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Introduction: Community pharmacists report that providing vaccinations can be challenging, particularly if the vaccine recipient is a child, because of heightened levels of fear. The objective of this study was to determine acceptability and feasibility of the CARD (Comfort Ask Relax Distract) system as a vaccination delivery framework for children receiving COVID-19 vaccinations in a community pharmacy setting. CARD incorporates evidence-based interventions that reduce fear and immunization stress-related responses in vaccine recipients and was demonstrated to be effective and feasible in other vaccination settings providing vaccinations to children and adults. Methods: This mixed-methods study involved 5 independent pharmacies (with 6 vaccinators) offering COVID-19 vaccinations to children between 5 and 11 years of age. Vaccinating staff and implementation leads from the pharmacy organization participated in a small-scale CARD implementation project (before-and-after design). Afterwards, they filled in quantitative surveys and provided qualitative feedback about their perceptions and experiences in focus group discussions. Qualitative data were analyzed deductively, using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted between January 16 and March 20, 2022. Across both quantitative and qualitative measures, vaccinating staff reported positive attitudes about CARD and alignment with their professional roles. They reported that CARD reduced children’s fear and improved the vaccination experiences in children and parents and for themselves. Vaccinators reported increased confidence due to CARD. They reported compatibility of CARD interventions within their practice and that it was time neutral. They maintained use of some interventions after the study. They also provided suggestions and shared concerns about fidelity and future feasibility of continuing various components of the program. Conclusion: CARD was demonstrated to be acceptable and feasible by vaccinators performing vaccinations in children in community pharmacies.

This study examined perceptions of children and parents about a new web-based CARD (Comfort, Ask, Relax, Distract) game that teaches children how to cope with needle-related pain and fear. A convenience sample of 15 child-parent dyads (children, 6-12 years) participated. Children played the game on a handheld device while being virtually monitored. Activity tracking revealed most children engaged with multiple components. Children reported they understood the game, it was easy to play, they learned coping strategies and believed they could implement them. Children reported lower fear of needles after playing. Parents liked the simplicity and variety of game activities. Most children and parents reported they would use the game or its coping strategies for future needles and would recommend the game. In summary, children and parents found the CARD web game acceptable and appropriate. Future studies can evaluate its effectiveness when integrated into upcoming needle procedures like COVID-19 vaccinations.

Introduction: We explored Canadian community pharmacists’ perceptions of the CARD (Comfort Ask Relax Distract) system, a vaccine delivery framework that integrates evidence-based interventions that reduce immunization stress-related responses (ISRRs). The objective was to introduce CARD to pharmacists and obtain their feedback to guide future implementation efforts for community pharmacy-based vaccinations. Methods: Eighteen pharmacists across all provinces participated in one-on-one moderated virtual interviews. A semistructured interview guide was used to guide the discussion and included questions about experiences with coronavirus disease 2019 (COVID-19) vaccine administration and perceptions of CARD as a framework for vaccination delivery in the pharmacy. In this report, we focus on feedback about CARD. Interviews were audio-recorded and transcribed verbatim and deductively coded using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted from May 28 to August 16, 2021. Pharmacists’ responses were categorized in 3 CFIR domains: intervention characteristics, inner setting and characteristics of individuals. Overall, pharmacists were receptive towards CARD and thought it filled a current gap in practice, particularly for childhood vaccinations. Pharmacists reported learning techniques to make vaccinations more comfortable for their clients. They provided feedback on how specific interventions could be adapted for their practice (e.g., dissemination of client-directed education via appointment booking portals, provision of distraction items in waiting and vaccinating spaces). Discussion: This study provided preliminary evidence that pharmacists found CARD acceptable and appropriate for community pharmacy-based vaccinations. The data collected from this study were used to inform a small-scale implementation project with CARD during COVID-19 vaccine administration in children aged 5 to 11 years.

Injection-related pain and fear are common adverse reactions in children undergoing vaccination and influence vaccine acceptance. Despite the large body of literature on sources of vaccine non-compliance, there is no estimate of the prevalence of pain and fear as contributing factors. The objective was to estimate the prevalence of injection pain or fear of needles as barriers to childhood (i.e., 0-18 years) vaccination.Four databases were searched from inception for relevant English and French articles until August 2021. In addition, the references of recent systematic reviews and all articles included in the review were hand searched. Article screening and data extractions were performed in duplicate. Studies were included if they reported on injection-related pain or fear of needles in children (0-18 years) using a checklist/closed-ended question(s). Results were stratified by respondent (parents or children), type of pediatric population (general or under-vaccinated), and relative importance of barrier (pain or needle fear as primary reason or any reason for under-vaccination). Prevalence rates of pain or needle fear were combined using a random effects model. Quality of included studies was assessed using the Joanna Briggs Institute critical appraisal checklist for prevalence data. Quality across studies was assessed using GRADE.There were 26 studies with 45 prevalence estimates published between 1995 and 2021. For parent reports (of children) and children self-reported reasons for non-compliance, prevalence rates of pain or needle fear ranged from 5 to 13% in a general population and 8 to 28% in an under-vaccinated population, with a substantial variation in the prevalence estimates. There was no difference between category of respondent or relative importance on pain or needle fear prevalence rate. A regression model demonstrated an overall prevalence rate of pain or needle fear as an obstacle to vaccination of 8% in the general population and 18.3% in the under-vaccinated population. All evidence was very low in quality.This is the first review to systematically quantify the prevalence and therefore, importance, of pain and needle fear as obstacles to vaccination in children around the world. Pain from injection or fear of needles were demonstrated to be sufficiently prevalent as barriers to vaccination in children to warrant attention. Addressing pain and fear has the potential to significantly improve vaccination acceptance.

Introduction: CARD (Comfort Ask Relax Distract) is a vaccine delivery program demonstrated to reduce pain, fear and associated immunization stress-related responses (ISRR) in children undergoing vaccinations at school. This study evaluated CARD’s clinical impact when integrated into community pharmacy–based pediatric vaccinations. Methods: This was a before-and-after CARD implementation study in 5 independent pharmacies offering COVID-19 vaccinations to children aged 5-11 years. No changes were made to practices in the “before” phase. CARD interventions were integrated in the “after” phase (e.g., children prepared a coping plan using a checklist, distraction toolkits were placed in waiting and vaccination spaces, vaccinations were performed with privacy, needles were obscured). Children self-reported ISRR, including fear, pain and dizziness during vaccination, and both children and parents/caregivers (herein, parents) compared the child’s experience to their last needle (better, same, worse). In the “after” phase, parents and children reported how much CARD helped (not at all, a little bit, a moderate amount, a lot). Results: The study was conducted between January 16 and March 20, 2022. Altogether, 152 children participated (71 before and 81 after CARD); demographic characteristics did not differ. Children’s self-reported fear was lower after CARD, when assessed continuously (2.5 vs 3.7 out of 10; p = 0.02) or dichotomously, using a cut-off of 0 vs >0 (58% vs 80%; p = 0.01). Pain was lower when assessed dichotomously (Conclusion: CARD reduced children’s fear and improved vaccination experiences for children and parents when integrated in community pharmacy–based vaccinations.

Background: Throughout the COVID-19 pandemic, community pharmacists have played an important role in the provision of patient care, including the delivery of COVID-19 vaccines. The additional workload and related demands arising from these extended services might affect worklife burnout. This qualitative study explored the experiences of Canadian community pharmacists in providing COVID-19 vaccines during the COVID-19 pandemic. Methods: Eighteen community pharmacists across 10 provinces were asked about vaccination processes and perceptions about their role in separate, virtual semistructured interviews. Interviews were transcribed verbatim and analyzed using a deductive approach using the Areas of Worklife Burnout framework, with pharmacists’ self-reported descriptions of their activities summarized using the Association of Faculties of Pharmacy of Canada’s (AFPC) professional competencies framework. Results: Participants identified aspects of their role that were rewarding and challenging. Some challenges included lack of control, increased workload, inadequate communication, unfair treatment and conflicting values. They described being able to meet challenges and demonstrating resiliency via adaptability, developing communities and valuing their contribution to ending the COVID-19 pandemic. Self-identified AFPC competencies contributing to their ability to manage their worklife included care-provider, professional, leader-manager, collaborator and scholar. Conclusion: Pharmacists accepted their additional responsibility of managing COVID-19 vaccines during the COVID-19 pandemic. However, they expressed some challenges with this role. To ensure sustainability of these services, prioritizing adequate resources, work processes and efficient communication with all relevant stakeholder groups, including public health, government and corporate leaders, is recommended for the future. Can Pharm J (Ott) 2023;156(Suppl):xx-xx.

Existing research has identified evidence-based strategies for mitigating fear and pain during needle procedures; yet, families often experience limited access to health professionals who deliver these interventions. Children may benefit from learning about such strategies in a developmentally appropriate and accessible format such as a picture book. This review aimed to summarize content related to needle procedures represented in picture books for 5- to 8-year-old children. Key terms were searched on Amazon, and the website was used to screen for relevant eligibility criteria. Three levels of screening and exclusions resulted in a final sample of 48 books. Quantitative content analysis was used to apply a coding scheme developed based on relevant Clinical Practice Guidelines and systematic reviews. Cohen’s Kappa indicated strong reliability, and frequencies were calculated to summarize the content. The books were published between 1981 and 2022. All 48 books included at least one evidence-based coping strategy. Distressing aspects such as scary visuals were often included (27.1%), as well as specific expressions of fear (52.1%) and pain (16.7%). Overall, this study paves the way for researchers interested in evaluating the effectiveness of picture books on children’s knowledge and self-efficacy, as well as creating interventions for coping.

Problem Children undergoing medical procedures can experience pain and distress. While numerous interventions exist to mitigate pain and distress, the ability to individualize the intervention to suit the needs and preferences of individual children is emerging as an important aspect of providing family-centered care and shared decision making. To date, the approaches for supporting children to express their preferences have not been systematically identified and described. A scoping review was conducted to identify such approaches and to describe the elements that are included in them. Eligibility criteria Studies that (a) described approaches with the aim to support children to express their coping preferences during medical procedures; (b) included the option for children to choose coping interventions; (c) included a child (1‐–18 years). Sample Searches were conducted in December 2019 and November 2020 in the following databases: Cinahl, Embase, PubMed and Psycinfo. Results Thirteen studies were identified that included six distinct approaches. Four important key elements were identified: 1) Aid to express preferences or choice, 2) Information Provision, 3) Assessment of feelings/emotions, 4) Feedback/Reflection and Reward. Conclusions Identified approaches incorporate components of shared decision-making to support children in expressing their preferences during medical procedures and treatments. Implications Children undergoing medical procedures can be supported in expressing their coping needs and preferences by using components of shared decision-making.

Introduction: The scope of practice for pharmacy technicians is expanding to include vaccine administration in some provinces. Vaccine training courses and programs currently do not include education about mitigating immunization stress-related responses (ISRR) and improving the vaccination experience. We obtained feedback from pharmacy technician students about a new e-module that addresses this identified knowledge gap, whereby learners are educated about CARD (Comfort Ask Relax Distract), a vaccine delivery framework that reduces ISRR and improves the vaccination experience. Methods: Mixed-methods design including second-year pharmacy technician students who elected to take an accredited vaccine injection training program. Students were given access to the CARD e-module after completing mandatory vaccine education components. Eight students answered a quantitative survey and 4 (50%) additionally participated in a focus group. Qualitative data were analyzed deductively using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted between April 28 and June 12, 2022. Students reported positive attitudes about the CARD e-module across quantitative and qualitative measures. Qualitative feedback spanned 4 CFIR constructs: intervention characteristics, outer setting, inner setting and individual characteristics. Students reported the e-module was well designed and that the content was relevant. They believed CARD facilitated provision of vaccinations using a person-centred approach that promotes vaccination. They felt that CARD could potentially add time to the vaccination appointment and that it would need to be acceptable to pharmacy leaders because of implications for training and vaccination delivery. They suggested that CARD education should be mandatory. CARD improved their confidence in delivering vaccinations, and they planned to integrate CARD into their practice. Conclusion: The CARD e-module was well received by pharmacy technician students when coupled with usual vaccine injection training.

ObjectiveAcetaminophen is the most common medication prescribed in children’s hospitals. The aim of the study was to estimate the frequency and risk factors for acetaminophen underdosing and overdosing in the paediatric intensive care unit (PICU).DesignRetrospective cohort of drug administrations in a large tertiary care PICU.PatientsAll PICU admissions, less than 18 years of age, admitted between 1 January 2008 and 1 January 2018, having received at least one dose of enteral acetaminophen.MethodsThe primary outcome was acetaminophen underdosing and overdosing, defined as doses exceeding the 10% upper and lower limits of the standard reference range (10–15 mg/kg) and 10% above daily maximum dose (75 mg/kg). A generalised estimating equation regression assessed patient risk factors for single underdosing, single overdosing and cumulative daily overdosing of acetaminophen.ResultsOf the 147 485 doses of enteral acetaminophen administered, 7814 (5.3%) were single underdoses (1 in every 19 doses) and 4640 (3.1%) were single overdoses (1 in every 32 doses). There were 6813 cumulative overdose days (1 in every 9 patient-days). Risk factors for both underdosing and overdosing included older age and cardiac admission, whereas risk factors for cumulative overdosing were young age and cardiac admission. Electronic prescribing increased the risk of underdosing and overdosing, but decreased cumulative acetaminophen overdosing (relative risk 0.51, p=0.001).ConclusionAcetaminophen underdosing and overdosing are common in the PICU and can be detected with pharmacoepidemiology. Electronic prescribing increased the risk of single underdosing and overdosing, although it reduced the risk of cumulative overdosing.

Background Vaccination is a common painful procedure for children. Parents’ concern regarding vaccination pain is a significant driver of vaccine hesitancy. Despite the wealth of evidence-based practices available for managing vaccination pain, parents lack knowledge of, and access to, these strategies. Knowledge translation (KT) tools can communicate evidence-based information to parents, however little is known about what factors influence parents’ use of these tools. A two-page, electronic KT tool on psychological, physical, and pharmacological vaccination pain management strategies for children, was shared with parents as part of a larger mixed methods study, using explanatory sequential design, exploring factors related to uptake of this KT tool. The aim of this qualitative study was to understand what influenced parents’ perceptions of the relevance of the KT tool, as well as their decision as to whether to use the tool. Methods A qualitative descriptive design was used. A total of 20 parents of children aged 0–17 years (n = 19 mothers) reviewed the KT tool ahead of their child’s upcoming vaccination and participated in a semi-structured interview at follow-up. Interviews were recorded, transcribed verbatim, and analyzed with reflexive thematic analysis using an inductive approach. Results The analysis generated three interrelated themes which described factors related to parents’ use of the KT tool: (1) Relevance to parents’ needs and circumstances surrounding their child’s vaccination; (2) Alignment with parents’ personal values around, and experiences with, vaccination pain management (e.g., the importance of managing pain); and (3) Support from the clinical environment for implementing evidence-based strategies (e.g., physical clinical environment and quality of interactions with the health care provider). Conclusions Several factors were identified as central to parents’ use of the KT tool, including the information itself and the clinical environment. When the tool was perceived as relevant, aligned with parents’ values, and was supported by health care providers, parents were more inclined to use the KT tool to manage their children’s vaccination pain. Future research could explore other factors related to promoting engagement and uptake when creating parent-directed KT tools for a range of health-related contexts.

Most vaccinations are administered with a needle, which can cause pain and pain-related symptoms such as fear and fainting. At present, interventions aimed at preventing pain and associated symptoms are not systematically integrated in the vaccination delivery process even though they contribute to negative experiences with vaccination and vaccination noncompliance. In this article, a novel framework for vaccination delivery called the CARD™ system was reviewed. CARD is an acronym for Comfort, Ask, Relax and Distract, whereby each letter category incorporates evidence-based interventions to reduce pain and fear and related symptoms. CARD can be integrated in usual vaccination planning and delivery activities in many settings to improve the vaccination experience and decrease pain and fear as barriers to vaccination. Immunizers in all settings and organizational leaders are invited to review their vaccination services against CARD to identify opportunities for enhancing the quality of care being provided.

La plupart des vaccins sont administrés avec une aiguille, ce qui peut provoquer des douleurs et des réactions liées à la douleur, tels que la peur et l’évanouissement. À l’heure actuelle, les interventions visant à prévenir la douleur et les réactions connexes ne sont pas systématiquement intégrées dans le processus d’administration de vaccins, bien qu’elles contribuent aux expériences négatives de la vaccination et à la non-adhésion occasionelle. Cet article examine une nouvelle démarche pour l’administration de vaccins, appelée le système CARDMC. CARD est l’acronyme de Confort, Aide, Relaxation et Distraction, où chaque lettre est associée à une catégorie d’interventions fondées sur des preuves pour réduire la douleur, la peur et les réactions connexes. Le système CARD peut être intégré dans les activités habituelles de planification et d’administration des vaccinations dans de nombreux contextes afin d’améliorer l’expérience de vaccination et de réduire la douleur et la peur qui font obstacle à la vaccination. Les vaccinateurs de tous les milieux et les responsables des organisations sont invités à revoir leurs services de vaccination par rapport au système CARD afin de cerner les possibilités d’améliorer la qualité des soins fournis.

Aims The aim of this study was to evaluate an educational pamphlet that incorporates evidence-based pain mitigation strategies during adult vaccine injections and determine its effect on the knowledge, attitudes, and behaviors toward use of such strategies among adults in the community receiving immunizations. Methods An evidence-based pamphlet about how to reduce pain during vaccination in adults was distributed to a convenience sample of community sites that administer vaccines, including family physician offices, travel clinics, and pharmacies. Providers at the community sites distributed a baseline (pre) questionnaire followed by the pamphlet to study participants. Then participants were vaccinated. Six weeks later, participants were contacted to complete a follow-up (post) questionnaire. Participants’ knowledge, attitudes, and behaviors regarding pain mitigation strategies for vaccine injections were evaluated before and after access to the pamphlet. Results Seventy-four people receiving vaccines participated. Participants were predominantly university educated (69%) and female (66%), with a median age of 44.5 years (range, 18–71). Most participants received an injection at a travel or public health clinic (73%). Twenty-seven percent had prior accurate knowledge of pain mitigation strategies. Self-reported pain or fear of needle pain did not change from before access to the pamphlet to six weeks after. Twenty percent of participants used at least one strategy outlined in the pamphlet and found it helpful and 52% were interested in sharing the pamphlet with others. Conclusions An educational pamphlet about vaccination pain mitigation resulted in a positive change in knowledge and attitudes around pain mitigation strategies. Further research is needed to explore long-term impact.

Background Pain and fear during immunizations can affect children and their future behaviour toward immunization. These negative experiences can be amplified when children receive vaccines as part of school-based immunization programs, where parental or tutor supports are missing. In 2015, HELPinKIDS&ADULTS, a Canadian network of experts, published a clinical practice guideline (CPG) on the management of pain and fear during immunization. This guideline has been endorsed by international, national and provincial organizations. However, the level of integration and implementation of the CPG into local and community immunization programs such as school-based immunization clinics is unclear. Methods An investigation whether public health units in Ontario integrated and implemented the pain and fear interventions recommended by the CPG into school-based immunization policies and practices was concluded. Results The study shows that the majority of public health units do have pain and fear policies and procedures in place, but interventions are not integrated in a consistent and formal manner, leading to suboptimal uptake of interventions during immunizations at school. Conclusion For pain interventions to be applied with sufficient fidelity and in enough individuals to have a meaningful effect, organizational leaders need to create directives and procedures that support implementation in a systematic and accountable manner.

Objective To metasynthesize the results of qualitative studies on the factors that affect parents' participation in pain management for their infants during procedures in the NICU. Data Sources We conducted a literature search for articles published from 1976 through November 2019 using MeSH terminology in the following databases: MEDLINE, CINAHL Plus, EMBASE, PubMed, PsycINFO, Cochrane, Scopus, and Web of Science. All qualitative studies in which researchers explored parental participation and education in the NICU were included. Study Selection A total of 29,937 articles were returned. Once we removed duplicates and limited results to qualitative studies, 48 articles remained. We excluded 41 articles because the studies reported were not conducted in NICUs, involved neonatal palliative care, or were review or opinion articles. We included seven articles for review. Data Extraction Two authors reviewed all articles using the Critical Appraisal Skills Programme tool to assess study quality and independently scored each study. We reviewed and extracted authors, publication date, type of study, sample size, results, themes, and quotes and included these data elements in the analysis. Data Synthesis We used a thematic synthesis technique to review the qualitative data, entered codes into NVivo software, and compared codes to create descriptive themes. From these descriptive themes, we generated four analytic themes: Learning to Parent a Hospitalized Infant, Stress and Anxiety, Health Care Providers as Gatekeepers, and NICU Environment. Conclusion The four themes identified in this qualitative metasynthesis represent the factors that affect parents' abilities to participate in their infants' pain management. Further research is recommended to develop interventions that address these factors to optimize parents' participation in pain management for their infants during procedures in the NICU.

The CARD (Comfort Ask Relax Distract) system is a vaccine delivery framework that integrates evidence-based interventions to reduce stress-related responses and improve the vaccination experience for children undergoing vaccinations at school. In preliminary studies, CARD was acceptable and effective. The objective was to evaluate CARD in a large, pragmatic trial to confirm its effectiveness in real-world settings.Hybrid effectiveness-implementation cluster randomized trial in schools receiving vaccination services from Wellington-Dufferin-Guelph Public Health. Forty schools with grade 7 students (12 years old) were randomized to CARD and control (n = 20/group). Nurses in CARD schools planned clinics with principals and educated students about CARD ahead of time. Principals disseminated information to staff and parents and sent reminders. Vaccination day processes minimized fear and facilitated student self-selected coping strategies. Nurses in control schools followed usual practices, which excluded principal meetings, education, reminders, and systematic integration of fear-reducing or child-selected coping strategies. Outcomes included stress-related symptoms (fear - primary outcome, pain, dizziness, fainting, post-vaccination reactions), use of coping interventions, vaccination uptake, attitudes and implementation outcomes (acceptability, appropriateness, feasibility, fidelity).Altogether, 1919 students were included. Fear and pain were lower in CARD schools: OR 0.65 (95% CI 0.47-0.90) and OR 0.62 (95% CI 0.50-0.77), respectively. No students fainted in CARD schools compared to 0.8% in control (p = 0.02). Dizziness and post-vaccination reactions did not differ. Student-led coping interventions were used more frequently in CARD schools. Vaccination uptake was 76.1% in CARD schools and 72.5% in control schools (OR 1.13 (95% CI 0.85-1.50)). Staff and students had positive attitudes about CARD and implementation outcomes; however, recommendations were made to improve fidelity.CARD reduced stress-related responses in students undergoing vaccinations at school and was positively received by students and public health staff. CARD is recommended to improve the quality of vaccination delivery services.NCT03966300.

Drug-associated harm is common but difficult to detect in the hospital setting. In critically ill children, we sought to evaluate drug-associated hepatic injury following enteral acetaminophen error, defined as acetaminophen dosing that exceeds daily maximum recommendations. This retrospective cohort study took place in two pediatric intensive care units within a pediatric hospital center. The included patients are children ( 18 years of age) admitted to the pediatric and cardiac intensive care unit between January 2008 and January 2018, and receiving enteral acetaminophen. We defined acetaminophen dosing error as exceeding daily acetaminophen dosing by 10% the upper limit of maximum recommended dose for weight and age ( 82.5 mg/kg/day or 4400 mg/day). We included 14,146 admissions, who received 147,485 doses of acetaminophen. Acetaminophen dosing errors occurred 1 in every 9.5 patient-days on acetaminophen. ALT and AST decreased significantly over the course of ICU admission (p 0.0001). In patients with acetaminophen errors, ALT and AST measured in the 24 to 96 h post error were not significantly different than when measured outside this window. A sensitivity analysis using 100 mg/kg/day as the upper daily acetaminophen error cut-off did not reveal any subsequent significant increase in ALT or ALT in the 24 to 96-h post-error window, compared to measurements taken outside the window.Although the administration of acetaminophen in critically ill children frequently exceeds the daily recommended limit and vigilance is needed, we did not find any associated increase in liver transaminases following acetaminophen errors.• Acetaminophen dosing errors are common in pediatric outpatients. • Excessive acetaminophen dosing can be associated with harm, including hepatic injury.• Exceeding daily acetaminophen dosing limit occurs 1 in every 9.5 patient-days in children admitted to the critical care unit. • In patients with daily dose excess of acetaminophen, we did not find a significant increase in the measured liver enzymes in the 24 to 96 h following the overdosing.

Background Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada. Methods In a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student’s choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™. Results Nine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation. Conclusion While most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations. Trial registration The trial is registered at ClinicalTrials.gov (NCT03948633); Submitted April 24, 2019.

Needle procedures are among the most common causes of pain and distress for individuals seeking health care. While needle pain is especially problematic for children needle pain and associated fear also has significant impact on adults and can lead to avoidance of appropriate medical care. Currently there is not a standard definition of needle pain. A taxonomy, or classification system, for acute needle pain would aid research efforts and enhance clinical care. To meet this need, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the U.S. Food and Drug Administration, the American Pain Society, and the American Academy of Pain Medicine formed the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks-American Pain Society-American Academy of Pain Medicine Pain Taxonomy initiative. One of the goals of this initiative was to develop taxonomies for acute pain disorders, including needle pain. To accomplish this, a working group of experts in needle pain was convened. Based on available literature and expert opinion, the working group used a 5-dimenional structure (diagnostic criteria, common features, modulating factors, impact and/or functional consequences, and putative mechanisms) to develop an acute pain taxonomy that is specific needle pain. As part of this, a set of 4 diagnostic criteria, with 2 modifiers to account for the influence of needle associated fear, are proposed to define the types of acute needle pain. PERSPECTIVE: This article presents a taxonomy for acute needle pain. This taxonomy could help to standardize definitions of acute pain in clinical studies of patients undergoing needle procedures.