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CHAPTER 115: Pain Management and Procedural Sedation for Infants and Children 723 Pain Management and Procedural Sedation for Infants and Children Samina Ali Naveen Poonai INTRODUCTION Pain is a common reason for an ED visit in children. Even children who do not initially present to the ED in pain often incur pain due to required medical procedures. There is ample evidence that children’s pain remains undertreated in the ED. 1-3 Barriers to optimal pain man agement include failure to use clinical tools for pain assessment, 4 poor documentation of pain,5,6 inadequate familiarity with pain management options, concerns regarding adverse effects, and perceived time con straints in a busy ED. Children who receive appropriate pain relief in the ED have sig nificant reductions in distress, improved rapport with the physician, improved intent to comply with discharge instructions, 7 and higher levels of personal and caregiver satisfaction. 8,9 Untreated pain in child hood leads to short- and long-term problems including anxiety, needle phobia, 10 hyperesthesia,11 and fear of medical care as adults. 12 Effective pain management is a cornerstone of high-quality care, supported by the World Health Organization, the American Academy of Pediatrics, and the Joint Commission on Accreditation of Healthcare Organizations. The experience of pain and distress in the ED is influenced by the patient (child age, prior experience with health providers, level of distress, developmental level); the illness (presenting complaint, pain severity, required procedures), and provider factors (skill level, ED resources). An appreciation of these elements should be the foundation for planning the approach to pain management. The key tools of analgesia, anxiolysis, and procedural sedation overlap and influence one another. Effective pain management begins at the initial triage assessment and continues with comprehensive discharge instructions (Figure 115-1). This chapter includes best evidence for the assessment of pain in children; physical, psychological, and pharmacologic strategies to manage both pain and distress; and methods for overcoming barriers to providing timely and effective analgesia.  ASSESSMENT OF PAIN AND DISTRESS The first step in the treatment of pain and distress in children is to quantify the severity of symptoms. The level of pain or distress may be obvious, as with a fracture, or less straightforward, as with abdominal pain or headache. Specific pain scales have been developed for children at different developmental stages and ages ( Table 115-1).

atment of pain and distress in children is to quantify the severity of symptoms. The level of pain or distress may be obvious, as with a fracture, or less straightforward, as with abdominal pain or headache. Specific pain scales have been developed for children at different developmental stages and ages ( Table 115-1). Physiologic parameters, such as heart rate, oxygen saturation, and blood pressure, in CHAPTER Triage Assess pain and distress Record pain score using age-appropriate tool Offer pharmacologic analgesia if necessary Initial Bedside Nursing Assessment Reassess pain and/or distress Record pain score using age-appropriate tool Offer pharmacologic analgesia if necessary Optimize psychological approach to pain management (child life specialist, distraction, etc.) Educate caregiver in comforting child Physician Assessment Assess effectiveness of analgesic strategies Record pain score using age-appropriate tool Offer pharmacologic analgesia if necessary Optimize physical approach to pain management (positioning, caregiver attendance, etc.) Optimize psychological approach to pain management (child life specialist, distraction, etc.) Physician/Nursing Reassessment Evaluate effectiveness of pain management strategies using age-appropriate tools Continue effective interventions Augment ineffective interventions Assess caregiver's distress and ability to comfort child and provide support as needed Optimize physical approach to pain management (positioning, caregiver attendance, etc.) Discharge Provide disease-specific approach to analgesia (splint, cast, steroids, etc.) Educate caregiver and child on importance of pain assessment following discharge Educate caregiver and child on psychological, physical, and pharmacologic strategies Discuss indications to return for inadequate at-home management of pain FIGURE 115-1. The continuum of pediatric pain assessment and treatment in the ED. Tintinalli_Sec12_p0669-0996.indd 723 8/2/19 7:50 PM

ssessment following discharge Educate caregiver and child on psychological, physical, and pharmacologic strategies Discuss indications to return for inadequate at-home management of pain FIGURE 115-1. The continuum of pediatric pain assessment and treatment in the ED. Tintinalli_Sec12_p0669-0996.indd 723 8/2/19 7:50 PM 724 SECTION 12: Pediatrics Face 0 – No particular expression or smile 1 – Occasional grimace or frown, withdrawn, disinterested 2 – Frequent to constant quivering chin, clenched jaw Legs 0 – Normal position or relaxed 1 – Uneasy, restless, tense 2 – Kicking, or legs drawn up Activity 0 – Lying quietly, normal position, moves easily 1 – Squirming, shifting back and forth, tense 2 – Arched, rigid, or jerking Cry 0 – No cry (awake or asleep) 1 – Moans or whimpers; occasional complaint 2 – Crying steadily, screams or sobs, frequent complaints Consolability 0 – Content, relaxed 1 – Reassured by occasional touching, hugging, or being talked to, distractible 2 – Difficult to console or comfort FIGURE 115-2. FLACC (Face, Legs, Activity, Cry, Consolability) Scale. [Reproduced with permission from National Institutes of Health (NIH).] TABLE 115-1 Assessment of Pain by Age: Currently Recommended Pain Scales Infants and toddlers (0–3 y) FLACC© (Face, Legs, Activity, Cry, Consolability) Scale (FLACC) Neonatal Infant Pain Scale (NIPS) Young children (4–8 y) Faces Pain Scale–Revised Older children and youth (6–18 y) Visual Analog Scale (VAS) Verbal Numeric Scale (VNR) isolation are inadequate to accurately assessing a child’s degree of pain and should not be used as the sole measures of pain intensity.14 After initial pain measurement, reassess pain intensity at appropriate intervals. Timing of reassessment is determined by the expected onset and peak of a medication’s actions. 15,16 Adopt pharmacologic, physical, and psychological strategies to minimize the impact of procedures and decrease stress. INFANTS AND TODDLERS <4 YEARS OLD A variety of observation-based pain scales have been developed for use in infants and young children, as they are unable to self-report and quantify pain. The FLACC Scale (Face, Legs, Activity, Cry, Consolability) (Figure 115-2) and the Neonatal Infant Pain Scale (Figure 115-3) are the currently recommended tools for pain assessment in children <4 years old. 17-19 An individual score of >6 on the FLACC is generally associated with a need for analgesia. For the Neonatal Infant Pain Scale (Figure 115-3), scoring is done over a 1-minute interval, and assigned scores can range from 0 (no pain) to 7 (most pain). The Neonatal Infant Pain Scale most accurately detects a change in an individual, but is limited in its ability to consistently describe a child at a single point in time. 20 A Neonatal Infant Pain Scale score >3 is generally associated with a need for analgesia. SCHOOL-AGED CHILDREN AND YOUTH Older children are often capable of self-reporting pain, using either a visual or numerical pain scale. Pain scoring varies widely from individual to individual, so trends in pre- and post-treatment pain scores provide the most objective and reliable method for assessing the effec tiveness of interventions. In children 4 to 12 years old, the Faces Pain Scale–Revised (Figure 115-4) is the most valid and reliable tool and is recommended especially for children who do not have the ability to serially numerate. 21,22 The Faces Pain Scale– Revised consists of six gender-neutral faces, which are scored from 0 to 10. The scale is easy to explain, quick to use, and requires minimal instruction for the child. It has been translated into >30 different languages and is free to use (https://www.iasp-pain.org/Education/Content.aspx?ItemNumber=1519).

Pain Scale– Revised consists of six gender-neutral faces, which are scored from 0 to 10. The scale is easy to explain, quick to use, and requires minimal instruction for the child. It has been translated into >30 different languages and is free to use (https://www.iasp-pain.org/Education/Content.aspx?ItemNumber=1519). For patients 8 to 18 years old, the Visual Analog Scale (Figure 115-5) can be easily used and requires only a print copy of the tool and a pencil. The Visual Analog Scale consists of a 100-mm line anchored on the left with “no pain” and on the right with “most pain. ” The child makes a mark on the line to indicate the pain level, and the distance is then measured from the left end point of the scale to the child’s mark; this distance, measured in millimeters, represents the child’s degree of pain. Minimum score is 0 mm, and maximum score is 100 mm. The Visual Analog Scale is valid and sensitive to changes over time and with analgesic interventions. The Verbal Numeric Rating Scale can be used in children ages 6 years to adulthood. 24 The Verbal Numeric Rating Scale is a verbally adminis tered scale that rates pain from 0 (no pain) to 10 (worst pain imaginable) and is the most frequently used self-report measure of pain intensity in older children and adults with acute pain. 25,26 Its appeal is due, in part, to the fact that it requires no equipment to administer or score. SPECIAL NEEDS CHILDREN Pain assessment and management in children with cognitive impair ments pose special challenges. Children with memory, language, or speech deficits or those with an altered level of consciousness may be unable to communicate verbally, which is the main mode by which most pain scales are administered. One should never assume that children who are differently abled lack the cognitive ability to self-report pain. In cerebral palsy, for example, the extent of physical disability can be incongruent with a child’s intel lectual capabilities. Whenever possible, use the standard pediatric self-report pain scale that matches the child’s developmental age (see previous section). If there are verbal communication difficulties, sub stitute observation-based assessment. 28,29 Indirect pain measures may introduce bias in the estimation of pain. It is not uncommon for parents of children with mild to moderate cognitive deficits to underestimate their child’s pain, whereas the opposite has been reported to occur in those children with severe cognitive deficits. Tintinalli_Sec12_p0669-0996.indd 724 8/2/19 7:50 PM

res may introduce bias in the estimation of pain. It is not uncommon for parents of children with mild to moderate cognitive deficits to underestimate their child’s pain, whereas the opposite has been reported to occur in those children with severe cognitive deficits. Tintinalli_Sec12_p0669-0996.indd 724 8/2/19 7:50 PM CHAPTER 115: Pain Management and Procedural Sedation for Infants and Children 725 0 point 1 point 2 points Relaxed Contracted Absent Mumbling Vigorous Relaxed Different than basal Relaxed Flexed/stretched Relaxed Flexed/stretched NIPS Facial expression Cry Breathing Arms Legs Alertness Sleeping/calm Uncomfortable – – – – – FIGURE 115-3. Neonatal Infant Pain Scale (NIPS). FIGURE 115-4. Faces Pain Scale–Revised (FPS-R). [©2001, International Association for the Study of Pain, www.iasp-pain.org/FPSR.] For children with a cognitive impairment that precludes the ability to self-report pain, there are several tools that have been developed and tested for this specific population, but the revised FLACC (r-FLACC) is the currently recommended tool, and although it is scored in the same manner as the FLACC, it allows comments for individualized child behavior, which can adjust the total score. Caregivers may offer valuable insight or access to unique communication aids (e.g., child-specific sign language or customized tablet software).  ACUTE PAIN TREATMENT Pain treatment consists of a multimodal approach of physical, psycho logical, and pharmacologic therapies. Assess initial pain and reassess after interventions. Base initial analgesic medication on pain intensity and escalate as needed. In most instances of mild to moderate pain, use nonopioid medications first, and add opioids as needed ( Table 115-2). Provision of early analgesia does not affect diagnostic accuracy. PHYSICAL INTERVENTIONS Encourage parental presence in almost all circumstances, taking into account family preferences. The parent can provide calm verbal sup port (“I’m here for you, ” “I love you”), distraction, companionship, and reassuring touch. If feeding is permitted, breastfeeding can be soothing for younger children; a pacifier can be used if breastfeeding is not pos sible or allowed due to NPO (nothing by mouth) status. Y oung infants can be tucked or swaddled with blankets during wait times. For skeletal injuries, use simple techniques such as early immobilization, application of ice or cold packs, and elevation. Cool compresses, dimmed lights, and minimizing noise in the child’s room may help with the treatment of headache. PSYCHOLOGICAL INTERVENTIONS Acknowledge the child first when entering the patient’s room, as this sets the tone and identifies the child as the focus of care. Parents also require some direction as to what to expect, how they can help with positioning and distraction, and how best to support their child. Simple distraction techniques can include bubbles, books, I-spy books/ cards, talking with the child, and storytelling. For older children, tablet devices, DVD players, smart phone games, music, videos, and virtual reality are good adjuncts. Many procedures are performed with the child recumbent, so visually engaging artwork on walls or ceilings can provide distraction. PHARMACOLOGIC TREATMENT Table 115-2 provides oral, intranasal, and parenteral analgesic options and dosing for acute pediatric pain.  ORAL NONOPIOID AGENTS Oral ibuprofen and acetaminophen are the mainstays of treatment for mild to moderate pain in children. Unless a specific contraindication to one of these exists, they should be used first. Ibuprofen is especially good for acute musculoskeletal injuries and is more effective than acetaminophen as monotherapy.

OID AGENTS Oral ibuprofen and acetaminophen are the mainstays of treatment for mild to moderate pain in children. Unless a specific contraindication to one of these exists, they should be used first. Ibuprofen is especially good for acute musculoskeletal injuries and is more effective than acetaminophen as monotherapy. 31 Although laboratory studies in tissue culture demonstrate inhibition of osteoblasts by NSAIDs, no human studies have demonstrated clinically significant delay in fracture healing from their use. When monotherapy with ibuprofen is inadequate or presenting pain is moderate, we suggest combining or alternating therapy with ibuprofen and acetaminophen. Combining ibuprofen with acetaminophen appears to provide similar pain relief to acetaminophen plus opioid and with a significantly better adverse event profile. 32-36  ORAL OPIOID AGENTS Oral morphine, oxycodone, and codeine do not appear to confer advantages as monotherapy or in combination with acetaminophen or ibuprofen compared to ibuprofen alone. 31,37-41 The U.S. Food and Drug Administration and Health Canada advise against the use of codeine in children <12 years old. 42,43 The U.S. Food and Drug Administra tion has also advised against the use of tramadol in children <12 years old. 44 Health Canada advises against the use of hydrocodone in children <6 years of age.  INTRANASAL FENTANYL Intranasal fentanyl is an excellent choice for rapid treatment of moderate to severe pain, especially if IV placement is not otherwise necessary (e.g., clavicular fracture). Intranasal fentanyl provides adequate and rapid analgesia comparable to that of IV morphine. 45,46  INTRANASAL KETAMINE Intranasal dosing for subdissociative ketamine is 0.5 to 1 milligram/kg. Similar to intranasal fentanyl, intranasal ketamine shares the advantages of early and rapid pain management for children who lack vascular access but is longer lasting (60 minutes for intranasal ketamine vs. 30 minutes for intranasal fentanyl). pain Visual Analog Scale (VAS) for pain severity measurement (not to scale) Most pain FIGURE 115-5. Visual Analog Scale. Tintinalli_Sec12_p0669-0996.indd 725 8/2/19 7:50 PM

management for children who lack vascular access but is longer lasting (60 minutes for intranasal ketamine vs. 30 minutes for intranasal fentanyl). pain Visual Analog Scale (VAS) for pain severity measurement (not to scale) Most pain FIGURE 115-5. Visual Analog Scale. Tintinalli_Sec12_p0669-0996.indd 725 8/2/19 7:50 PM 726 SECTION 12: Pediatrics TABLE 115-2 Analgesics for Acute ED Pain Management in Children Route Class Agent Dose Comments PO Nonopioid analgesic Acetaminophen 15 milligrams/kg Less effective than ibuprofen; may be combined with ibuprofen NSAID Ibuprofen 10 milligrams/kg Use singly or in combination with acetaminophen Ketorolac Not applicable Not approved for children Opioid Morphine Not recommended Not better than ibuprofen alone; greater side effects Oxycodone Not better than ibuprofen alone; greater side effects Hydrocodone Not recommended Contraindicated <6 y old Codeine Not recommended Contraindicated <12 y old Tramadol   Contraindicated <12 y old Intranasal Opioid Fentanyl 1.5–2 micrograms/kg (maximum, 100 milligrams) Faster and better than IV morphine; duration 30 min Other Ketamine 0.5–1.0 milligram/kg Analgesic dose (subdissociative); duration 60 min Parenteral NSAID Ketorolac 0.5 milligram/kg (maximum, 30 milligrams) For use in patients ≥24 mo old Opioid

ld Intranasal Opioid Fentanyl 1.5–2 micrograms/kg (maximum, 100 milligrams) Faster and better than IV morphine; duration 30 min Other Ketamine 0.5–1.0 milligram/kg Analgesic dose (subdissociative); duration 60 min Parenteral NSAID Ketorolac 0.5 milligram/kg (maximum, 30 milligrams) For use in patients ≥24 mo old Opioid Morphine 0.05–0.1 milligram/kg (maximum, 10 milligrams) Histamine release/pruritus; seizures in neonates; nausea; hypotension Hydromorphone 0.01–0.02 milligram/kg (maximum, 2 milligrams/dose) Nausea; pruritus Fentanyl 1–2 micrograms/kg (maximum, 100 micrograms/dose) Bradycardia; respiratory depression (outlasts analgesic effect); chest wall rigidity in young infants (increased risk with larger dose, rapid push) Other Ketamine 0.1–0.4 milligram/kg Analgesic (subdissociative) dose  IV NONSTEROIDAL ANTI-INFLAMMATORY AGENTS IV ketorolac is approved by the U.S. Food and Drug Administration for use in children as young as 24 months of age. Oral ketorolac is not more effective than ibuprofen or other NSAIDs, and oral ketorolac is not approved by the U.S. Food and Drug Administration for use in children.  IV SUBDISSOCIATIVE KETAMINE Ketamine is a noncompetitive N-methyl-d-aspartate and glutamate receptor antagonist that provides analgesia by decreasing central sensitization and pain memory.48 Subdissociative ketamine appears to have the same analgesic efficacy as intranasal fentanyl or IV morphine in early studies for fracture pain in the ED. 47,49,50  IV OPIOIDS For children with moderate to severe pain and established vascular access, IV opioids offer a rapid and effective pain management strategy. Children require more opioids proportionate to their weight than adults. The specific choice of parenteral opioids is determined by the individual characteristics of the drug, the clinical indication, and the patient’s prior experience with opioids. The initial IV dose of morphine is 0.05 to 0.1 milligram/kg (maximum, 10 milligrams per dose) and can be repeated at 10- to 15-minute intervals until adequate analgesia is accomplished. Once an adequate dose is established, it can be redosed every 2 to 4 hours, or more frequently if needed. Fentanyl is shorter acting, is associated with less histamine release than the nonsynthetic opioids, and has a relatively short duration of action. It can be dosed at 1 to 2 micrograms/kg (maximum, 100 micro grams per dose) for IV use. If fentanyl is given as a rapid IV bolus or in high doses to infants, it can cause “rigid chest phenomenon, ” which may require emergency reversal with naloxone or neuromuscular blockade. Hydromorphone has a much higher potency than morphine and may be useful for ongoing pain in children (e.g., sickle cell pain crisis). PAIN MANAGEMENT AFTER DISCHARGE Discharge teaching regarding pain assessment and management at home should be a standard part of emergency care. Without clear guidance, families risk inadequate pain management for the child, slower return to typical activities, and return visits for inadequately treated pain. Ibuprofen is the first-line agent for analgesia at home and can be combined or alternated with acetaminophen. Oral opioids including codeine, morphine, and oxycodone do not appear to offer advantage over ibuprofen alone and are associated with greater risk of side effects. 51,52  PROCEDURAL PAIN When painful procedures are unavoidable, use physical, psychological, and pharmacologic interventions to minimize pain. Advise parents to avoid false reassurances, such as “It won’t hurt” or “It’s over, ” because one cannot always reliably predict the end of the procedure or the effective ness of the analgesia that has been provided.

ocedures are unavoidable, use physical, psychological, and pharmacologic interventions to minimize pain. Advise parents to avoid false reassurances, such as “It won’t hurt” or “It’s over, ” because one cannot always reliably predict the end of the procedure or the effective ness of the analgesia that has been provided. Commonly performed ED procedures, such as IV cannulation, venipuncture, lumbar punctures, and urethral catheterizations, can be associated with significant pain and distress for children. 53,54 Children report needle-related pain as one of the worst things they experi ence while in hospital. 55 Undertreated pain has short- and long-term negative consequences for children and their families. In addition to causing acute discomfort, inadequate pain management may lead to increased perceived pain during future medical encounters, increased fear of medical procedures, and over- or underuse of future medical care. Thus, addressing the pain and distress associated with common ED procedures for children should be a standard part of practice (Table 115-3). When treating a laceration, when possible, tissue adhesives (e.g., Dermabond ® , Glu-Stitch® ) are preferred over sutures for all ages, as long as the laceration is not close to the eyes or over an area of tension. 56 If sutures are required, select absorbable sutures for areas of low tension (i.e., not joints) to avoid the retraumatization that some children experience with suture removal. Children over the developmental age of 4 years generally benefit from simple information regarding what to expect during a medical procedure. They can be told the steps of a procedure, what it might feel like (e.g., cold, wet), and even see what medical supplies will be used. Parents also require preparation regarding what to expect, how they can help with positioning and distraction, and how best to support their child. Tintinalli_Sec12_p0669-0996.indd 726 8/2/19 7:50 PM CHAPTER 115: Pain Management and Procedural Sedation for Infants and Children 727 TABLE 115-3 Analgesics for Needle-Based Procedures in Children Route Agent Administration/Dose Comments PO Sucrose 2 mL of 24% sucrose PO by syringe Birth to 12 mo old Intact skin

Commonly performed ED procedures, such as IV cannulation, venipuncture, lumbar punctures, and urethral catheterizations, can be associated with significant pain and distress for children. 53,54 Children report needle-related pain as one of the worst things they experi ence while in hospital. 55 Undertreated pain has short- and long-term negative consequences for children and their families. In addition to causing acute discomfort, inadequate pain management may lead to increased perceived pain during future medical encounters, increased fear of medical procedures, and over- or underuse of future medical care. Thus, addressing the pain and distress associated with common ED procedures for children should be a standard part of practice (Table 115-3). When treating a laceration, when possible, tissue adhesives (e.g., Dermabond ® , Glu-Stitch® ) are preferred over sutures for all ages, as long as the laceration is not close to the eyes or over an area of tension. 56 If sutures are required, select absorbable sutures for areas of low tension (i.e., not joints) to avoid the retraumatization that some children experience with suture removal. Children over the developmental age of 4 years generally benefit from simple information regarding what to expect during a medical procedure. They can be told the steps of a procedure, what it might feel like (e.g., cold, wet), and even see what medical supplies will be used. Parents also require preparation regarding what to expect, how they can help with positioning and distraction, and how best to support their child. Tintinalli_Sec12_p0669-0996.indd 726 8/2/19 7:50 PM CHAPTER 115: Pain Management and Procedural Sedation for Infants and Children 727 TABLE 115-3 Analgesics for Needle-Based Procedures in Children Route Agent Administration/Dose Comments PO Sucrose 2 mL of 24% sucrose PO by syringe Birth to 12 mo old Intact skin 4% amethocaine Cover procedural area and apply occlusive dressing Onset 30–45 minutes 4% liposomal lidocaine Cover procedural area and apply occlusive dressing Onset 30 minutes EMLA®  (2.5% prilocaine and 2.5% lidocaine) Cover procedural area and apply occlusive dressing Onset 60 min; best relief in 2–3 h Needle-free injection (e.g., J-tip® ) Prefilled device Pressure-driven transdermal lidocaine Open wounds LET®  (lidocaine 4%, epinephrine 0.1%, tetracaine 0.5%) 0.2 mL/kg Apply half into wound and half around wound edges Can be applied to end-organ tissues; onset 30–45 min; contraindicated <3 mo of age Local or regional injection

injection (e.g., J-tip® ) Prefilled device Pressure-driven transdermal lidocaine Open wounds LET®  (lidocaine 4%, epinephrine 0.1%, tetracaine 0.5%) 0.2 mL/kg Apply half into wound and half around wound edges Can be applied to end-organ tissues; onset 30–45 min; contraindicated <3 mo of age Local or regional injection Lidocaine 1% or 2% with or without epinephrine Maximum dose, 4 milligrams/kg (without epinephrine) Warm to room temperature; inject slowly with small-gauge needle; consider buffering with sodium bicarbonate (1:9) Bupivacaine 0.25% without epinephrine Maximum dose, 1.5 milligrams/kg Slower onset, longer duration than lidocaine; may be mixed with lidocaine for local or regional infiltration ORAL SUCROSE FOR INFANTS Oral sucrose is thought to work by activating endogenous opioids through taste receptors. 58 It reduces heart rate and time crying. It works best for infants <1 month of age, including premature babies, and up to 12 months of age. Give orally by a syringe (2 mL of a 24% sucrose solution or dilute dextrose 50% in water with equal parts of sterile water to make dextrose 25% in water) starting 2 minutes prior to the painful procedure. Sucrose solution comes in a variety of commercially available formulations (e.g., Sweet-Ease ® , Toot-Sweet® ). TOPICAL ANESTHETICS FOR INTACT SKIN Two commercially available fast-acting products are Ametopø (4% amethocaine) and LMX® (4% liposomal lidocaine). Both are fat-soluble creams that anesthetize the skin. Such agents are liposomal encapsu lated, which prevents entry into the circulation and acts as epidermal depots for prolonged drug release. The time to maximal effect is 30 minutes, and effect persists for about 30 minutes after cream removal. We recommend fast-acting topical anesthetic creams over EMLA ® (eutectic mixture of 2.5% prilocaine and 2.5% lidocaine).59-61 Nurse-initiated protocols can help avoid any time delays for vascular access. Another option for topical anesthesia prior to procedures such as venipuncture and lumbar puncture is the use of a needle-free injection system. The major advantage is that it is nearly instantaneous. 62-64 Needle-free injection systems deliver lidocaine into the dermis using a self-contained high-pressure delivery system such as a carbon dioxide gas cartridge. The J-tip ® (National Medical Products, Irvine, CA) is currently the most widely used needle-free injection system for local anesthesia.65 TOPICAL ANESTHETICS FOR OPEN WOUNDS LETø (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic mixture, often available in gel form, for open wounds and is safe and effective for almost all laceration repairs in children. Consider use before wound cleaning and exam, prior to suturing, and also for tissue adhesive application. 66 It can be applied to fingers, toes, lips, and other end-organ tissues despite the vasoconstrictive effects of the epinephrine. LET® is most effective for wounds that are not deeper than the subcutaneous tissues. When using LET, apply half into the wound and half on a saturated piece of sterile cotton (rather than gauze) at a maximum dose of 0.2 mL/kg. Then cover with an occlusive dressing (e.g., Tegaderm ® ). The adequacy of anesthesia from LET is highly dependent on proper application technique. Leave LET in place for at least 30 to 45 minutes for satisfactory wound anesthesia, with longer times (up to 45 minutes or more) generally leading to more complete anesthesia. Blanching of the skin from the vasoconstriction effects of epinephrine is a good sign that topical anesthesia has been achieved. LET is contraindicated in patients <3 months old and over inner mucosal surfaces. LOCAL ANESTHETIC INJECTION For anesthesia into deeper tissues, inject lidocaine.

to more complete anesthesia. Blanching of the skin from the vasoconstriction effects of epinephrine is a good sign that topical anesthesia has been achieved. LET is contraindicated in patients <3 months old and over inner mucosal surfaces. LOCAL ANESTHETIC INJECTION For anesthesia into deeper tissues, inject lidocaine. Slow injection with a small-gauge needle (e.g., 27 or 30 gauge) decreases discomfort. The addition of 1 mL of 8.4% sodium bicarbonate to 9 mL of 1% or 2% lidocaine buffers the acidity of the lidocaine and further reduces the pain of injection. Sodium bicarbonate must be added immediately before use or precipitation of the solution may result. Warming the injectable lidocaine to room temperature by rubbing the vial between your hands prior to drawing up the medication can help decrease the sting associ ated with lidocaine infiltration. The maximum dose of injected lidocaine without epinephrine is 4 milligrams/kg. When possible, consider regional nerve blocks (see Chapter 36, “Local and Regional Anesthesia”). The onset of action of bupivacaine is slightly longer than that of lidocaine, but it provides much longer lasting anesthesia. Combining bupivacaine with lidocaine can provide longer lasting, effective local anesthesia both during a pro cedure and afterward. Make sure the doses for injection are carefully calculated. ANXIOLYSIS FOR MINOR PROCEDURES In the ED, midazolam is almost universally preferred over other agents in this class because of its rapid onset and short duration of action. Benzodiazepines are not analgesic and should be combined with analgesics if a procedure is painful. Midazolam can cause paradoxical agitation, particularly at lower doses, and can cause respiratory depression and hypotension in high doses, particularly in hypovolemic patients. Fentanyl can also be given by the intranasal route for anxiolysis (Table 115-4). The main advantage of intranasal administration is a more rapid onset of action than the oral route, higher blood levels (by avoiding first-pass effects of the GI system), and no need for IV placement. Highconcentration solutions must be used because the maximum volume that can be delivered to each nostril is limited to approximately 0.3 to 0.5 mL at a time. Because the medication particles must be within a specific size range (approximately 10 to 50 microns) to be absorbed by the nasal mucosa, commercially available (and relatively inexpensive) mucosal atomizer devices are recommended for intranasal delivery of these medications. Nitrous oxide has anxiolytic properties in addition to amnestic and analgesic effects and is an alternative to midazolam for children with needle phobia or procedural anxiety (discussed further below under “Procedural Sedation” and in Table 115-4). Tintinalli_Sec12_p0669-0996.indd 727 8/2/19 7:50 PM

these medications. Nitrous oxide has anxiolytic properties in addition to amnestic and analgesic effects and is an alternative to midazolam for children with needle phobia or procedural anxiety (discussed further below under “Procedural Sedation” and in Table 115-4). Tintinalli_Sec12_p0669-0996.indd 727 8/2/19 7:50 PM 728 SECTION 12: Pediatrics  PROCEDURAL SEDATION ASSESSING THE PATIENT: THE PRESEDATION CHECKLIST Once the need to perform procedural sedation has been identified, perform a thorough medical evaluation to mitigate the risk of adverse events during and after sedation. Specific situations that may commonly arise include emergence agitation in children with active psychosis following ketamine sedation; laryngospasm in children with asthma and concomitant upper respiratory tract infection; cervical spine instability in children with trisomy 21; and difficult airway visualization in chil dren with Pierre Robin sequence. The following represents a compre hensive checklist incorporating recommendations from the American College of Emergency Physicians Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department 67 and the American Academy of Pediatrics Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures 68: 1. Physical status evaluation based on the American Society of Anes thesiologists (ASA) classification system (see Table 37-4, American Society of Anesthesiologists Classification System, in Chapter 37, “Procedural Sedation Analgesia in Adults”). In general, procedural sedation and analgesia for children in the ED should be limited to American Society of Anesthesiologists class I or II. For children in American Society of Anesthesiologists class III or IV or with ana tomic airway or cervical spine anomalies, consult with the appropri ate subspecialist(s) or anesthethiologist. 2. Obtain informed consent according to jurisdiction and institutional requirements. 3. Obtain a comprehensive health evaluation to document baseline status and determine if there are specific health conditions that require additional consultation or considerations in terms of drug selection or dosing. This includes age, sex, weight, allergies, current medications, and relevant personal or family comorbidities (renal, cardiac, or pulmonary conditions; seizures; neuromuscular diseases; con genital anomalies; obstructive sleep apnea; loose teeth; cervical spine anomalies; pregnancy; prematurity; previous sedation or anesthesia with specific inquiries regarding drug hypersensitivity; personal and family history of malignant hyperthermia; pseudocholinesterase deficiency; and complications). 4. Consider NPO status in the context of the urgency of the procedure and other risk factors that may increase the risk for vomiting and aspiration (see later in this chapter). 5. Assess the airway patency using the Mallampati grading scale to predict the technical ease of endotracheal intubation (see Figure 29A-5 in Chapter 29A, “Tracheal Intubation”), and assess tonsillar hyper trophy, mouth opening, lingual anomalies, mandibular anomalies, vital signs (heart rate, blood pressure, temperature, respiratory rate, oxygen saturation), and cervical spine mobility. 6.

t the technical ease of endotracheal intubation (see Figure 29A-5 in Chapter 29A, “Tracheal Intubation”), and assess tonsillar hyper trophy, mouth opening, lingual anomalies, mandibular anomalies, vital signs (heart rate, blood pressure, temperature, respiratory rate, oxygen saturation), and cervical spine mobility. 6. Ensure equipment is available, functional, and appropriately sized for the child using the acronym SOAPME: Suction (appropriate suction catheter and apparatus); Oxygen (supply is adequate and flowing); Airway equipment (bag-valve mask, laryngeal mask airway, oral and nasal airways, laryngoscope handle and blades); Pharmacologic agents (dissociative, anxiolytic, analgesic, and reversal agents) and Personnel as required by the institution (respiratory therapist, bedside nurse, etc.); Monitors (pulse oximeter, end-tidal carbon dioxide, noninvasive blood pressure, ECG leads); special Equipment (medicines or equipment for specific cases). NPO STATUS It is now widely held that there exists no correlation between fasting status and the risk of aspiration.69 The Pediatric Sedation Research Consortium documented only a single aspiration event in 30,037 children who underwent procedural sedation outside the operating room, and the event occurred in a child who fasted for >8 hours. 70 Current recommendations by the American College of Emergency Physicians Clinical Policy: Procedural Sedation and Analgesia in the Emergency Depart ment indicate that procedural sedation should not be delayed based on fasting time (Level B recommendations). 67 Although vomiting or aspi ration during procedural sedation performed in the ED is rare, 71 other societal guidelines outside emergency medicine recommend a 2-hour fast for clear liquids, 4 hours for breast milk, and 6 hours for solid food. Nonemergency guidelines are based on data from the anesthesia litera ture, in which the risk of aspiration is likely increased by endotracheal intubation and extubation, as well as greater depth of sedation. MONITORING DURING SEDATION Children should be monitored by qualified personnel for the entire duration of sedation until baseline presedation mental status has been attained. Unlike adults, children are at risk of unintentionally moving from the desired level of sedation to a deeper level of sedation, 73 and personnel with sufficient airway management skills should be in attendance. American Academy of Pediatrics clinical policy states that the individual should be certified in Pediatric Advanced Life Support and be skilled in “the ability to rescue a child with apnea, laryngospasm, and/or airway obstruction including the ability to open the airway, suction secretions, provide CPAP [continuous positive airway pressure], and perform suc cessful bag-valve-mask ventilation. ” 68 The number and type of person nel mandated to be present during procedural sedation in children are institution specific. Ideally, two healthcare personnel should be present: a physician, respiratory therapist, or their designee performing the sedation, and a physician or their designee performing the procedure. The American College of Emergency Physicians clinical policy states that a nurse or other “qualified individual” should continuously monitor the patient along with the “provider performing the procedure” (Level C recommendation). 67 However, the literature does not provide clear guidance on the number and type of personnel needed in a busy ED with time and staffing constraints and where two simultaneous providers are present TABLE 115-4 Medications for Pediatric Anxiolysis in the ED Drug Concentration Route Dose Onset Duration Side Effects/Warnings Midazolam

e literature does not provide clear guidance on the number and type of personnel needed in a busy ED with time and staffing constraints and where two simultaneous providers are present TABLE 115-4 Medications for Pediatric Anxiolysis in the ED Drug Concentration Route Dose Onset Duration Side Effects/Warnings Midazolam 5 milligrams/mL Oral Intranasal 0.5 milligram/kg 0.3–0.5 milligram/kg; maxi mum, 10 milligrams/dose 0.05–0.1 milligram/kg 30 min 5–15 min 0.5–2 h 0.5–2 h Excitation/paradoxical reaction Somnolence Nasal irritation Bitter taste Nitrous Oxide 1.   50% N2O + 50% 02 fixed mixture (Entonox® ) 2. Titratable blend of N2O and O2 to a maximum of 70% N2O Inhaled (selfadministered through mouthpiece or facemask or nasal hood) Maximum concentration N 2O of 70% (minimum O2 concentration 30%) 30 seconds (peak effect 3–5 minutes) Effects decrease 70% within 3 minutes of discontinuation Nausea Dysphoria Contraindicated with bowel obstruction, pneumothorax, increased intracranial pressure Teratogenic Tintinalli_Sec12_p0669-0996.indd 728 8/2/19 7:50 PM

um concentration N 2O of 70% (minimum O2 concentration 30%) 30 seconds (peak effect 3–5 minutes) Effects decrease 70% within 3 minutes of discontinuation Nausea Dysphoria Contraindicated with bowel obstruction, pneumothorax, increased intracranial pressure Teratogenic Tintinalli_Sec12_p0669-0996.indd 728 8/2/19 7:50 PM CHAPTER 115: Pain Management and Procedural Sedation for Infants and Children 729 or possible. In fact, several lines of evidence suggest that the frequency of serious complications (apnea, airway obstruction, hypotension, hypoxia) is similar whether one physician performed both the sedation and procedure or the tasks were divided among two physicians. 74,75 In addition to clinical assessment, monitor vital signs including heart rate, respiratory rate, blood pressure, oxygen saturation using a pulse oximeter, ECG recording, and capnography. The use of prophylactic supplemental oxygen is currently recommended for sedation with propofol and optional for other agents. POSTSEDATION MONITORING AND RECOVERY After the procedure, monitor in the ED until recovery is complete and the child has resumed the presedation level of consciousness. Monitor ing should include obtaining vital signs at regular intervals (every 5 minutes while sedated and less frequently once awake) and continuous display of heart rate and oxygen saturation if not fully alert. 68 Imme diately following the procedure, with the cessation of painful stimuli, the patient may still be under the effect of the dissociative or sedative agent. Consequently, there is an increased risk of respiratory depression during this time. For this reason, patients should be monitored in a recovery area that is equipped with a suction device, the ability to deliver >90% oxygen, positive-pressure ventilation using a bag-valve mask, and rescue equipment for airway and ventilatory support. 68 If sedation was performed using ketamine, even with the preadministration of ondansetron, nausea and vomiting may occur and should be anticipated. Patients should be allowed to recover in a quiet environment with minimal visual and auditory stimuli, and caregivers should be encouraged to be at the bedside. Discharge criteria include the following: vital signs within normal age-related parameters, including blood pressure and pulse oximetry; return to presedation level of consciousness (if sleeping, the patient should be easily arousable); ability to sit unaided (within the context of developmental capabilities); and ability to tolerate oral fluids (protect airway). Parents should also be seated with the child whenever possible in the back seat of a vehicle after discharge. Parents should review and understand written postsedation discharge instructions, which advise them to closely observe their child for abnormal somnolence and to restrict activities that require coordination until all medication effects have worn off. Parents should also be warned that delayed sequelae of sedation, including vivid dreams, sleep disturbance, and behavioral dysregulation, may occur up to 24 hours after sedation. Advise parents to protect the child from falls due to incoordination for several hours after discharge. Again, whenever possible, for the child who has received sedation, parents should accompany the child in the back seat of the vehicle after discharge. SELECTING AGENTS FOR SEDATION Benzodiazepines, ketamine alone, ketamine with propofol, etomidate, propofol, and nitrous oxide are all well-studied agents for procedural sedation and analgesia in children. 71 Dosing regimens for each can be found in Table 115-5. Although several agents can be used to effectively facilitate procedural sedation, the choice of agent(s) and the dose should be determined, at least in part, by the goals of sedation.

are all well-studied agents for procedural sedation and analgesia in children. 71 Dosing regimens for each can be found in Table 115-5. Although several agents can be used to effectively facilitate procedural sedation, the choice of agent(s) and the dose should be determined, at least in part, by the goals of sedation. For nonpainful procedures, the goal is often anxiolysis alone, and benzodiazepines in combination with psychological and physical approaches may be effective in some patients. For minor painful procedures such as laceration repair, the goal is both anxiolysis and moderate analgesia. Intranasal fentanyl or dexmedetomidine, subdissociative dose ketamine, and nitrous oxide are all viable options. For major painful procedures such as orthopedic reduction, the goal is dissociative sedation with amnesia and analgesia. Importantly, procedural sedation may not be necessary in a cooperative patient and a clinician skilled in regional anesthesia.  KETAMINE Ketamine produces a dissociative sedation characterized by a rapidonset and potent dissociation, amnesia, and analgesia, while preserving pharyngeal-laryngeal reflexes, respiratory drive, cardiopulmonary sta bility, and skeletal muscle tone. 71,76 Adequate sedation for a 20- to 30-minute procedure can be achieved with a single IV loading dose, and the drug is safe in children as young as 3 months of age. 77 These properties make it an ideal agent for painful procedures such as fracture reduction and abscess drainage. Preprocedural use of ondansetron can reduce the incidence of vomiting in children, 71,78 but there may be less benefit in children under 5 years of age and adolescents 77 because the baseline risk of vomiting with ketamine is lower in these age groups. Ketamine does exhibit a dose-response relationship with respect to adverse effects. Although higher doses are not associated with an increased risk of serious adverse events or interventions in response to serious adverse events, higher doses are associated with a greater risk of oxygen desatu ration and vomiting. 71 Recovery agitation is also common following sedation with ketamine and is not believed to be age related. 77 Unlike in adults,79,80 pediatric-specific studies have reported that coadministra tion of midazolam does not reduce the risk of emergence agitation. 77 Benzodiazepines such as midazolam should be reserved for reducing preprocedural anxiety and treatment of emergence agitation. A subdissociative dose of ketamine (0.3 milligram/kg IV) has anal gesic and amnestic effects despite the lack of a dissociative state. Sub dissociative doses are not sufficient for more painful procedures such as fracture reduction and have a greater risk of recovery agitation. Ketamine’s anesthetic effects manifest at a dosing threshold of approximately 1.0 to 1.5 milligrams/kg IV , and additional doses do not produce enhanced sedation or hemodynamic compromise. 81 The only value of additional ketamine is to prolong the dissociative state for extended procedures. 82 Ketamine may also be administered IM at a dose of 4 to 5 milligrams/kg. However, IM administration is painful, is unpredictable in response, may cause more vomiting, and has a prolonged recovery time compared with the IV route and should therefore be reserved for children in whom IV access is difficult. 76 Opioids are commonly given to children before procedural sedation with ketamine (e.g., prior to imaging), and preprocedural analgesia is important. However, recent evidence demonstrates that preprocedural opioids increase the risk of all adverse events except serious adverse events, regardless of the medica tion used for sedation.

commonly given to children before procedural sedation with ketamine (e.g., prior to imaging), and preprocedural analgesia is important. However, recent evidence demonstrates that preprocedural opioids increase the risk of all adverse events except serious adverse events, regardless of the medica tion used for sedation. The combination regimen of ketamine and propofol (“ketofol”) has a shorter sedation time (3 minutes) 83 and fewer concomitant analgesic requirements.84 As a result, this combination has gained popularity over the past decade. However, experts have yet to support the regular use of ketofol because objective benefits have not been demonstrated. 85 In fact, for procedural sedation in children, there is stronger evidence for the safe administration of ketamine or propofol as sole agents (Level A recommendation) than for a combination of ketamine and propofol (Level B recommendation). 67 Moreover, a recent multicenter Canadian surveillance study of >6000 children found that the use of ketamine alone was associated with the lowest risk of a serious adverse event or needed intervention. The combinations of ketamine with propofol and ketamine with fentanyl had the highest risks of oxygen desaturation and the need for significant interventions in response to a serious adverse event. Due to ketamine’s tendency to enhance rather than depress airway reflexes, an important consideration surrounding its use in the ED is the risk of laryngospasm. In children, the risk of laryngospasm is uncom mon (0.3%), and this complication often quickly responds to assisted ventilation and oxygen, without the use of therapeutic agents. 86 Case reports and anecdotal evidence highlight the risk of airway obstruction, laryngospasm, and apnea in infants younger than 3 months, likely due more to age-specific vulnerability of the young infant’s airway anatomy and reactivity. As a result, age <3 months is a notable absolute contraindication to the use of ketamine. 82 Other groups that may be at increased risk of laryngospasm include children with asthma or concomitant upper respiratory tract infection. However, guidelines do not support withholding ketamine in these situations. 82 Another absolute contraindication is schizophrenia due to a risk of exacerbating psychosis.82  MIDAZOLAM Midazolam is the most commonly used benzodiazepine for procedural sedation or anxiolysis in children. 76 However, there is no high-quality Tintinalli_Sec12_p0669-0996.indd 729 8/2/19 7:50 PM

in these situations. 82 Another absolute contraindication is schizophrenia due to a risk of exacerbating psychosis.82  MIDAZOLAM Midazolam is the most commonly used benzodiazepine for procedural sedation or anxiolysis in children. 76 However, there is no high-quality Tintinalli_Sec12_p0669-0996.indd 729 8/2/19 7:50 PM TABLE 115-5 Medications for Procedural Sedation Class Drug Route Dose Onset Duration Advantages Disadvantages Examples Comments Nonpainful Procedures Anxiolytic Midazolam PO, PR, IV, IM, IN PO/PR 0.5 milligram/kg IV/IM 0.05–0.1 milligram/kg IN 0.3–0.5 milligram/kg PO/PR 20–30 min IV 3–5 min IM 10–20 min IN 5–10 min 1–4 h Flexible route of administration No analgesia, paradoxical reaction CT scan; ultrasound; echocardiography Acidic, nasal administration stings, may cause increased secretions; oral/rectal slow onset, less predictable Sedative Pentobarbital PO 3–5 milligrams/kg 30 min Variable Relatively safe in oral doses No analgesia CT scan Variable efficacy; long recovery times Minor Painful Procedures Dissociative Nitrous oxide Inhaled Titrate to effect (30%–70%) Minutes Minutes Self-dosing Not readily available Laceration repair; LP; dental procedures Scavenger system recommended Analgesic Fentanyl IN 1.5 micrograms/kg (maximum, 0.5 mL per nare) 10 min 20 min Little to no adverse effects Short lived Laceration repair; suspected clavicle fracture Equivalent to IV morphine Analgesic and mild sedative Subdissociative dose ketamine IV/IN 0.3 milligram/kg IV 1 milligram/kg IN Variable 60 min Few adverse effects   Laceration repair; abscess drainage Paucity of pediatric data Hypnotic/sedative Dexmedetomidine IN 0.5–2 micrograms/kg 25 min 85 min No respiratory/hemodynamic compromise Long time to onset Laceration repair; LP; abscess drainage Paucity of data for ED procedures Major Painful Procedures Hypnotic/sedative Propofol IV 1–2 milligrams/kg, followed by 0.5 milligram/kg; repeat doses as needed Seconds Minutes Rapid onset and short duration, motionlessness, muscle relaxant No analgesia, respiratory and cardiovascular depressant CT scan, LP with topical analgesic, laceration repair, reduction of dislocation Nonanalgesic, increased requirement for younger patients, painful injection Etomidate IV 0.2–0.3 milligram/kg Seconds Minutes Rapid onset, short duration No analgesia, myoclonus, respiratory depressant CT scan, short procedures requiring motionlessness Avoid in patients with increased tone (e.g., CP) due to myoclonic jerks, painful injection Dissociative Ketamine IV, IM IV 1–1.5 milligrams/kg IM 4–5 milligrams/kg IV 1–2 min IM 3–5 min IV 15 min IM 30–45 min Analgesic, anesthetic, motionlessness, respiratory and cardiovascular stimulant, bronchodilator Increased intraocular pressure, intracranial pressure, salivation; emetogenic; laryngospasm Painful procedures requiring motionlessness (complex lacerations, fracture reductions, I&D), no reversal agent Consider pretreatment with ondansetron; atropine and midazolam coadministration unnecessary Propofol + ketamine IV Propofol 1 milligram/kg, ketamine 0.5 milligram/kg 1 min Propofol (minutes); ketamine 15–45 min Decreased dosing for both agents, complementary side effects (lessens respiratory and cardiovascular depression, emesis) Increased risk of serious adverse events such as oxygen desaturation (compared to ketamine alone) Fracture reduction, I&D, complex laceration Recent evidence suggests coadministration is associated with greater risk of adverse events Abbreviations: CP = cerebral palsy; I&D = incision and drainage; IN = intranasally. Tintinalli_Sec12_p0669-0996.indd 730 8/2/19 7:50 PM