cloROP: Clonidine as Pain Relief During ROP Eye Examinations

Sponsor

Region Örebro County (Other)

Overall Status

Recruiting

CT.gov ID

NCT04902859

Collaborator

Uppsala County Council, Sweden (Other)

Enrollment

Location

Arms

32.2

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated 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 :

Apr 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Primary Outcome Measures

PIPP-R [Within 30 sec after procedure started]
Pain assessment scale

Secondary Outcome Measures

GSR [Within 30 sec after procedure started]
Galvanic skin response

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Weeks to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)