Dataset Information

Procedural Pain Scale Evaluation (PROPoSE) study: protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6-42 months.

ABSTRACT:

Introduction

Infants and children are frequently exposed to painful medical procedures such as immunisation, blood sampling and intravenous access. Over 40 scales for pain assessment are available, many designed for neonatal or postoperative pain. What is not well understood is how well these scales perform when used to assess procedural pain in infants and children.

Aim

The aim of this study was to test the psychometric and practical properties of the Face, Legs, Activity, Cry and Consolability (FLACC) scale, the Modified Behavioural Pain Scale (MBPS) and the Visual Analogue Scale (VAS) observer pain scale to quantify procedural pain intensity in infants and children aged from 6-42 months to determine their suitability for clinical and research purposes.

Methods and analysis

A prospective observational non-interventional study conducted at a single centre. The psychometric and practical performance of the FLACC scale, MBPS and the VAS observer pain scale and VAS observer distress scale used to assess children experiencing procedural pain will be assessed. Infants and young children aged 6-42 months undergoing one of four painful and/or distressing procedures were recruited and the procedure digitally video recorded. Clinicians and psychologists will be recruited to independently apply the scales to these video recordings to establish intrarater and inter-rater reliability, convergent validity responsiveness and specificity. Pain score distributions will be presented descriptively; reliability will be assessed using the intraclass correlation coefficient and Bland-Altman plots. Spearman correlations will be used to assess convergence and linear mixed modelling to explore the responsiveness of the scales to pain and their capacity to distinguish between pain and distress.

Ethics and dissemination

Ethical approval was provided by the Royal Children's Hospital Human Research Ethics Committee, approval number 35220B. The findings of this study will be disseminated via peer-reviewed journals and presented at international conferences.

SUBMITTER: Crellin DJ

PROVIDER: S-EPMC5589003 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

Procedural Pain Scale Evaluation (PROPoSE) study: protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6-42 months.

Crellin Dianne J DJ Harrison Denise D Hutchinson Adrian A Schuster Tibor T Santamaria Nick N Babl Franz E FE

BMJ open 20170906 9

<h4>Introduction</h4>Infants and children are frequently exposed to painful medical procedures such as immunisation, blood sampling and intravenous access. Over 40 scales for pain assessment are available, many designed for neonatal or postoperative pain. What is not well understood is how well these scales perform when used to assess procedural pain in infants and children.<h4>Aim</h4>The aim of this study was to test the psychometric and practical properties of the Face, Legs, Activity, Cry an ...[more]

PMID: 28882914

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Project description: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.

Dataset Information

Procedural Pain Scale Evaluation (PROPoSE) study: protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6-42 months.

Introduction

Aim

Methods and analysis

Ethics and dissemination

Publications

Procedural Pain Scale Evaluation (PROPoSE) study: protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6-42 months.

Similar Datasets

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