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Immunization Site Pain: Case Definition and Guidelines for Collection, Analysis

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Immunization Site Pain: Case Definition and Guidelines for Collection, Analysis Vaccine 30 (2012) 4558–4577 Contents lists available at SciVerse ScienceDirect Vaccine j ournal homepage: www.elsevier.com/locate/vaccine Immunization site pain: Case definition and guidelines for collection, analysis, ଝ and presentation of immunization safety data a,∗ b c d e Jane F. Gidudu , Gary A. Walco , Anna Taddio , William T. Zempsky , Scott A. Halperin , a f g h i Angela Calugar , Neville A. Gibbs , Renald Hennig , Milivoj Jovancevic , Eva Netterlid , j k l,1 m n Terri O’Connor , James M. Oleske , Frederick Varricchio , Theodore F. Tsai , Harry Seifert , n 2 Anne E. Schuind , The Brighton Immunization Site Pain Working Group a Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA b Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, Seattle Children’s Hospital, Seattle, WA, USA c Division of Clinical, Social and Administrative Pharmacy, Leslie L. Dan Faculty of Pharmacy, University of Toronto and Child Health Evaluative Sciences, the Hospital for Sick Children, Toronto, Ontario, Canada d Division of Pain and Palliative Medicine, Connecticut Children’s Medical Center, University of Connecticut School of Medicine, Connecticut, USA e Department of Pediatrics and Microbiology & Immunology, Pediatric Infectious Diseases, Canadian Center for Vaccinology Dalhousie University Halifax, Nova Scotia, Canada f Division of Anesthesia, Analgesia and Rheumatology Products, Food and Drug Administration, USA g Scratch GbR, Pharmacovigilance Services, Butzbach, Germany h University of Zagreb, Croatia i Swedish Institute for Communicable Disease Control, Sweden j Bureau of Community Health Systems I Northcentral District Pennsylvania Department of Health, USA k Division of Pulmonary, Allergy, Immunology & Infectious Diseases Department of Pediatrics, New Jersey Medical School, New Jersey, USA l Food and Drug Administration, Rockville, MD, USA m Novartis Vaccines, Cambridge, MA, USA n GlaxoSmithKline Biologicals, King of Prussia, PA, USA a r t i c l e i n f o Article history: Received 13 March 2012 Accepted 29 March 2012 Available online 18 April 2012 Keywords: Immunization site pain Adverse event Immunization Guidelines Case definition 1. Preamble 1.1. Need for developing a case definition and guidelines for immunization site pain as an adverse event following immunization [AEFI] ଝ Disclaimer: The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working Pain is defined as “an unpleasant sensory and emotional experi- group. They do not necessarily represent the official positions of each participant’s ence associated with actual or potential tissue damage, or described organization (e.g., government, university, or corporation). Specifically, the findings in terms of such damage” (International Association for the Study and conclusions in this paper are those of the authors and do not necessarily rep- resent the views of the Centers for Disease Control and Prevention or the Food and of Pain, IASP) [1]. Pain is the most frequent local adverse event fol- Drug Administration. lowing immunization (AEFI) [2–5]. It results from the stimulation of ∗ Corresponding author. Tel.: +1 404 639 8472. nociceptive sensory neurons at the time of vaccine administration E-mail addresses: [email protected], [email protected] or inflammatory process in the damaged tissue afterward. (J.F. Gidudu). 1 Retired. To date, there has not been a commonly accepted, standard- 2 Brighton Collaboration homepage: http://www.brightoncollaboration.org. ized definition and related assessment of immunization site pain 0264-410X/$ – see front matter. Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.vaccine.2012.03.085 J.F. Gidudu et al. / Vaccine 30 (2012) 4558–4577 4559 as an AEFI [6–15]. This hinders comparability and uniform reporting 1.3. Rationale for selected decisions about the case definition for of pain across study settings or surveillance systems. Establishing immunization site pain as an AEFI criteria for assessing immunization site pain during and follow- ing immunization is important for individuals collecting, analyzing, It was the consensus of the Working Group (WG) to define presenting and/or communicating data on immunization pain as immunization site pain as an adverse event from an epidemiolog- AEFIs. ical or clinical stand point for use in both clinical trials and post A previous Brighton working group identified a list of local reac- marketing surveillance systems. To achieve this objective, the WG tions from coding terminologies [16–18] for injection site AEFIs agreed to use the IASP definition of pain, as specified in Section 1.1. that included a general term to describe “a local reaction” as well The case definition was subsequently categorized into three levels as more specific local reactions, including pain. Some definitions of diagnostic certainty according to the methods of pain assessment for local reactions have been defined and are published [19–24]. used (Section 2). In this manuscript, we describe the case definition and guidelines for the assessment of pain as a specific local reaction. The case 1.3.1. Scope of definition and components of pain definitions for published local reactions can be accessed at the The scope of the case definition was originally proposed to Brighton Website through a free online e-mail subscription process include pain that develops in the minutes to hours following https://brightoncollaboration.org/public/resources.htm. vaccination (delayed pain). However, the WG expanded the case Sections 2 and 3 of this paper provide the case definition and definition to include pain that develops in response to vaccine guidelines for data collection, analysis, and presentation that the administration (acute pain) as well. As a result of the change in Brighton Collaboration Local Reactions Working Group has devel- the original scope of the case definition, the WG agreed to broaden oped for the standardized collection and assessment of information the original title of this AEFI from “Pain at or near injection site” to about immunization site pain. Widespread use of this definition “Immunization site Pain.” with its guidelines will improve data comparability and allow for It was acknowledged that acute pain in response to vaccine a better understanding of immunization pain. The case definition administration is the synergistic effect of anxiety and nociception and guidelines are intended to be applicable in diverse geographic, and in practice it is difficult to separate the two. The subjective administrative, and cultural settings, regardless of differences in experience of pain and distress may or may not be directly linked the availability of health care resources. to a behavioral manifestation and for children, child–parent inter- actions and/or clinician biases may affect judgments about a child’s pain. The WG agreed to develop a definition that focuses on immu- 1.2. Methods for the development of the case definition and nization pain, but recognized that pain and distress cannot be easily guidelines for immunization site pain as an AEFI separated. The WG agreed to include both needle injection pain and needle-free injection pain in the case definition; noting that pain Following the process described previously [25], a Brighton Col- may be experienced from a variety of administration techniques, laboration Local Reactions Working Group was formed in December not just needle puncture through the skin. 2008 with 19 inter-disciplinary members with public health, The working group acknowledges that (1) technique, (2) meth- regulatory, clinical, academic, industry backgrounds, as well as ods of immunization administration and (3) immunization site expertise in pain. In January 2009, the working group began to identification (see Appendix C) are important in the assessment of develop the current definition of “immunization site pain” together pain. Studies have shown some associations with these 3 aspects with guidelines for data collection, analysis, and presentation of to pain experience [26,27,13,28]. However, these aspects are out- vaccine safety data. side the scope of this document. Capturing this information could To guide the decision-making for the case definition and be considered depending on the study question and if deemed of guidelines, a literature search was conducted using English and value in specific studies or field investigations. non-English citations of immunization site pain in the context The working group recognizes that the field of pain is evolving of immunization. The literature search was performed within and over time new approaches of pain assessment may emerge. Medline, the Cochrane library, and Embase from 1966 to April Similarly, other methods of delivering vaccines are evolving with 2001 with the following search terms: pain, local reaction, local increasingly lesser emphasis on the use of “needles” in delivering inflammation, injection site reaction nociception, injection pain, vaccines. needle pain, vaccines/complications, vaccines/contraindications, The working group considered muscular (myalgia) and joint vaccines/toxicity, immunization/adverse effects, vaccines/adverse (arthralgia) pain; however, it was decided not to address these effects, immunization/complications, immunization/toxicity, aspects in the definition of immunization site pain. immunization/contraindications, and humans. The search resulted in the identification of 1620 references
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