Chambers, C., Taddio, A., Uman, L.S., McMurtry, M., and HELPinKIDS. (2009 ). Psychological interventions for reducing pain and distress during routine childhood immunizations: a syst ematic review. Clin Th er , 31 , S77 \200\223S103 . Chen, E., Zeltzer, L. K., Craske, M. G., and Katz, E. R. (2000 ). Children \200\231s memori es for painful cancer treatment procedures: implications for distress. Child Dev , 71 , 933 \200\223947 . Cheng, S. F., Foster, R. L., and Hester, N. O. (2003 ). A review of factors predicting chil dren \200\231s pain experiences. Issues Compr Pediatr Nurs , 26 , 203 \200\223216 . Cohen, L. L. (2008 ). Behavioral approaches to anxiety and pain management for pediatric venous access. Pediatrics , 122 , S134 \200\223S139 . Pain and anxiety might not be completely eliminated by use of pain-relieving interventions. Children may still be anxious because of negative previous experiences, unfamiliar individ uals and/or set- tings, or other reasons. Th ese circumstances in no way negate the use of pain-relieving interventions; instead, they call for additional interventions. Cohen, L. L., Bernard, R. S., Greco, L. A., and McClellan, C. B. (2002 ). A child-focused i ntervention for coping with procedural pain: are parent and nurse coaches necessary? J Pedi atr Psychol , 27 , 749 \200\223757 . Cummings, E. A., Reid, G. J., Finley, G. A., McGrath, P. J., and Ritchie, J.A. (1996 ). Pre valence and source of pain in pediatric inpatients. Pain , 68 , 25 \200\22331 . DeMore, M. and Cohen, L. L. (2005 ). Distraction for pediatric immunization Conclusion Attending to pain from needle procedures undertaken in chil- dren supports child ren \200\231s health because it: (1) reduces acute suff ering, which improves the experienc e of children undergo- ing needle procedures, their caregivers, and operators, and (2) redu ces long-term harms, including non-compliance with future health care interventions as a re sult of minimizing the develop- ment of needle fears. Numerous evidence-based and feasible pain: a critical review. J Clin Psychol Med Sett , 12 , 281 \200\223291 . Diekema, D. S. (2012 ). Improving childhood vaccination rates. N Engl J Med , 366 , 391 \200\223393 . Ellis, J. A., O \200\231Connor, B. V., Cappelli, M., Goodman, J. T., Blouin, R., and Reid, C. W. (2002 ). Pain in hospitalized pediatric patients: how are we doing? Clin J Pain , 18 , 262 \200\223269 . Ellis, J. A., Sharp, D., Newhook, K., and Cohen, J. (2004 ). 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(2008 ). Pharmacologic approaches for reducing venous access pain in children. Pediatrics , 122 , S140 \200\223S153 . Wasserfallen, J. B., Currat-Zweifel, C., Cheseaux, J. J., Hofer, M., and Fanconi, S. (2006 ). Parents \200\231 willingness to pay for diminishing children \200\231s pain during blood sampling. Pediatr Anesth , 16 , 11 \200\22318 . Zhu, L., Stinson, J., Palozzi, L., Weingarten, K., Hogan, M. E., Duong, S., et al . (2012 ) Improvements in pain outcomes in a Canadian pediatric teaching hospital following implemen tation of a multifaceted knowledge translation initiative. Pain Res Manag , 17 , 173 \200 \223179 . Woodin, K. A., Rodewald, L. E., Humiston, S. G., Carges, M. S., Schaff er, S. J., and Szila gyi, P.G. (1995 ). Physician and parent opinions: are children becoming pincushions from im munizations? Arch Pediatr Adolesc Med , 149 , 845 \200\223849 . Wright, S., Yelland, M., He athcote, K. and Shu-Kay, N. (2009 ). Fear of needles: nature and prevalence in general prac tice. Australian Family Physician , 38 , 172 \200\223176 . CHAPTER 20 Procedural sedation Joseph P. Cravero Summary Pediatric patients undergoing procedures oft en require sedation to provide the app ropriate combination of anxiolysis, analgesia, and motionlessness. Due to the behavioral an d developmental issues involved with this population, children actually require sedation to accomplish procedures much more oft en than adults. Pediatric seda- tion is a dynamic area of practice. Requests for this care continue to rise. Th e variety of providers involved i n this care has also increased signifi cantly. Th is chapter reviews the basic concepts inv olved in seda- tion delivery and then addresses the various considerations involved in seda tion cases from the point of view of patient factors, procedure factors, and provider facto rs. Various drugs available for sedation are also reviewed with comments on appropriate str ategies for a variety of common diagnostic and therapeutic procedures. Introduction Providi ng pain control for children requires recognition of the dis- tinct nature of this populati on when compared to adults. Emotional and behavioral issues change with every developmental stage. Even if pain can be controlled, the presence of strangers and medi- cal equipment w ill upset many children. Th e result can be unwanted physical and/or psychological trauma t o the child and diffi culty in accomplishing the procedure for the health care provider. As a result, sedation is sometimes required (in addition to analgesia) in order to provide op timal care. It is imperative that professionals who provide sedation clearly understand the concepts th at are the keys to sedation practice includ- ing the nature of sedation depth, sedation mon itoring, pharmacody- namics/pharmacokinetics of the sedative agents, core competencies for sedation management, and issues involving recovery of patients aft er sedation. It is only with a clear understanding of these concepts that the goal of safely eliminating pain and a nxiety from the experi- ence of hospital procedures and tests can be realized for children. Background Levels of sedation Professional organizations have defined sedation in different ways. The American Academy of Pediatrics (AAP) and the American Academy of Pediatric Denti stry (AAPD) (Cote and Wilson, 2006), the American Society of Anesthesiologists (ASA; ASA Ta sk Force on Sedation and Analgesia by Non- Anesthesiologists, 2002), and The Joint Commissi on (TJC; <http://www.TheJointCommision.com>) as well as the National Institute for Health a nd Clinical Excellence (NICE, 2010) in the UK have used the concept of levels of sedation r anging from minimally impaired consciousness to complete unconscious- ness or general anest hesia. On the other hand, the American College of Emergency Physicians prefers to refer to all sedation that is provided with the intent of accomplishing a test or proce- dure as \200\230procedural sedation \200\231 (Godwin, 2005) without emphasis on various depths of s edation. Over the last 30 years the delivery of sedation for children has changed considerably. Proc edural sedation was, and in many places still is, disseminated among a large group of provi ders with lit- tle organization or strategic planning and with wide variation in approach. Th e last 10 years has seen the formation of pediatric sedation services across North Ameri ca and Europe staff ed by a variety of specialists including anaesthesiologists, emergency medicine providers, intensivists, and hospital-based pediatricians (Cravero, 2009; Cravero et al., 2006, 2009; Rodrigo, 1991; Rodrigo et al., 1992; Weinbroum et al., 2001). Th ese hi ghly organized serv- ices have proven to be effi cient, safe, and have decreased variation, as tracked by the Pediatric Sedation Research Consortium (Cravero et al., 2006). Training in sedation has become a fundamental com- ponent of pediatric emergency medicine and intens ive care fel- lowships in the US, Europe, and Australia (Ilkhanipour et al., 1994; Mintegi et al., 2008). With these changes in care and training, the level of expectations for the d elivery of safe, effi cient, and highly eff ective procedural sedation has been raised sign ifi cantly. Any provider who delivers sedation should recognize that dif- ferent depths of sedation are possible and that risk for respiratory depression and cardiovascular changes are related t o depth of seda- tion. Furthermore, a drug does not determine the depth of seda- tion that results from its administration. Any sedative drug, given a large enough dose, will produce complete unconsciousness and potentially dangerous outcomes (Cote et al., 2000b). Th e pro vider of sedation should be able to manage or rescue a patient from any level of sedation a chieved. Th e current levels of sedation defi ned by the AAP/AAPD, ASA, and NICE guidelines for mana gement of patients during sedation include the following (Cote and Wilson, 2006): Minimal sedation A medically controlled state of depressed consciousness (formerly referred to as conscious sedation) which allows protective refl exes to be maintained; retains the patient \200\231s ability to maintain a patent airway CHAPTER 20 procedural sedation 195 independently and continuously; and permits appropriate response by the patient to physical stimulation or verbal commands such as \200\230open your eyes \200\231. Although cognitiv e function and coordination may be impaired, ventilatory and cardiovascular functions are u naff ected. Box 20.1 University of Michigan Sedation Score Level state: 0 = Awake/alert. 1 = Minimally sedated: tired/sleepy, appropriate response to Moderate sedation/analgesia A drug-induced depression of consciousness during which patient s respond purposefully to verbal commands, either alone or accom- panied by light tactile s timulation. No interventions are required to maintain a patent airway and spontaneous venti lation is adequate. Cardiovascular function is usually maintained. verbal conversation and/or sounds. 2 = Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation. 3 = Deeply sedated: deep sleep, arousable only with signi \201 cant physical stimulation. 4 = Unarousable Deep sedation A medically controlled state of depressed consciousness or uncon- sciousness from which the patient is not easily aroused. It may be accompanied by a partial or complet e loss of protective refl exes, and includes the inability to maintain a patent airway inde pendently and respond purposefully to physical stimulation or verbal command. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadeq uate. Cardiovascular func- tion is usually maintained. Copyright Th e Regents of the University of Michigan. Reprinted with permission from Mal viya S et al., Depth of sedation in children undergo- ing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS), British Journal of Anesth esia , Volume 88, Issue 2, pp. 241 \200\22325, 2002. Observer \200\231s Assessment of Alertness/Sedation Scale (Chernik et al., 1990), Comfort S core, Modifi ed Ramsey Sedation Score, and the Children \200\231s Hospital of Wisconsin Sed ation Scale (Ista et al., 2005). All of these scales measure levels of consciousness and ag itation while the Comfort Scale and the Modifi ed Ramsey Scale also include an assessment o f pain and ventilation. While the scales have been compared to one another in various studi es over the years, no specifi c scale has been shown to improve patient outcome or sedation provision over the others (De Jonghe et al., 2000). General anesthesia General anesthesia is a drug-induced loss of consciousness dur- ing whic h patients cannot be aroused, even by painful stimulation. Th e ability to independently ma intain ventilatory function is oft en impaired. Patients oft en require assistance in maint aining a patent airway and positive pressure ventilation may be required because of depress ed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovasc ular function may be impaired. Th e levels of sedation are not intended for use as a consta nt moni- tor of patient state. It is not practical to constantly stimulate patients to test their depth of sedation. Rather, these levels can be used to observe patient behavior and codify patient risk based on response to stimuli that might occur during the course of a pr ocedure. Planning for sedation Th ere are many factors that impact the manner in which sedation shou ld be provided. Every child should undergo a pre-sedation health assessment. Th is assessme nt should include age, weight, past medical history, vital signs, physical examination, and ASA status (Cote and Wilson, 2006). While the pre-sedation examination of the patient is undoubt- edly important in planning se dation for a procedure or test, this assessment is only one of a larger number of factors t hat must be considered including those related to the patient, the procedure, and the provi der. Sedation depth monitoring Th ere are several monitors of depth of anesthesia/sedation. Th e most commonly employed monitor is the Bispectral Index (BIS) monitor. Th is instrument use s a proprietary algorithm to process selected electroencephalographic (EEG) output into a n umber (from 0 to 100) that refl ects the depth of sedation. While some investiga- tors have validated its use during sedation of children (McDermott et al., 2003), it has not been fo und to be particularly useful during procedural sedation. Studies have found the BIS readin g does not match well with clinical assessment of the depth of sedation, par- ticularly whe n ketamine or combinations of sedation medications are utilized (Shields et al., 2005). Factors relating to the patient Past experience As part of a detailed sedation history prio r to the procedure the previous experiences of the patient should be elicited. For example, a patient who became combative with a dose of oral midazolam would not be well served by r epeating that drug for another proce- dure. Th e sedation provider should also consider the anxiety level of the patient and family. Th e severely anxious patient will oft en need si gnifi cantly more pharmacological sedation where a relaxed patient may only need support or distraction (Mintegi et al., 2008). Child life or play therapists can play an integral rol e in determin- ing the optimal strategy for managing each patient \200\231s emotional and p sychological needs (Brewer et al., 2006, Stevenson et al., 2005). Several sedation monitoring scales are available for use dur- ing sedation activity. Unfort unately most have been designed for sedation depth monitoring in the intensive care unit (I CU) environment and, in order to test the depth of sedation, most of them require stimulati on and documentation of response. Th e University of Michigan Sedation Score (UMSS) (Box 20 .1 ) has been widely used and has undergone testing for validity. It is simple to use (repe atedly) during the course of a sedation activity (Malviya et al., 2002; Mason et al., 2004) Other sedation scores include the Allergies and adverse reactions It is imperative that a drug allergy and adverse reaction h istory be elicited prior to providing sedation. Reports of an allergy to a given SECTION 4 pain in specific populations and diseases 196 medication should be followed up with a history of the nature of the reaction. Drugs that w ere associated with truly allergic symptomatol- ogy (such as rash or wheezing) should be av oided. Families commonly interpret nausea or odd behavior aft er sedation as an allergy. In fact these issues are oft en commonly known reactions to a medication or procedure. Nausea and vomiting are always possible aft er sedation \200\224 particularly with medications s uch as ketamine (Langston et al., 2008). Anticipatory treatment with 5HT3 inhibitors or ste roids may decrease nausea and vomiting eff ects (Gan et al., 2007). Approximately 2% of pat ients will have paradoxical reactions to sedative medications such as midazolam or chloral hydrate (Sakurai et al. 2010). In these cases crying and combative behavior is elicited sho rtly aft er administra- tion rather than the desired sedation. Observational studies sugges t the use of the benzodiazepine reversal agent romazicon can be useful in truncating the be havior (Rodrigo, 1991; Weinbroum et al., 2001). Emergence agitation has been described duri ng the recovery phase aft er sedation (Karaaslan et al., 2006). In these cases, patients ma y be delirious and combative for a period of 10 to 30 min (rarely longer) on awakening from sedation. gastro-oesophageal refl ux disease should be considered a risk fac- tor for pulmonary aspir ation during sedation or anesthesia (ASA Committee on Standards and Practice Parameters, 20 11). General health Th e general health status for each patient who presents for sedation should be assessed. A general physical examination with focus on the airway, cardiovascular, and respiratory systems is critical. Th e ASA status classifi cation system categorizes individuals based on a general health (A SA Committee on Standards and Practice Parameters, 2011) (Table 20.2 ). Rather than focus o n any specifi c disease entity, the ASA status is intended to group patients together based on their health status in order to better assess the risk of anaes- thesia or sedation. Se veral studies have documented that the risk for any complication during sedation (desaturat ion episodes, airway obstruction, hypotension) rises by four- to fi vefold with increasing ASA status (Cravero et al., 2009; Krauss and Green, 2008). Airway issues As part of the pre-sedation evaluation, specifi c abnormalities of the airway should be noted. Th ese issues can be divided into two gen- eral categories: (1) the diffi cult functional airway, and (2) the dif- fi cult anatomical airway (Sims and von Ungern-St ernberg, 2012). NPO status and assessment of aspiration risk Th e ASA and AAP (ASA Task Force on Preoperati ve Fasting, 1999, Cote and Wilson, 2006) guidelines have historically taken the approach th at anyone receiving moderate sedation or deep sedation should be treated similarly to those receiving anesthesia regard- ing the timing of oral intake to prevent aspiration (Table 20 .1 ) Th e authors argue that since sedation depth is variable it is possible that patients will enter a state where they will have impaired airway pro- tective refl exes even when mo derated sedation is targeted. Th e diffi cult functional airway refers to those patients who are expected to have diffi c ulty exchanging air through their natural airway when sedated. Children in this category wo uld include those with severe sleep apnoea, obesity, recurrent croup, mark- edly enlarged t onsils, or those with congenital anomalies that make sleeping supine diffi cult or impossib le (Donnelly et al., 2000). When children in this category are sedated to the point of unco n- sciousness, airway obstruction would be much more common than in healthy children (Adewa le, 2009). In the UK, NICE guidelines recommend nothing by mouth (NPO) intervals of 2 h for clear liqu ids, 4 h for breast milk, and 6 h for solids (NICE, 2010) Fasting is not recommended for in dividu- als who will receive minimal sedation or moderate sedation where verbal contact wil l be monitored and maintained throughout. Table 20.2 Outline of the ASA physical status criteria Recently, two retrospective reviews have questioned the application of these guidelines to the fi eld of pediatric sedation. Th ese studies reviewed the charts of over 2400 emergency department pediatric sedation encounters and found no relationship between NPO dura- tion prior to sedation and adverse outcomes (Agrawal et al., 2003; Roback et al., 2004). In ligh t of this data, the American College of Emergency Physicians has developed its own set of f asting guidelines that diff ers signifi cantly from the ASA (Green et al., 2007). ASA class Description 1 A normal, healthy patient, without organic, physiological, or psychiatric disturbance 2 A patient with controlled medical conditions without signi \201 cant systemic e \200 ects 3 A patient having medical conditions with signi \201 cant systemic e \200 ects intermitten tly associated with signi \201 cant functional compromise In addition to the history of oral intake, the ASA Practice Guidelines for Perioperative Fa sting recommend that a history of 4 A patient with a medical condition that is poorly controlled, associated with signi \201 c ant dysfunction and is a potential threat to life Table 20.1 ASA fasting guidelines for sedation or anesthesia Food Hours of fasting required 5 A patient with a critical medical condition that is associated with little chance of surviv al with or without the surgical procedure Clear liquids 2 Breast milk 4 6 A patient who is brain dead and undergoing anesthesia care for the purposes of organ donati on Formula or light meal (no fat) 6 Full meal 8 E Th is modi \201 er is added to any of the above classes to signify a procedure that is bei ng performed as an emergency and may be associated with a suboptimal opportunity for risk m odi \201 cation