eye Examinations
Acronym
cloROP
Official Title
Clonidine as Pain Relief During ROP Eye Examinations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
Uppsala County Council, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Infants born before gestational week (GA) 30 who are cared for in neonatal units at the university hospitals in Örebro and Uppsala, Sweden can be included in the study.
According to power calculations 18 infants are needed for a power of 80% and significance level of 0.05 in order to cover for potential dropouts we plan to include 25 infants. Since the eye examinations are performed without eye speculum in Örebro and with eye speculum in Uppsala we plan to include 25 infants at each unit. The patient will be its own control and examined according to the units´ guidelines. Data will be collected during the patients´ first two eye examinations. In order to exclude potential effects of previous pain experience the order of treatment (clonidine/sterile water) will be randomized.
Sixty minutes before the first eye examination the infant will receive Clonidine or sterile water in corresponding volumes in the GI-tube by a nurse. During the examination the infant will be placed on a heated examination table and connected to an oxygen saturation probe (measuring oxygen saturation and heart rate) on one foot and electrodes for Galvanic skin response (GSR) on the other. The ophthalmologist will examine the infants eyes without eye speculum or with eye speculum on the respective unit. The infants face, oxygen saturation and heart rate will be videotaped before, during and after the examination making it possible to perform av PIPP-R pain assessment at a later time.
After the eye examination the ophtalmologist will be asked to estimate hos easy the infant was to examine by putting an "x" somewhere on a 10 centimeter long line where one end signifies "very easy to examine" and the other end signifies "very difficult to examine". The ophtalmologist can also write any other comments regarding the examination on the same form. The same procedure will be repeated during the infants´ second examination, but with the treatment he/she did not receive during the first examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity, Pain, Procedural, Premature Infant Disease
Keywords
retinopathy of prematurity, procedural pain, neonatal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
None of the above will be aware of study drug or placebo.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clonidine with eye speculum
Arm Type
Experimental
Arm Description
4 mcg/kg Clonidine given orally in GI-tube.
Arm Title
Placebo with eye speculum
Arm Type
Placebo Comparator
Arm Description
Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
Arm Title
Clonidine without eye speculum
Arm Type
Experimental
Arm Description
4 mcg/kg Clonidine given orally in GI-tube.
Arm Title
Placebo without eye speculum
Arm Type
Placebo Comparator
Arm Description
Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
Intervention Type
Drug
Intervention Name(s)
Clonidine Oral Liquid Product
Intervention Description
Clonidine prepared from pharmacy with 20 mcg/ml concentration.
Intervention Type
Drug
Intervention Name(s)
Sterile water
Intervention Description
Sterile water used as placebo
Primary Outcome Measure Information:
Title
PIPP-R
Description
Pain assessment scale
Time Frame
Within 30 sec after procedure started
Secondary Outcome Measure Information:
Title
GSR
Description
Galvanic skin response
Time Frame
Within 30 sec after procedure started
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants born before 30 weeks gestation, informed consent from parents
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Pettersson, MD, PhD
Phone
+46196023491
Email
miriam.pettersson@regionorebrolan.se
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Olsson, RN, PhD
Phone
+4619303616
Email
emma.olsson@oru.se
Facility Information:
Facility Name
Barn- och Ungdomskliniken, Universitetssjukhuset
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Pettersson, PhD
First Name & Middle Initial & Last Name & Degree
Emma Olsson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36137627
Citation
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.
Results Reference
derived
Learn more about this trial
Clonidine as Pain Relief During ROP Eye Examinations
We'll reach out to this number within 24 hrs