Evidence map›Paper›PMID 36137627›Full record

ArticleBMJ open2022

Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial.

Martina Carlsen Misic, Mats Eriksson, Erik Normann, Miriam Pettersson, Ylva Blomqvist, Emma Olsson

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04902859 (Clonidine as Pain Relief During ROP Eye Examinations), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04902859 phase4unknown statusnot on this map

Clonidine as Pain Relief During ROP Eye Examinations

TypeinterventionalSponsorRegion Örebro CountyRan2022 to 2024Enrolled50ConditionsRetinopathy of Prematurity, Pain, Procedural, Premature Infant DiseaseArmsClonidine Oral Liquid Product, Sterile water
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Martina Carlsen MisicDepartment of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Mats ErikssonFaculty of Medicine and Health, School of Health Sciences, Örebro University, Örebro, Sweden.ORCID 0000-0002-5996-2584
Erik NormannUniversity Hospital, Neonatal Intensive Care Unit, Uppsala, Sweden.
Miriam PetterssonDepartment of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Ylva BlomqvistUniversity Hospital, Neonatal Intensive Care Unit, Uppsala, Sweden.ORCID 0000-0001-5955-1278
Emma OlssonDepartment of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden emma.olsson@oru.se.ORCID 0000-0002-5582-6147
Örebro University · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPreterm 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).

Indexed as

AnalgesiaInfant, Premature, DiseasesRetinopathy of PrematurityAnalgesicsClonidineHumansInfantInfant, NewbornInfant, PrematureMulticenter Studies as TopicPainRandomized Controlled Trials as TopicAnalgesicsClonidineneonatal intensive & critical carepaediatric ophthalmologypain management

Identifiers

PMID36137627
PMCPMC9511565
OpenAlexW4296795084

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.