PRE-HOSPITAL PAIN MANAGEMENT IN CHILDREN: A MIXED METHODS STUDY Gregory Adam Whitley A thesis submitted in partial fulfilment of the requirements of the University of Lincoln for the degree of Doctor of Philosophy School of Health and Social Care College of Social Science December 2020 Abstract Background Pain is a highly complex sensory and emotional experience; the biological, psychological and social aspects must each be considered. The intersection between the phenomenon of pain, the unpredictable pre-hospital environment and children is highly convoluted. Studies have shown that pre-hospital pain management in children is poor, despite access to pain management being considered a fundamental human right. Without effective pain treatment, children may suffer long-term psychological changes (e.g. altered pain perception) and are at risk of developing post-traumatic stress disorder. The aim of this thesis was to identify predictors, barriers and facilitators associated with effective pre-hospital pain management in children suffering acute pain and to identify ways to improve the quality of care. Methods A postpositivist paradigm was adopted for the study, with a critical realist ontology and a modified objectivist epistemology. A mixed methods sequential explanatory design was adopted, informed by a systematic mixed studies review. The initial quantitative study employed a multivariable logistic regression analysis using routinely collected clinical data to identify predictors of effective pain management. The final qualitative study used face-to-face semi-structured interviews with ambulance clinicians to help explain the identified predictors, identify barriers and facilitators and explore ways to improve the quality of care. Interviews were audio recorded and transcribed verbatim with thematic analysis used to analyse the data. I Results The systematic mixed studies review included 13 studies (8 quantitative and 5 qualitative) and highlighted the importance of analgesic administration. The initial quantitative study included 2312 clinical records; only 39% of children suffering acute pain achieved effective pain management. Predictors of effective pain management included children who were younger, administered analgesics, attended by a paramedic or living in an area of low or medium deprivation. The final qualitative study included 12 ambulance clinicians (9 paramedics and 3 emergency medical technicians) who provided possible explanations for these disparities. Novel barriers and facilitators were also identified along with ways to improve pain management. Meta-inferences were developed which provided a more comprehensive understanding of this complex phenomenon. To improve pre- hospital pain management in children, the following recommendations were made; 1) explore methods to increase rates of analgesic administration, perhaps by utilising the intranasal and inhaled route; 2) reduce fear and anxiety in children, perhaps by using child friendly uniform, non-pharmacological techniques and more public interaction and 3) reduce fear and anxiety in clinicians, by enhancing training, optimising crew mix and developing a more pragmatic pain assessment tool. A theoretical model of pre-hospital pain management in children was developed as part of this thesis. Conclusion Pre-hospital pain management in children may be improved by increasing rates of analgesic administration and reducing the fear and anxiety experienced by children and clinicians. Future research should explore the experience of the child and determine the most important outcome measures. Robust clinical trials are needed to determine the efficacy and safety of intranasal (fentanyl/ketamine) and inhaled (methoxyflurane) analgesics in the pre-hospital setting. Investment in future research and intervention development is imperative; we need to make children’s pain in the pre-hospital setting matter. II Acknowledgements Firstly, to my supervisors Aloysius Niroshan Siriwardena, Pippa Hemingway and Graham Richard Law. I would like to say thank you, sincerely, for your invaluable support and guidance during the last three years. You have been with me from the start, steering me through the dark days and I feel extremely lucky to have been mentored by you all. I am extremely grateful to my funder; the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) for funding this research and particularly Emma Rowley for her assistance and advice. Without the financial support provided by the NIHR ARC-EM, my dream of becoming a clinical academic may not have been realised. I would like to thank Paul Leighton and the East Midlands Research Design Service for providing support during the funding application stage of this research. To the East Midlands Ambulance Service NHS Trust, in particular Anne Spaight, Robert Spaight and Debbie Shaw for their support and advice given during the development and undertaking of this PhD, Paul Litherland for supporting my transition to part-time clinical hours in order for me to pursue a clinical academic career and to the clinicians who participated in the qualitative study, thank you. I would like to give special thanks to Caitlin Wilson, a paramedic researcher who willingly took time out of her own PhD to assist with the analysis of my data. Thank you. For the extensive help I received while performing my systematic mixed studies review, I would like to thank Ffion Curtis, Arwel Jones, Jolein Vos, Benjamin Roadley, Anna Bichmann and Marishona Ortega. I received mentorship and training within the Community and Health Research Unit (CaHRU) at the University of Lincoln, therefore I would like to thank all members of CaHRU for providing training, advice and guidance over the years. Most importantly, I would like to thank my wife Laura and children James (aged 7) and Thomas (aged 3) for supporting and enduring my studies throughout school holidays and weekends for the last three years, especially during the coronavirus lockdown in 2020. I will be forever indebted to my family for their support. III Funding statement This research was funded by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM). The views expressed in this thesis are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. Thesis Word Count: 72,500 (excluding tables, references and appendices). IV Contents List of tables ..................................................................................................... VIII List of figures ...................................................................................................... IX List of appendices ................................................................................................ X List of abbreviations ........................................................................................... XI List of publications associated with this thesis ................................................... XII List of presentations from this thesis................................................................. XIV List of training undertaken ................................................................................. XV Chapter 1 – Introduction ...................................................................................... 1 1.1 Personal statement ............................................................................................ 1 1.2 Context ............................................................................................................... 3 1.2.1 Ambulance service ...................................................................................... 3 1.2.2 Pain .............................................................................................................. 5 1.2.3 Children ..................................................................................................... 12 1.2.4 Pre-hospital pain management in children ............................................... 17 1.2.5 Wider context............................................................................................ 23 1.3 Research Question ........................................................................................... 27 1.4 Research Aim and Objectives ........................................................................... 30 1.4.1 Aim ............................................................................................................ 30 1.4.2 Objectives .................................................................................................. 30 1.5 Overview of Thesis ........................................................................................... 31 Chapter 2 – Philosophy and Methodology .......................................................... 32 2.1 Philosophy ........................................................................................................ 32 2.1.1 A brief history of philosophy ..................................................................... 32 2.1.2 Philosophical paradigm ............................................................................. 34 2.1.3 Postpositivism ........................................................................................... 36 2.1.4 Other paradigms ....................................................................................... 38 2.1.5 Philosophy in mixed methods research ...................................................