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Clonidine as Pain Relief During ROP Eye Examinations (cloROP)

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ClinicalTrials.gov Identifier: NCT04902859
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : May 4, 2022
Sponsor:
Collaborator:
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Region Örebro County

Study Description
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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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Pain, Procedural Premature Infant Disease Drug: Clonidine Oral Liquid Product Drug: Sterile water Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: None of the above will be aware of study drug or placebo.
Primary Purpose: Treatment
Official Title: Clonidine as Pain Relief During ROP Eye Examinations
Actual Study Start Date : April 25, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Clonidine with eye speculum
4 mcg/kg Clonidine given orally in GI-tube.
 Drug: Clonidine Oral Liquid Product
Clonidine prepared from pharmacy with 20 mcg/ml concentration.
Placebo Comparator: Placebo with eye speculum
Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
 Drug: Sterile water
Sterile water used as placebo
Experimental: Clonidine without eye speculum
4 mcg/kg Clonidine given orally in GI-tube.
 Drug: Clonidine Oral Liquid Product
Clonidine prepared from pharmacy with 20 mcg/ml concentration.
Placebo Comparator: Placebo without eye speculum
Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
 Drug: Sterile water
Sterile water used as placebo


Outcome Measures
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Primary Outcome Measures :
  1. PIPP-R [ Time Frame: Within 30 sec after procedure started ]
    Pain assessment scale


Secondary Outcome Measures :
  1. GSR [ Time Frame: Within 30 sec after procedure started ]
    Galvanic skin response


Eligibility Criteria
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Ages Eligible for Study:   5 Weeks to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04902859


Contacts
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Contact: Miriam Pettersson, MD, PhD +46196023491 miriam.pettersson@regionorebrolan.se
Contact: Emma Olsson, RN, PhD +4619303616 emma.olsson@oru.se

Locations
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Sweden
Barn- och Ungdomskliniken, Universitetssjukhuset Recruiting
Örebro, Sweden
Contact: Miriam Pettersson, PhD         
Contact: Emma Olsson, PhD         
Sponsors and Collaborators
Region Örebro County
Uppsala County Council, Sweden
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Region Örebro County
ClinicalTrials.gov Identifier: NCT04902859    
Other Study ID Numbers: 273547
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Örebro County:
retinopathy of prematurity
procedural pain
neonatal
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Infant, Premature, Diseases
Pain, Procedural
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Clonidine
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action