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Safety of high-concentration nitrous oxide by nasal mask fo r pediatric procedural sedation: experience with 7802 cases. Pediatr Emerg Care , 27 , 1107 \200\2231112 . CHAPTER 19 Needle procedures Anna Taddio Summary All children undergo needle procedures as part of routine medical care. Numerous in terventions are available for relieving pain from needle procedures. Th ese interventions c an be divided into four domains (4 Ps of pain management): procedural, pharmacological, psy chological, and physical. Treating needle pain reduces pain and distress and improves satis faction with medical care. Other potential benefi ts include a reduction in the development of needle fear and subsequent health care avoidance behavior. Adoption of the 4Ps into rou tine clinical practice is feasible and should become a stand- ard of care in the delivery o f health care for children. Th is chapter is a narrative review of the current knowledge ab out: epidemiology, pain experience, practices and attitudes, and evidence-based inter- vent ions for pain management during common needle procedures. reported by diff erent individuals. In general, children report nee- dle procedures as bein g more painful than adults do (Goodenough et al., 2008; Schneider and LoBiondo-Wood, 1992) and regard any procedure involving a needle as one of the most frightening and painful heal th-related events (Cummings et al., 1996; Ellis et al., 2004; Humphrey, 1992). Th e majorit y of young children exhibit moderate-severe distress during needle procedures (wherein dis- tress encompasses the combined eff ects of anxiety and pain). Since current methods of pai n assessment do not allow pain to be dif- ferentiated from anxiety, pain responses in young children include anxiety responses as well. In one study of immunization injec- tions, ove r 90% of children aged 15 to 18 months and 45% of those aged 4 to 6 years were seriously di stressed (Jacobson et al., 2001). In two separate studies of venepuncture, 64% of 3 to 6-ye ar-olds (Fradet et al., 1990) and 83% of 2 - to 6-year-olds (Humphrey et al., 1992) had hi gh distress. Th e percentage with high distress decreased with increasing age: 51% and 28% for 7 to 12 years and 12 years and greater, respectively (Humphrey et al., 1992). Introduction Despite their vital importance, needles are regarded as the negative symbol of health care (Schechter, 2006). Th is is because they cause anticipatory anxiety and pain. Th e needle is particularly concern- ing to children, who regard any procedure involving a needle as one of the most frightening and painful health-related events. Needle procedures undertaken in infancy and childhood may impact on how pain is perceived i n the future by altering the normal development of pain processing pathways (Fitzgerald and Walker, 2009) or by leading to the development of needle fears (Bijttebier and Vertommen, 1998; Chen et al., 2000; Jacobson et al., 2001; Rocha et al., 2003). Increased level of fea rfulness, lower sense of control over health, and distrust of adults, particu- larly health providers, can occur aft er experience with repeated needle procedures in childhood as wel l (Rennick et al., 2002; Salmela et al., 2011) and such procedures may be perceived as more traumatic than the underlying disease (Hedstrom et al., 2003; Ljungman et al., 1999). Epidemiology of needle procedures Injections, venepunctures, and venous cannulations are am ong the most prevalent needle procedures undertaken in children and are the focus of this c hapter. Injections consist primarily of intramuscular or subcutaneous administration of vac cines, and are experienced repeatedly throughout the lifespan. In the US, healthy children undergo over four dozen separate vaccine injections by the time they are adults (<http://ww w.immunize.org/catg.d/p4050.pdf>). Venepunctures and venous cannulations are the most commo n sources of needle pain for hospitalized children (Ellis et al., 2002; MacLean et al., 200 7; Stevens et al., 2011; Zhu et al., 2012). In one study, venepuncture and venous cannulati on accounted for almost two needle procedures per day among neonates in the fi rst week of life (Stevens et al., 2003). In another study including hospitalized children of all ages, the mean frequency of all common needle pro- cedures together was one every other day (Stev ens et al., 2011). Recent studies demonstrate that about two-thirds of children have a fear of needles (Taddio et al., 2012c; <http://www.painfoun- dation.org/media/resources/pain-surveys.html>). Needl e fears may be carried into adulthood whereby it is estimated that about one- fourth of adu lts are afraid (Taddio et al., 2012b) and one in ten have an outright phobia (Hamilton 1995 ). Th ese fears place individuals at risk for adverse health and lifestyle consequences (So kolowski et al., 2010). Individuals demonstrate health avoidance behav- iours, including ab stinence from: preventive health measures (e.g. immunizations, dental visits; Johnson et al ., 2008; Sokolowski et al., 2010; Wright et al., 2009) and treatment interventions, even li fe- saving ones (e.g. diabetes management; Howe et al., 2011). Refusal of needle procedures can lead to social and legal consequences as well, including refused travel, education, em ployment, marriage, or Clinical impact of needle procedures Although needle procedures are generally regarded as a source of \200\230mild \200\231 acute pain, there is substantial variability in the level of pain CHAPTER 19 needle procedures 185 pregnancy (Sokolowski et al., 2010). Reduced herd immunity from low immunization compliance rates may lead to outbreaks of vac- cine-preventable diseases (Diekema, 2012; Omer et al., 2009). can be categorized into four domains: \200\230 P rocedural \200\231 techniques that operat ors can use when performing the procedure; and \200\230 P harmacological \200\231, \200 \230 P sychological \200\231, and \200\230 P hysical \200\231 techniques that parents, ope rators, and children can use to modify the experi- ence of pain for children; herein referr ed to as the \200\2304 Ps \200\231 of pain management. Th e remainder of this chapter revi ews examples of interventions within these domains. Figure 19.1 illustrates the time- line for their use to mitigate pain from needle procedures under- taken in children. Systemic an algesics and adjuvant interventions are reviewed separately, in chapters in Section 6. Needle procedures carried out in children are also concern- ing for parents and clinicians. Alterations in physiological parameters (blood pressure, heart rate) and increased anxiety are documented for parents of children undergoing needle pro- cedures (Smith et al., 2007) . Both parents and clinicians report non-compliance with immunization in an eff ort to redu ce pain in children (Harrington et al., 2000; Madlon-Kay and Harper, 1994; Woodin et al., 1 995). Procedural interventions Th e best way to manage pain is to avoid it. Use of non-invasive t echnology is one way of avoiding pain \200\224 for instance, needle-free immunization (e.g . intranasal infl uenza vaccine) or non-invasive sampling devices (e.g. transcutaneous bili rubinometry; Yap et al., 2004). Children should undergo the minimum number of proce- dures possible. Th is is particularly important for hospitalized chil- dren, who frequently under go unnecessary procedures due to lack of communication and coordination among hospital pers onnel. For children requiring ongoing or repeated intravenous access, long- term indwelling catheters can be inserted. With respect to injec- tions, combination vaccines can be used rather than single-antigen ones to minimize the number of separate injections (Zareba, 2006 ). Health care providers undertaking needle procedures can uti- lize a variety of approache s to mitigate pain, including selecting one particular procedure over another and using spe cifi c tech- niques to carry out a procedure. For example, blood sampling can be performed using venepuncture instead of heel lance (Shah and Ohlsson, 2011). For intramuscular immuni zation injections, injec- tions can be carried out quickly without prior aspiration (Taddio et al., 2009a). When multiple injections are being given sequen- tially, pain can be reduc ed if the most painful one is administered last (Taddio et al., 2009a). Pain management practices and attitudes Historically, there has been under-utilization of p ain-relieving inter- ventions for needle procedures performed in children. Several audits c onducted over the last decade reveal wide variations in practices (Carbajal et al., 2008; E llis et al., 2002; Johnston et al., 2011; MacLean et al., 2007; Simons et al., 2003; Steven s et al., 2003; Chan et al, 2013; Zhu et al., 2012). Studies in hospitalized children, for instance, doc- ument pain-relieving interventions in 0% to 90% of needle proce- dures. Stud ies in neonates report higher utilization rates than those involving all ages of children. Intramuscular or subcutaneous injec- tions are associated with higher utilization rates tha n venepuncture and venous cannulation. In one study comparing two time points, a lower numb er of procedures were documented in the more recent time period, suggesting a reduction in the burden of pain over time in hospitalized infants (Johnston et al., 2011). Th is fi ndin g contrasts with the outpatient setting, where the burden of pain has been stead- ily incre asing over time due to the continual increase in the number of vaccines being introduced in to routine clinical practice. Taking care of a child \200\231s pain is important to parents (Ammentorp et al., 2005). Par ents are prepared to wait longer and to pay to reduce their child \200\231s pain (Meyerhoff et al., 2001; Myrick and Barfi eld 2006; Walsh and Bartfi eld 2006; Wasserfallen et al., 2 006). Clinicians regard pain management as the parents \200\231 responsibility. Th ey focus on the technical aspects of a child \200\231s medical care, forgoing children \200\231s (a nd parents \200\231) experiences of that care, including associated pain. With respect to n eedle procedures, clinicians oft en hold a proce- dure-focused, rather than child-focused v iew, and dismiss concerns about pain by describing it as a self-limited process. Dismissive atti- tudes about pain in clinicians results in parental acceptance of pain as \200\230th e necessary evil \200\231 that must be traded-off to obtain good health in their children ( Parvez et al., 2010). Since the physicochemical properties of the injectate can also infl uence pain, eff orts sh ould be made to administer the least pain- ful formulation of a medication. In separate sys tematic reviews, pain from lidocaine infi ltration (Cepeda et al., 2010) and mea- sles \200 \223mumps \200\223rubella vaccine injection (Taddio et al., 2009a) were reduced when a more physiological pH formulation was used. Such buff ered lidocaine solutions, however, are no t commercially avail- able as they are not stable. Th ey can be compounded prior to injec- tion by adding 1 ml of sodium bicarbonate 8.4% to 9 ml of lidocaine 1% (Cepeda et al., 2010 ). Buff ering is not recommended for vac- cines as the eff ect on immunogenicity is not kno wn. Since parents value pain management and pain management improves the quality of care that i s delivered, it follows that the societal value of pain management is high. Pain management should thus be incorporated within the process of all needle procedures (Wasserfallen et a l., 2006). Parents, health care providers, and institutions must part- ner together to addr ess barriers to best practices. Th e model of family- centered care may serve as a theoreti cal framework for this partnership (Franck and Callery, 2004). Briefl y, this model describ es participation of the family in children \200\231s health care and in decision-making in order to achieve optimal health care delivery in children. Th e temperature of the injectate may also aff ect pain. Lidocaine solutions that are warme d to body temperature, for example, cause less pain during infi ltration, even if the lidoc aine is buff ered (Hogan et al., 2011b). No benefi t has been observed for warmed vaccines, and thus, is not recommended for vaccinations (Taddio et al., 2009a). Pharmacological interventions A variety of pharmacological interventions are available for reduc- ing pain from needle procedures. Th e most common are local anesthetics and sweet so lutions. Evidence-based interventions for pain management Th ere are numerous eff ective, safe, and feasible interventions for managing pain from needle procedures. Th ese interventions Local anesthetics Local anesthetics are the most studied class of pharmacological intervent ions for reducing pain from needle procedures in children. SECTION 4 pain in specific populations and diseases 186 >1 hour to 1 hour 1 to 2 minutes Strategies at time of needle procedure Less painful procedure \200 Less painful injectate \200 For vaccine injections: Rapid I M injection without aspiration, most painful last Procedural Strategies Positioning upright/holding \200 Tactile stimulation near site Physical Strategies Distraction \200 Deep breathing Psychological Strategies Breastfeeding \200 Sugar water \200 Non-nutritive sucking \200 Facilitated tucking/sw addling Infant Strategies EMLA (lidocaine-prilocaine 5%) \200 AMETOP (tetracaine 4%) \200 MAXILENE (liposom al lidocaine 4%) Pharmacological Strategies Education \200 Preparation Family & Child Figure 19.1 Timeline for pain relieving strategies prior to and during needle procedures: p rocedural, physical, psychological, and pharmacological strategies (plus infant and family/ child). IM = intramuscular. Local anesthetics provide analgesia by blocking nociceptive trans- mission in nerve cells. Th ey are administered to the site of the nee- dle procedure using non-invasive (i.e. topic al) and invasive (i.e. needle) methods. Table 19.1 Commercially available topical anesthetics Topical anesthetic Availability Recommended application duration in minutes Table 19.1 summarizes currently marketed products that are applied topically on intact skin and rely on passive diff usion to achieve dermal anesthesia. Depending on the product, cli nically reliable local anesthesia is achieved aft er a contact time of 20 to 60 min. Commer cial preparations available in a disc/patch formula- tion have the local anesthetic embedde d within the delivery sys- tem and are adhered to the skin. Other preparations require that the appropriate dosage (usually about 1 g) be applied to the skin in a mound, and then cov ered with an occlusive dressing. Occlusion facilitates absorption of the anesthetic and pre vents accidental removal and/or ingestion. It may be necessary to apply topical anesthetics to more than one body region (or site) to account for multiple procedures. Care must be ta ken, however, to ensure that maximum recommended dosages are not exceeded in order to pre- vent systemic toxicity. Lidocaine 2.5% \200\224 prilocaine 2.5% Cream, patch 60 Lidocaine 7% \200\224 tetracaine 7% Heat delivery patch 20 Liposomal lidocaine 4% Cream 30 Tetracaine 4% Gel 40 Multiple systematic reviews and meta-analyzes have concluded that local anesthetics are eff ective and safe for reducing pain from common needle procedures (Fetzer, 2002; Lander et a l., 2006; Shah et al., 2009) (see also Zemspky, Chapter 47, this volume). Th ere is evidenc e that they may improve procedure success rate (e.g. insertion of indwelling cannula or pro curement of blood sample is achieved on the fi rst attempt) and reduce total procedure dura - tion time as well, presumably due to reduced pain and movement during procedures (Taddio et al., 2005b). One meta-analysis found tetracaine to be superior to lidocaine-prilocaine f or reducing pain from venepuncture (Lander et al., 2006), suggesting that not all preparati ons are equianalgesic. No diff erences, however, have been observed in procedural success r ate among various preparations (Arendts et al., 2008). Needle procedures are usually undertaken right aft er the required contact time has been me t and both the dressing and anesthetic have been removed. If a procedure is not undertaken immediately, a non-toxic marker can be used to mark the site where the anaes- thetic was ap plied \200\224 this prevents subsequent needle puncture in an unanaesthetized area. Attent ion should be given to the elapsed time following removal, as the anesthetic eff ect will b egin to fade thereaft er. Elapsed times of more than 1 h are not generally recom- mended in order to minimize the risk of analgesic failure. CHAPTER 19 needle procedures 187 Despite their demonstrated eff ectiveness, topical anesthetics are under-utilized for needl e procedures. Th is is due, at least in part, to perceptions about their eff ectiveness and feasibility. Th ere is an expectation that topical anesthetics will lead to painless needl e procedures. However, this is not usually the case. Pain perception is complex, and a resu lt of multiple interacting factors including anxi- ety and fear, which topical anesthetics may not eliminate. In addi- tion, anesthetics do not block all sensation \200\224 sensatio ns of pressure are still present, which may be interpreted by children and/or adults as pai n. Th e depth of penetration is several millimeters, resulting in partial blockade of nocic eptive input for most procedures. Finally, the presence of genetic polymorphisms may predis pose some chil- dren to analgesic failure (Kleiber et al., 2007). accompanied by strategies to reduce injection pain, including: buff - ering lidocaine with sodium bicarbonate (Cepeda et al., 2010) and warming the solution to body temperature (Hoga n et al., 2011b). More recently, novel technologies have been developed that allow for rapid administration o f local anesthetics without the need for needle puncture (Zempsky, 2008). For the most part , there is very limited experience with these technologies and they are not readily availab le in most clinical settings. Th ese technologies off er alter- native methods of administe ring local anesthetics and may come to have an important role in the management of cutaneou s pain in children in the future. Th ey are discussed in further detail by Zempsky (Chapter 47, this volume). With so many options available, the choice of which local anesthetic administration method to use depends primarily on: urgency of procedure, procedure site, child factors, availabil ity of equipment, and availability of experienced staff . If procedures are required urgent ly, only techniques with a short onset of action are suitable. For topical preparations, di sc/patch dosage modalities may be more convenient to use provided that the contact surface area and geography of body region allow them to be suitably applied. Th e presence of speci fi c child factors, such as age, distress levels, allergies, or child preferences lend them selves to the selection of certain preparations over others. Finally, the presence of requi site equipment and trained staff are needed to administer them.