Evidence map›Paper›PMID 30509743›Full record

Trial reportLancet (London, England)2018

Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

Caroline Hartley, Fiona Moultrie, Amy Hoskin, Gabrielle Green, Vaneesha Monk, Jennifer L Bell, Andrew R King, Miranda Buckle, Marianne van der Vaart, Deniz Gursul and 7 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06067958 (Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity), which is not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
20.7field-weighted citation impact, top 1% 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.

NCT06067958 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial

TypeinterventionalSponsorAssaf-Harofeh Medical CenterRan2023 to 2025Enrolled30ConditionsRetinopathy of Prematurity, DexmedetomidineArmsDexmedetomidine, Saline
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Pooled it
  2. Analgesia for retinopathy of prematurity screening: A systematic review.Pain practice : the official journal of World Institute of Pain · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Caroline HartleyDepartment of Paediatrics, University of Oxford, Oxford, UK.
Fiona MoultrieDepartment of Paediatrics, University of Oxford, Oxford, UK.
Amy HoskinDepartment of Paediatrics, University of Oxford, Oxford, UK.
Gabrielle GreenDepartment of Paediatrics, University of Oxford, Oxford, UK.
Vaneesha MonkDepartment of Paediatrics, University of Oxford, Oxford, UK.
Jennifer L BellNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Andrew R KingNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Miranda BuckleDepartment of Paediatrics, University of Oxford, Oxford, UK.
Marianne van der VaartDepartment of Paediatrics, University of Oxford, Oxford, UK.
Deniz GursulDepartment of Paediatrics, University of Oxford, Oxford, UK.
Sezgi GoksanDepartment of Paediatrics, University of Oxford, Oxford, UK.
Edmund JuszczakNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Jane E NormanTommy's Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Richard RogersDepartment of Anaesthetics, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Chetan PatelDepartment of Ophthalmology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Eleri AdamsNewborn Care Unit, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Rebeccah SlaterDepartment of Paediatrics, University of Oxford, Oxford, UK. Electronic address: rebeccah.slater@paediatrics.ox.ac.uk.
University of Oxford · GBJohn Radcliffe Hospital · GBQueen's Medical Centre · GB

Funding

Medical Research Council MC_PC_15110Medical Research Council MR/J000256/1Medical Research Council MR/P006965/1Wellcome TrustWellcome Trust WT095802MA
6 · The paper itself

Abstract

backgroundInfant pain has immediate and long-term effects but is undertreated because of a paucity of evidence-based analgesics. Although morphine is often used to sedate ventilated infants, its analgesic efficacy is unclear. We aimed to establish whether oral morphine could provide effective and safe analgesia in non-ventilated premature infants for acute procedural pain.

methodsIn this single-centre masked trial, 31 infants at the John Radcliffe Hospital, Oxford, UK, were randomly allocated using a web-based facility with a minimisation algorithm to either 100 μg/kg oral morphine sulphate or placebo 1 h before a clinically required heel lance and retinopathy of prematurity screening examination, on the same occasion. Eligible infants were born prematurely at less than 32 weeks' gestation or with a birthweight lower than 1501 g and had a gestational age of 34-42 weeks at the time of the study. The co-primary outcome measures were the Premature Infant Pain Profile-Revised (PIPP-R) score after retinopathy of prematurity screening and the magnitude of noxious-evoked brain activity after heel lancing. Secondary outcome measures assessed physiological stability and safety. This trial is registered with the European Clinical Trials Database (number 2014-003237-25).

findingsBetween Oct 30, 2016, and Nov 17, 2017, 15 infants were randomly allocated to morphine and 16 to placebo; one infant assigned placebo was withdrawn from the study before monitoring began. The predefined stopping boundary was crossed, and trial recruitment stopped because of profound respiratory adverse effects of morphine without suggestion of analgesic efficacy. None of the co-primary outcome measures differed significantly between groups. PIPP-R score after retinopathy of prematurity screening was mean 11·1 (SD 3·2) with morphine and 10·5 (3·4) with placebo (mean difference 0·5, 95% CI -2·0 to 3·0; p=0·66). Noxious-evoked brain activity after heel lancing was median 0·99 (IQR 0·40-1·56) with morphine and 0·75 (0·33-1·22) with placebo (median difference 0·25, 95% CI -0·16 to 0·80; p=0·25).

interpretationAdministration of oral morphine (100 μg/kg) to non-ventilated premature infants has the potential for harm without analgesic efficacy. We do not recommend oral morphine for retinopathy of prematurity screening and strongly advise caution if considering its use for other acute painful procedures in non-ventilated premature infants.

fundingWellcome Trust and National Institute for Health Research.

Indexed as

Administration, OralAnalgesics, OpioidBradycardiaFemaleGestational AgeHumansInfant, Extremely Low Birth WeightInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMaleMorphineOxygen ConsumptionPain MeasurementProcedural PainSingle-Blind MethodAnalgesics, OpioidMorphine

Identifiers

PMID30509743
PMCPMC6294828
OpenAlexW2902137012

What OpenQuestion holds

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LicenceCC BY
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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.