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

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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.

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Most cited references 29

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The FLACC: a behavioral scale for scoring postoperative pain in young children.

S I Merkel, T Voepel-Lewis, J Shayevitz … (1997)

To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates five categories of pain behaviors: facial expression; leg movement; activity; cry; and consolability. Eighty-nine children aged 2 months to 7 years, (3.0 +/- 2.0 yrs.) who had undergone a variety of surgical procedures, were observed in the Post Anesthesia Care Unit (PACU). The study consisted of: 1) measuring interrater reliability; 2) testing validity by measuring changes in FLACC scores in response to administration of analgesics; and 3) comparing FLACC scores to other pain ratings. The FLACC tool was found to have high interrater reliability. Preliminary evidence of validity was provided by the significant decrease in FLACC scores related to administration of analgesics. Validity was also supported by the correlation with scores assigned by the Objective Pain Scale (OPS) and nurses' global ratings of pain. The FLACC provides a simple framework for quantifying pain behaviors in children who may not be able to verbalize the presence or severity of pain. Our preliminary data indicates the FLACC pain assessment tool is valid and reliable.

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Causes and consequences of inadequate management of acute pain.

Raymond S Sinatra (2010)

Intense acute pain afflicts millions of patients each year. Despite the recently increased focus on the importance of pain control, management of acute pain has remained suboptimal.

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Trends in use of opioids for chronic noncancer pain among individuals with mental health and substance use disorders: the TROUP study.

Jennifer Brennan Braden, Mark Edlund, Thomas D. Sullivan … (2009)

Use of prescription opioids for chronic pain is increasing, as is abuse of these medications, though the nature of the link between these trends is unclear. These increases may be most marked in patients with mental health (MH) and substance use disorders (SUDs). We analyzed trends between 2000 and 2005 in opioid prescribing among individuals with noncancer pain conditions (NCPC), with and without MH and SUDs. Secondary data analysis of longitudinal administrative data from 2 dissimilar populations: a national, commercially insured population and Arkansas Medicaid enrollees. We examined these opioid outcomes: (1) rates of any prescription opioid use in the past year, (2) rates of chronic use of prescription opioids (greater than 90 d in the past year), (3) mean days supply of opioids, (4) mean daily opioid dose in morphine equivalents, and (5) percentage of total opioid dose that was Schedule II opioids. In 2000, among individuals with NCPC, chronic opioid use was more common among those with a MH or SUD than among those without in commercially insured (8% vs. 3%, P<0.001) and Arkansas Medicaid (20% vs. 13%, P<0.001) populations. Between 2000 and 2005, in commercially insured, rates of chronic opioid use increased by 34.9% among individuals with an MH or SUD and 27.8% among individuals without these disorders. In Arkansas Medicaid chronic, opioid use increased by 55.4% among individuals with an MH or SUD and 39.8% among those without. Chronic use of prescription opioids for NCPC is much higher and growing faster in patients with MH and SUDs than in those without these diagnoses. Clinicians should monitor the use of prescription opioids in these vulnerable groups to determine whether opioids are substituting for or interfering with appropriate MH and substance abuse treatment.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2017

Publication date (Electronic): 6 September 2017

Volume: 7

Issue: 9

Electronic Location Identifier: e016225

Affiliations

[1 ] departmentDepartment of Nursing , The University of Melbourne , Melbourne, Australia

[2 ] departmentClinical Sciences , Murdoch Children’s Research Institute (MCRI) , Melbourne, Australia

[3 ] Royal Children’s Hospital , Melbourne, Australia

[4 ] Children's Hospital of Eastern Ontario and University of Ottawa , Ottawa, Canada

[5 ] departmentClinical Epidemiology and Biostatistics Unit , MCRI , Melbourne, Australia

[6 ] departmentDepartment of Paediatrics , The University of Melbourne , Melbourne, Australia

Author notes

[Correspondence to ] Dianne J Crellin; dianne.crellin@ 123456rch.org.au

Article

Publisher ID: bmjopen-2017-016225

DOI: 10.1136/bmjopen-2017-016225

PMC ID: 5589003

PubMed ID: 28882914

SO-VID: 64a0b048-f328-4e97-b673-cf38e27cc265

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 01 February 2017

Date revision received : 24 May 2017

Date accepted : 29 June 2017

Funding

Funded by: Murdoch Childrens Research Institute;

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ScienceOpen disciplines: Medicine

Keywords: protocol,psychometric evaluation,validation,reliability,pain assessment

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ScienceOpen disciplines: Medicine

Keywords: protocol, psychometric evaluation, validation, reliability, pain assessment

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

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Abstract

Introduction

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Methods and analysis

Ethics and dissemination

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RNA drug delivery

Most cited references 29

The FLACC: a behavioral scale for scoring postoperative pain in young children.

Causes and consequences of inadequate management of acute pain.

Trends in use of opioids for chronic noncancer pain among individuals with mental health and substance use disorders: the TROUP study.

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