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Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a
Martina Carlsen Misic1,2, Mats Eriksson2, Erik Normann3,4
1Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Insights
Clonidine may reduce pain and stress in preterm infants during retinopathy of prematurity (ROP) eye exams. This study investigates its analgesic effect in neonatal intensive care units, aiming to improve infant comfort during painful procedures.
Area of Science:
- Neonatal care and pain management
- Ophthalmology and prematurity complications
Background:
- Preterm infants experience significant pain and stress during intensive care, particularly from procedures like retinopathy of prematurity (ROP) screening.
- Current pain management strategies for ROP examinations in preterm infants are insufficient, highlighting the need for effective analgesia.
Purpose of the Study:
- To evaluate the analgesic efficacy of clonidine in preterm infants undergoing ROP eye examinations.
- To assess the impact of clonidine on infant pain and stress responses during this common neonatal procedure.
Main Methods:
- A multicenter, randomized controlled trial with a crossover design involving preterm infants (born before 30 weeks gestation) in Swedish neonatal intensive care units (NICUs).
- Primary outcome: Premature Infant Pain Profile-Revised (PIPP-R) score post-examination.
- Secondary outcomes: Galvanic skin response, adverse events, and physician's assessment of examination ease.
Main Results:
- Data collection and analysis are ongoing.
- Results will be reported on a group level.
Conclusions:
- The study aims to provide evidence for or against the use of clonidine as an effective analgesic for ROP eye examinations in preterm infants.
- Findings will contribute to optimizing pain management protocols in neonatal care.
Introduction:
Preterm infants are at risk of negative consequences from stress and pain at the same time as they often are in need of intensive care that includes painful interventions. One of the frequent painful procedures preterm infants undergo is eye examination screening to detect early signs of ROP (retinopathy of prematurity). These examinations are both stressful and painful, and despite a multitude of research studies, no conclusive pain-relieving treatment has been demonstrated. The main aim of this trial is to investigate the analgesic effect of clonidine during ROP eye examinations.
Methods And Analysis:
The planned study is a multicentre randomised controlled trial with a crossover design. Infants will be recruited from two different neonatal intensive care units (NICUs) in Sweden. Infants born before gestation week 30 (and therefore eligible for ROP screening) and cared for in either of the NICUs will be eligible for inclusion in the study. The primary outcome will be Premature Infant Pain Profile-Revised score within 30 s after starting the examination. Secondary outcomes will be changes in the galvanic skin response parameters (area small peaks, area huge peaks, peaks per second and average rise time) within 30 s after starting the eye examination, together with the number and evaluation of adverse events reported within 72 hours after the examination and the examining physician's assessment of how easy the infant was to examine.
Ethics And Dissemination:
Approval from the Swedish Ethical Review Authority and the Swedish Medical Products Agency has been obtained for the study. Parents of eligible infants will be getting both verbal and written information about the study including that participation is voluntary. Data will be collected and treated in accordance with the European general data protection regulations. The results will be reported on group level and published in a scientific journal.
Trial Registration Number:
ClinicalTrials.gov (NCT04902859).EudraCT (2021-003005-21).
