Clonidine as Pain Relief During ROP Eye Examinations

NCT ID: NCT04902859

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2024-12-31

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.

Conditions

Retinopathy of Prematurity; Pain, Procedural; Premature Infant Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Clonidine with eye speculum

4 mcg/kg Clonidine given orally in GI-tube.

Group Type: EXPERIMENTAL

Clonidine Oral Liquid Product

Intervention Type: DRUG

Clonidine prepared from pharmacy with 20 mcg/ml concentration.

Placebo with eye speculum

Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: DRUG

Sterile water used as placebo

Clonidine without eye speculum

4 mcg/kg Clonidine given orally in GI-tube.

Group Type: EXPERIMENTAL

Clonidine Oral Liquid Product

Intervention Type: DRUG

Clonidine prepared from pharmacy with 20 mcg/ml concentration.

Placebo without eye speculum

Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: DRUG

Sterile water used as placebo

Interventions

Clonidine Oral Liquid Product

Clonidine prepared from pharmacy with 20 mcg/ml concentration.

Intervention Type: DRUG

Sterile water

Sterile water used as placebo

Intervention Type: DRUG

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)

• Minimum Eligible Age: 5 Weeks
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barn- och Ungdomskliniken, Universitetssjukhuset

Örebro, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Miriam Pettersson, MD, PhD

Role: CONTACT

miriam.pettersson@regionorebrolan.se

+46196023491

Emma Olsson, RN, PhD

Role: CONTACT

emma.olsson@oru.se

+4619303616

Facility Contacts

Miriam Pettersson, PhD

Role: primary

Emma Olsson, PhD

Role: backup

References

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.

Reference Type: DERIVED

PMID: 36137627 (View on PubMed)

Other Identifiers

273547

Identifier Type: -

Identifier Source: org_study_id