Keywords
Acute Pain, Analgesia, Child, Emergency Medical Services, Paramedics, Paediatrics
Each year in England, 450,000 children and young people (CYP) under 18 years of age are transported by ambulance to emergency departments. Approximately 20% of these suffer acute pain caused by illness or injury. Pain is a highly complex sensory and emotional experience. The intersection between acute pain, unwell CYP and the unpredictable pre-hospital environment is convoluted. Studies have shown that prehospital pain management in CYP is poor, with 61% of those suffering acute pain not achieving effective pain relief (abolition or reduction of pain score by 2 or more out of 10) when attended by ambulance. Consequences of poor acute pain management include altered pain perception, post-traumatic stress disorder and the development of chronic pain. This realist review will aim to understand how ambulance clinicians can provide improved prehospital acute pain management for CYP.
A realist review will be conducted in accordance with the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidance. A five-stage approach will be adopted; 1) Developing an Initial Programme Theory (IPT): develop an IPT with key stakeholder input and evidence from informal searching; 2) Searching and screening: conduct a thorough search of relevant research databases and other literature sources and perform screening in duplicate; 3) Relevance and rigour assessment: assess documents for relevance and rigour in duplicate; 4) Extracting and organising data: code relevant data into conceptual “buckets” using qualitative data analysis software; and 5) Synthesis and Programme Theory (PT) refinement: utilise a realist logic of analysis to generate context-mechanism-outcome configurations (CMOCs) within and across conceptual “buckets”, test and refine the IPT into a realist PT.
The realist PT will enhance our understanding of what works best to improve acute prehospital pain management in CYP, which will then be tested and refined within a realist evaluation.
PROSPERO Registration: CRD42024505978
Each year in England approximately 90,000 children and young people under 18 years of age suffer with acute pain and require transport by ambulance to emergency departments. The pain may have been caused by injuries such as wounds, burns or broken bones, or by illnesses such as tummy pain. Paramedics and other ambulance clinicians aim to reduce pain at the scene and during hospital transport. Whilst access to pain management is considered a fundamental human right, around 60% of children and young people who require an ambulance do not have their acute pain treated effectively. Without effective pain treatment, adverse consequences such as post-traumatic stress disorder may occur. We aim to understand how ambulance clinicians can provide improved prehospital acute pain management for children and young people.
We will develop a theory about what is most important when considering the improvement of acute pain management for children and young people attended by ambulance. We will use published evidence, opinions from experts in the field, such as paramedics, paramedic educators and clinical leaders, and opinions from members of a Young Persons Advisory Group, to help us create this theory. We will then conduct a thorough search for any published documents that can help us test this theory. Such documents may include published journal articles, clinical practice guidelines, dissertations or newspaper articles for example. We will then use the information within all the relevant documents to test our theory and make refinements. This will allow us to produce a refined theory of what works best to improve acute pain suffered by children and young people who need an ambulance. We will then test and refine this theory in a future study by asking children, young people, parents, carers and ambulance clinicians about parts of the theory.
Acute Pain, Analgesia, Child, Emergency Medical Services, Paramedics, Paediatrics
Minor amendments made in response to peer-review #3. We added references to support the definition of effective pain management, provided a justification for our search restrictions regarding date range and language, added some detail to the section “Step 5: Synthesis and programme theory refinement”, and added some detail to the section “Ambulance clinician involvement.
See the authors' detailed response to the review by Heli Salmi
See the authors' detailed response to the review by Andrit Lourens
See the authors' detailed response to the review by Simit Sapkota and Sunil Shrestha
Ambulance services across England transport 4.7 million patients to emergency departments (ED) each year, of which 450,000 (9.5%) are children and young people (CYP) under 18 years of age1. Acute pain caused by injury or illness is a common symptom presented to ambulance clinicians, and is suffered by approximately 20% of transported CYP2. Paramedics and other ambulance clinicians aim to reduce pain at the scene and during hospital transport3, however this can be challenging in CYP due to a variety of barriers. These include fear and anxiety – which can distort pain assessment4, environmental factors, staff feeling ill prepared to manage pain due to limited education and training and low exposure rates to CYP, and difficulties in assessing and treating pain, particularly regarding limited analgesic options and difficulties of analgesic administration in CYP5.
Access to pain management is considered a fundamental human right6 and effective pain relief has been identified as a key quality outcome measure for ambulance services7. Despite this, prehospital pain management in CYP is considered poor8,9. Ambulances, equipment and staff uniform, are often not tailored towards CYP, and as such, an ambulance call out can be a frightening experience5. A recent study found that only 39% of CYP who suffered acute pain in the prehospital setting achieved effective pain relief (defined as the abolition or reduction of pain >=2 points on a 10-point scale)2,10–12. The consequences of poor acute pain management may include the development of post-traumatic stress disorder13,14, altered pain perception15,16, and the subsequent development of chronic pain17,18.
Typically, within the UK CYP who require an emergency ambulance for acute pain are attended by a registered paramedic or emergency medical technician (EMT). In more critical cases, they may also be attended by paramedics with enhanced skills or doctors via a specialist service. Pain is typically measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale for those unable to communicate their pain, the Wong and Baker FACES® scale for those aged 3 years and above, and the numeric pain rating scale for those aged around 8 years and above3.
The scope of practice between these clinicians vary significantly, with EMTs able to administer only nitrous oxide and simple oral analgesics such as paracetamol and ibuprofen, to paramedics who can also administer paracetamol (intravenous) along with morphine sulfate (oral, subcutaneous, intramuscular, intravenous)19, to paramedics with enhanced skills who can also administer intravenous ketamine. Doctors have a much greater scope of analgesic options available, including fentanyl and diamorphine. The limited range of analgesic options available to UK ambulance clinicians are in part due to legal restrictions19,20 which preclude the use of key controlled drugs such as fentanyl by UK registered paramedics, which can be administered intranasally21 or via a lozenge22. Nitrous oxide is widely available to UK ambulance clinicians but is challenging to administer to CYP due to its cumbersome nature23. Methoxyflurane offers a promising alternative due to its light weight and ease of use, but is not currently licenced for children in the UK24, with results of a major clinical trial due soon25. These legal restrictions may change in the wake of the Manchester Arena Enquiry26 and the recent call to arms to “make children’s pain matter” by Eccleston et al.27, however reliance for improvement should not rest on single strategies. Whilst an increased range of analgesics would be welcome, it would unlikely resolve the complex challenge of providing effective prehospital pain management for CYP28, therefore other strategies should be explored.
This realist review will aim to understand how ambulance clinicians can provide improved prehospital acute pain management for CYP. The review will focus on potential behaviour change intervention components that could be aimed at ambulance clinicians.
A Young Persons Advisory Group (YPAG) has been set up to advise on the initial design of the PANDA Study29. The YPAG group will continue to provide input within this realist review. The group was recruited from a state funded secondary school and comprises 25 members in total. The age range of members spans from 12 to 18 years, 60% are female (n = 15), 64% White (n = 16), 24% Asian or Asian British (n = 6) and 13% Other or Mixed ethnicity (n = 3). Four of the YPAG members have experience of being in an ambulance with a painful condition, three have been in an ambulance for other reasons and four have witnessed friends or family members going into an ambulance. The YPAG group will meet to provide insights and suggestions to develop and refine the initial programme theory (IPT) and to assist in the interpretation of the synthesis and refinement of the realist programme theory.
An established patient and public involvement group based at the University of Lincoln (the Healthier Ageing Patient and Public Involvement (HAPPI) group)), was involved during the initial design of the PANDA Study. The HAPPI group will continue to be involved at key stages throughout this realist review, particularly to assist with the interpretation of findings. The HAPPI Group members will provide input from a “public” perspective and will also bring external expertise to the project from their links to other patient and public involvement groups and from experience of advising several other prehospital ambulance-based research projects.
The overall PANDA Study is a realist informed complex intervention development and feasibility study, consisting of a realist review, a realist evaluation, consensus workshops and a feasibility trial30. The aim of the PANDA Study is to develop and test an intervention to improve pre-hospital pain management for CYP by exploring what interventions work, for whom, in what context and how. This paper reports the protocol for the realist review component of the PANDA Study.
The PANDA Study will be framed within a realist approach as described by Pawson31–33, which aligns to the Medical Research Council guidelines for complex intervention development34. A realist approach seeks to understand why, how, to what extent, for whom and in what circumstances a programme or intervention works35. It assumes that interventions or programmes themselves do not cause outcomes, rather, it is the resources offered by the intervention that trigger a response from the participant through underlying unseen mechanisms, that cause outcomes, within a specific context35. These context-mechanism-outcome configurations (CMOCs) are the foundation on which programme theory is built and may be informed by primary (realist evaluation) or secondary (realist review) data32,33.
A realist review will be conducted, following the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidance35. The realist review has been registered on PROSPERO, the international prospective register of systematic reviews (CRD42024505978)36. There are currently no equator network publication standards for realist review protocols, therefore we used the realist review publication standards as a framework to report this protocol37
The objectives for this realist review are:
1. To develop an IPT to map the key processes of prehospital acute pain management in CYP.
2. To focus on specific areas of the IPT to explore potential behaviour change intervention components aimed at ambulance clinicians and determine; for whom they work; in what circumstances; how; and to what extent they work.
3. To refine the IPT into a realist programme theory supported by context, mechanism, outcome configurations (CMOCs).
We will adopt a five-stage approach to conduct this realist review, informed by the RAMSES guidance35, Pawson32 and a recent realist review38. These steps will include:
The first stage of this realist review will involve locating existing theories about prehospital pain management in CYP. This will involve informal searches to identify key theories in the field, what the predictors, barriers and facilitators are for effective prehospital pain management in CYP, and which components of the process are considered most important. Whilst this process is subjective, we will offset this by involving multiple key stakeholder groups in the development of the IPT, namely an Ambulance Clinician Advisory Group (ACAG), a Young Persons Advisory Group (YPAG) and a PANDA Study Realist Review Working Group. The inclusion of these groups is important as realist reviews are driven by stakeholders, enabling the inclusion of multiple perspectives39,40.
Informal searches will be conducted to ensure that relevant documents are identified, and key data are incorporated within the IPT development process. One member of the review team (GAW) has access to a large number of relevant documents (including journal articles, theses and book chapters), having recently completed a PhD on the topic of prehospital pain management in children. Combining these documents with stakeholder input and iterative discussion within the PANDA Study Realist Review Working Group will enable the development of our IPT.
With the assistance of an academic librarian (MO), the IPT will be used as a framework to develop a comprehensive search strategy.
Database Search: Relevant keywords, subject headings and Boolean operators will be used to search major bibliographic databases. The EBSCOHost platform will be used to search MEDLINE, Cumulative Index to Nursing & Allied Health (CINAHL) Complete, PsycINFO, Web of Science Core Collection, Education Source, Education Resources Information Centre (ERIC), and The Cochrane Library
Searching Other Resources: The clinical trials registry ISRCTN will be searched, along with other literature sources such as ProQuest, including ProQuest Dissertations and Theses, and Google. Expert knowledge will also be used to identify relevant documents not found during these searches. Forward and backward citation tracking will be conducted for all included documents.
Additional searches may be required during the realist review as programme theory testing and refinement progresses. Informed by a recent systematic mixed studies review on this topic that searched core databases from inception, and included papers from 2006 to 20205, we will restrict our search to documents published from January 2000 onwards, due to known limited evidence prior to 20005.
In-line with a realist philosophy of science32, all sources of information may contribute to the development of realist programme theory, therefore we will include, where relevant, research articles, clinical practice guidelines, policy documents, websites of professional bodies or reputable organisations, conference abstracts, theses and dissertations, along with curricula.
In addition to the wide range of documents eligible for inclusion, only documents reported in English (due to time and resource constraints) and involving or aimed at the following populations will be included:
Documents will be excluded if they are:
Based in the battlefield, in-hospital, primary care or helicopter emergency medical service (HEMS) setting. Documents from these settings would not be representative of standard ambulance service practice.
Focussed on chronic pain.
Documents reporting prehospital acute pain management data for children, young people and adults will be excluded if the data for CYP under 18 years of age cannot be isolated and extracted.
Identified documents from the database search will be imported to Covidence (copyright licence obtained) software and screened independently in duplicate. Documents will be screened first by title and abstract, followed by full text review against the inclusion and exclusion criteria. Documents identified from other resources will be added to and managed within MS Excel software and screened independently in duplicate. These documents will be subject to an initial screen, similar in nature to the title and abstract screen, followed by a full-text screen, where the full document will be reviewed against the inclusion and exclusion criteria. Disagreements on inclusion will be resolved through discussion, or involvement of a third member of the review team.
Documents deemed to meet the inclusion criteria will then be assessed for relevance and rigour, as per the RAMESES guidelines35. Relevance relates to the ability of data within a document to contribute to the testing and refinement of programme theory, and rigour relates to whether the methods used to generate the relevant data are credible and trustworthy35. Whilst there is relative consensus regarding the methods to assess the relevance of documents within a realist review, there is substantial uncertainty among academics regarding how best to assess rigour41. Given the adoption of a realist philosophy of science32, using a checklist approach to quality assessment, as standard within a systematic review42, is less helpful in a realist review due to the inclusive nature of data from a wide variety of sources. We will therefore not use critical appraisal/quality checklists as part of our rigour assessment.
The assessment of relevance will be dichotomous (yes/no) and conducted within MS Excel software. Two reviewers will separately assess relevance of a small sample of documents and discuss with the PANDA Study Realist Review Working Group as a benchmarking exercise. If agreement is achieved, the remaining documents will be assessed for relevance, in duplicate. Disagreements will be resolved through discussion, or involvement of a third member of the review team. A third reviewer will assess 10% of reviewed documents to ensure consistency. Documents deemed not relevant will be excluded from the review.
Rigour will be assessed in duplicate by two reviewers independently and based on reviewer judgement of document trustworthiness. A rating scale will be used to determine the rigour of each document (low, moderate or high rigour). Disagreements will be settled through discussion, or the involvement of a third reviewer. A third reviewer will assess 10% of reviewed documents to ensure consistency.
Rigour will be assessed at the level of the data and at the level of the programme theory41. Documents deemed highly trustworthy and credible at the level of the data (for example where clear methods of data production are described and references for evidence sources are listed) and are coherent at the level of the programme theory and provide consilience and analogy (for example where the documents support the programme theory well), will be rated high.
Rigour will not be used as a reason for exclusion43. Instead, CMOCs that are considered conceptually weak (i.e. the documents informing the CMOCs are mostly rated as low or moderate rigour) will be tested further through additional iterative searches, or within the realist evaluation.
The number of included documents will be reported using a PRISMA flow diagram42.
Data extraction will occur in two phases.
1. The characteristics of included documents will be manually extracted into a Microsoft Word document, including bibliographic information and details about document type and population. This will form the summary of included documents table. This will be performed by one reviewer and verified in full by a second.
2. Included documents will then be uploaded to NVivo version 14 (copyright licence obtained) software for data extraction (coding). Data will not be extracted per se, rather the full documents will be uploaded for coding. Qualitative and quantitative text that is relevant to the IPT will be coded; this may consist of descriptions, findings or explanations of programmes or interventions that aim to improve prehospital acute pain management for CYP37.
Coding will be deductive (based on the IPT), inductive (where new conceptual buckets arise) and retroductive (when inferring causal mechanisms within CMOC development). Text will be coded as “parent nodes” or “child nodes” iteratively and combined/expanded during the organising phase of analysis. Coding will be conducted by one reviewer, with 10% of coded documents checked by a second reviewer.
Codes assigned as “parent nodes” will be viewed as conceptual “buckets”44. Text may be coded into more than one conceptual “bucket”.
As more sections of coded text are added to each conceptual “bucket”, two reviewers will periodically pause to determine, as far as possible, what is functioning as context, mechanism and outcome, thereby creating CMOCs. This process will use a realist logic of analysis32. This interpretation will be iterative in nature and reviewed extensively by the Working Group and key stakeholders to reduce researcher bias. Coded text from more than one conceptual “bucket” may be used to create CMOCs. For each developed CMOC, a new “parent node” will be created, with all the supporting data extracts for the CMOC added. This will ensure clean and clear traceability between source data, CMOC and programme theory.
Each developed and substantiated CMOC will contribute to the development and refinement of the realist programme theory. CMOCs that are unsubstantiated, either due to low rigour or conflicting data, may be tested further through additional iterative searches or through the realist evaluation.
Data to inform our interpretation of the relationships between contexts, mechanisms and outcomes will be sought across documents. There may be instances where data coded from documents contradict each other, or only supply part of the CMOC. We may juxtapose, reconcile, adjudicate, consolidate or situate (Pawson, 2006) findings throughout the analytic process, as necessary.
We will test the IPT with data collected and synthesised from this review and refine it into realist programme theory supported by CMOCs. As this review is not assessing a specific intervention or programme, but rather the process of prehospital acute pain management in CYP, we anticipate the realist programme theory to be segregated into stages based on outcome, progressing from proximal outcomes (focussed on ambulance clinicians – such as confidence and knowledge) to more distal outcomes (focussed on CYP – such as pain severity). The programme theory developed from a recent realist review will be used as a framework to develop our realist programme theory45.
The realist programme theory we develop will then be used to develop and test a complex intervention aimed at ambulance clinicians in a future stage of the PANDA Study.
In addition to the patient and public involvement groups, we will involve other key stakeholders including ambulance clinicians, academics, clinical and non-clinical psychologists.
An Ambulance Clinician Advisory Group (ACAG) has been established, with expertise from the fields of clinical practice, education, and senior leadership, ranging from the South to the North of England, and Scotland. The group will meet at several stages of the review to provide insights and their expert knowledge to help with the development and refinement of the IPT, provide advice and feedback on the PT as it develops, identify any relevant literature that will assist with the research and to facilitate the interpretation of the findings.
A bespoke PANDA Study Realist Review Working Group has been created for the realist review component of the PANDA Study, which consists of academics with expertise on realist methods, the prehospital setting and the population of CYP, clinicians, ambulance service representatives, along with clinical and non-clinical psychologists. The group will meet monthly, or more if required, to discuss the progress of the realist review and provide expertise at all stages of the review.
Not required.
NVivo 14 is a proprietary software, free alternatives such as QualCoder (https://qualcoder.wordpress.com/) could be used. Covidence is a proprietary software, alternatives such as Rayyan (https://www.rayyan.ai/) have a free membership option.
Georgie Nicholls: Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing
Georgette Eaton: Methodology, Writing – Review & Editing
Despina Laparidou: Methodology, Writing – Review & Editing
Marishona Ortega: Methodology, Writing – Review & Editing
Kacper Sumera: Methodology, Writing – Review & Editing
Michael Baliousis: Methodology, Writing – Review & Editing
Jessica Hodgson: Methodology, Writing – Review & Editing
Aloysius Niroshan Siriwardena: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing
Paul Leighton: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing
Sarah Redsell: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing
Bill Lord: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing
Tatiana Bujor: Conceptualization, Methodology, Writing – Review & Editing
Gregory Adam Whitley: Conceptualization, Funding Acquisition, Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing
We acknowledge the following individuals and groups for their contribution to the PANDA Study: members of the Young Persons Advisory Group (YPAG), Queen Elizabeth’s High School (QEHS), Gainsborough, for their active participation in the design and delivery of the PANDA Study; Michael Betts (QEHS), Adrian O’Neill (QEHS) and Rick Eastham (QEHS) for setting up the YPAG group and for their ongoing support; members of the Healthier Ageing Patient and Public Involvement (HAPPI) group for their active participation in the design and delivery of the PANDA Study; Martin Esposito (Scottish Ambulance Service), Ashley Scaife (University of Huddersfield), Emily Hoyles (South East Coast Ambulance Service NHS Trust) and Sharon Young (East Midlands Ambulance Service NHS Trust) for their roles as members of the PANDA Study Ambulance Clinician Advisory Group; Tom Waterfield (Queen’s University Belfast), Samina Ali (University of Alberta), Michael Smyth (University of Warwick), Alison Porter (Swansea University) and Amanda Brewster (University of Lincoln HAPPI Group) for their roles as independent members of the PANDA Study steering committee; Gemma Squires (East Midlands Ambulance Service NHS Trust) and Robert Spaight (East Midlands Ambulance Service NHS Trust) for providing governance oversight as sponsor and expert advice.
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: I am a clinical oncologist working in Nepal, with a special interest in pain management and palliative care. I have been trying to formulate a rational use of opioids within the country.
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Published several articles related to acute pain management in the prehospital setting as well as published evidence synthesis articles.
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: I am a clinical oncologist working in Nepal, with a special interest in pain management and palliative care. I have been trying to formulate a rational use of opioids within the country.
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Published several articles related to acute pain management in the prehospital setting as well as published evidence synthesis articles.
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: paediatric critical care
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: paediatric critical care
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Published several articles related to acute pain management in the prehospital setting as well as published evidence synthesis articles.
Alongside their report, reviewers assign a status to the article:
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