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• Pain at the time of vaccine injection is a common concern and contributes to vaccine hesitancy across the lifespan.• Evidence-based and feasible interventions are available to mitigate pain and are part of good vaccination clinical practice.• This guideline includes recommendations for pain mitigation based on five domains of pain management interventions (procedural, physical, pharmacologic, psychological and process): the "5P" approach.

Background:Vaccine injections are the most common painful needle procedure experienced throughout the lifespan. Many strategies are available to mitigate this pain; however, they are uncommonly utilized, leading to unnecessary pain and suffering. Some individuals develop a high level of fear and subsequent needle procedures are associated with significant distress.Objective:The present work is part of an update and expansion of a 2009 knowledge synthesis to include the management of vaccine-related pain across the lifespan and the treatment of individuals with high levels of needle fear. This article will provide a conceptual foundation for understanding: (a) painful procedures and their role in the development and maintenance of high levels of fear; (b) treatment strategies for preventing or reducing the experience of pain and the development of fear; and (c) interventions for mitigating high levels of fear once they are established.Results:First, the general definitions, lifespan development and functionality, needle procedure-related considerations, and assessment of the following constructs are provided: pain, fear, anxiety, phobia, distress, and vasovagal syncope. Second, the importance of unmitigated pain from needle procedures is highlighted from a developmental perspective. Third, the prevalence, course, etiology, and consequences of high levels of needle fear are described. Finally, the management of needle-related pain and fear are outlined to provide an introduction to the series of systematic reviews in this issue.Discussion:Through the body of work in this supplement, the authors aim to provide guidance in how to treat vaccination-related pain and its sequelae, including high levels of needle fear.

Non-pharmacological management of infant and young child procedural pain.

Key points• Vaccine injections performed in childhood are a substantial source of distress.• Untreated pain can have long-term consequences, including preprocedural anxiety, hyperalgesia, needle fears and avoidance of health care.• Simple, cost-effective, evidence-based pain-relieving strategies are available.• A "3-P" approach, combining pharmacologic, physical and psychological factors, improves pain relief.

BackgroundAlthough numerous evidence-based and feasible interventions are available to treat pain from childhood vaccine injections, evidence indicates that children are not benefitting from this knowledge. Unrelieved vaccination pain puts children at risk for significant long-term harms including the development of needle fears and subsequent health care avoidance behaviours. Parents report that while they want to mitigate vaccination pain in their children, they lack knowledge about how to do so. An evidence-based clinical practice guideline for managing vaccination pain was recently developed in order to address this knowledge-to-care gap. Educational tools (pamphlet and video) for parents were included to facilitate knowledge transfer at the point of care. The objectives of this study were to evaluate usability and effectiveness in terms of knowledge acquisition from the pamphlet and video in parents of newly born infants.MethodsMixed methods design. Following heuristic usability evaluation of the pamphlet and video, parents of newborn infants reviewed revised versions of both tools and participated in individual and group interviews and individual knowledge testing. The knowledge test comprised of 10 true/false questions about the effectiveness of various pain management interventions, and was administered at three time points: at baseline, after review of the pamphlet, and after review of the video.ResultsThree overarching themes were identified from the interviews regarding usability of these educational tools: receptivity to learning, accessibility to information, and validity of information. Parents’ performance on the knowledge test improved (p≤0.001) from the baseline phase to after review of the pamphlet, and again from the pamphlet review phase to after review of the video.ConclusionsUsing a robust testing process, we demonstrated usability and conceptual knowledge acquisition from a parent-directed educational pamphlet and video about management of vaccination pain. Future studies are planned to determine the impact of these educational tools when introduced in clinical settings on parent behaviors during infant vaccinations.

Recent research has begun to examine discrete caregiver pain management behaviors in the infant immunization context. However, there is a dearth of research exploring more global caregiving constructs, such as emotional availability, which can be used to examine the overall sensitivity of caregiver pain management. The aim of the present study was to examine the relationships between caregiver sensitivity (emotional availability) and infant pain behavior (baseline, immediately post-needle, 1 min after needle) over the first year of life. Parents and infants were a part of a Canadian longitudinal cohort (the Opportunities to Understand Childhood Hurt or OUCH cohort) followed up during their 2-, 4-, 6-, and 12-month immunizations (current n=731). Both within-age group analyses and over-age analyses were performed. Results indicated that: (1) over age, previous infant pain behavior predicts future infant pain behavior, but this varied depending on timing of pain response and age of infant; (2) over age, previous caregiver sensitivity strongly predicts future caregiver sensitivity; and (3) the concurrent relationship between caregiver sensitivity and every type of infant pain response is only consistently seen at the 12-month immunization. Caregiver sensitivity to the infant in pain is predicted most reliably from previous caregiver sensitivity, not infant pain behaviour. The significant concurrent relationship between caregiver sensitivity and infant pain behaviours is not seen until 12 months, replicating patterns in the infant development literature regarding the time at which the attachment relationship between parent and child can be reliably measured. Discussion addresses implications for both researchers and clinicians who work with infants in pain.

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