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Procedural Sedation and Analgesia in Children Baruch S. Krauss, M.D., Benjamin A. Krauss, and Steven M. Green, M.D. The following text summarizes information provided in the video. Overview

Procedural sedation and analgesia involve the use of one or more sedative and analgesic agents to relieve pain and anxiety and to control motor activity in patients undergoing diagnostic and therapeutic procedures. We have the capability to safely and effectively relieve children of the pain and distress associated with medical procedures. Accordingly, procedural sedation and analgesia have become the standard of care for children and are widely practiced worldwide by a diverse group of specialists in both inpatient and outpatient settings. As the multidisciplinary field of procedural sedation has evolved and matured, indications for the use of sedation have grown.1,2 The video shows the technique of procedural sedation and analgesia in children. This supplement reviews the information presented there, including indications, patient assessment, the use of sedative and analgesic drugs, potential adverse events, recovery, and discharge from the hospital.

From the Division of Emergency Medicine, Boston Children’s Hospital (Baruch Krauss), and the University of Massachusetts Boston (Benjamin Krauss) — both in Boston; and the Department of Emergency Medicine, Loma Linda University Medical Center, Loma Linda, CA (S.M.G.). Address reprint requests to Dr. Krauss, Division of Emergency Medicine, Boston Children’s Hospital, 300 Longwood Ave., Boston, MA 02115, or at baruch.krauss@ childrens.harvard.edu. N Engl J Med 2014;370:e23. DOI: 10.1056/NEJMvcm1108559 Copyright © 2014 Massachusetts Medical Society.

Indications

Procedural sedation is frequently used for both diagnostic and therapeutic procedures, whether urgent or elective. Typical indications include diagnostic imaging, fracture reduction or dislocation, wound care and repair of a laceration, incision and drainage of an abscess, lumbar puncture, bone marrow aspiration and biopsy, placement of a central venous catheter, and gastrointestinal endoscopy.2 Patient Assessment

Sedation is contraindicated or inadvisable when the risk of adverse events is high. Carefully evaluate each patient to assess his or her suitability for sedation. Obtain a directed history and perform a physical examination that will help you identify factors that may be relative or absolute contraindications to sedation, such as obesity, sleep apnea, allergies to medications, previous problems with sedation or anesthesia, the presence of a difficult or potentially difficult airway, and an active respiratory infection or respiratory disease.3,4 Risk assessment should include a general assessment of underlying health, such as the five-point Physical Status Classification System of the American Society of Anesthesiologists. Procedural sedation is often performed only in patients whose status is Class I (a normal, healthy patient) or Class II (a patient with mild systemic disease), except in urgent or special situations (Table 1). Assess and document the time at which the patient last ate or drank. For elective procedures, follow established fasting guidelines, such as those of the American Academy of Pediatrics. For urgent or emergency procedures, a risk–benefit assessment should be performed (Table 2).5,6 If during assessment you identify a child who is at high risk for adverse events during sedation, postpone the sedation, if possible, or consult an anesthesiologist. n engl j med 370;15 nejm.org april 10, 2014

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Table 1. Classification of Physical Status According to the American Society of Anesthesiologists. Class

Description

Examples

Suitability for Sedation

I

A normal, healthy patient

Unremarkable medical history

Excellent

II

A patient with mild systemic disease — no functional limitation

Mild asthma, controlled seizure disorder, anemia, controlled diabetes mellitus

Generally good

III

A patient with severe systemic disease — definite functional limitation

Moderate-to-severe asthma, poorly controlled seizure disorder, pneumonia, poorly con­trolled diabetes mellitus, moderate obesity

Poor; consider benefits relative to risks

IV

A patient with severe systemic disease that is a constant threat to life

Severe bronchopulmonary dysplasia; sepsis; advanced degree of pulmonary, cardiac, hepatic, renal, or endocrine insufficiency

Poor; benefits rarely outweigh risks

V

A moribund patient who is not expected to survive without the operation

Septic shock, severe trauma

Extremely poor

Table 2. Preprocedure Fasting Guidelines According to the American Academy of Pediatrics. Solid or Liquid Food

Duration of Fast

Clear liquids

2 hours

Breast milk

4 hours

Infant formula

6 hours

Solids

6 to 8 hours

After completing the presedation assessment, discuss the risks, benefits, and limitations of procedural sedation, as well as any alternatives, with the parent or guardian and with the patient, if capable. Then obtain appropriate consent or assent. Before the procedure, children may be distressed or in pain. Age-specific psychological techniques can help children control their anxiety. Many procedures can be performed without sedation or with minimal sedation if the child can cooperate. In selected circumstances, premedication may be warranted; for distress, oral or intranasal midazolam is a common choice, and for pain, oral oxycodone or intranasal fentanyl can be used. The use of a topical anesthetic to minimize procedural sensations is an essential component of procedural sedation in children. It is useful before placement of an intravenous catheter, lumbar puncture, and laceration repair. To ensure patient safety, perform sedation only when you have the necessary age-appropriate emergency equipment. This equipment would include a ventilation bag and mask, oxygen, and a suction device. Clinicians must have the requisite skills to effectively manage potential adverse events, such as respiratory depression or upper-airway obstruction. Either you or an immediately available colleague must be able to perform the maneuvers required for airway alignment, deliver positivepressure ventilation with a bag and mask effectively, and initiate any other rescue measures that may be needed. Resuscitation equipment and medications, including reversal agents, must be immediately available. Intravenous access is often unnecessary when the route of sedation is oral, intranasal, rectal, intramuscular, or inhalational. However, you must be able to establish access for intravenous administration, which is strongly preferred when sedation is deep or prolonged. Phases of Sedation

There are three phases of procedural sedation: presedation, sedation, and postsedation. Sedation is best understood as a continuum, ranging from lighter to deeper sedation and, finally, to general anesthesia. All sedating agents, with the exception of ketamine, fall into this category. For convenience, this continuum has been arbitrarily divided into a series of progressive stages. The sedation nomenclature most often used worldwide is also used here (Fig. 1). At the lightest end of the sedation continuum is minimal sedation, a drug-­ induced state during which patients respond normally to verbal commands. Although patients at this level of sedation may have drowsiness and impaired coor-

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procedur al sedation and analgesia in children

dination, normal ventilation is maintained. Minimal sedation of the patient may be adequate to allow brief minor procedures to be performed or to inhibit movement to the extent required to perform diagnostic imaging. The next level is moderate sedation, during which patients respond purposefully to verbal commands alone or when the commands are accompanied by light tactile stimulation. At this level of sedation, children can usually be expected to open their eyes or take a deep breath on command. It is expected that patients at this level of sedation will maintain a patent airway and adequate respirations without assistance. Moderate sedation is sufficient for motion control during diagnostic imaging and for many painful procedures in which local or topical anesthetic agents can be used (e.g., laceration repair). The third level of sedation is deep sedation, in which patients cannot be easily aroused but can respond purposefully after repeated or painful stimulation. Since children sedated to this level may not always maintain a patent airway and adequate respirations, they must be monitored closely. Deep sedation is often used for painful procedures for which local or topical anesthetic agents are not sufficient (e.g., fracture reduction or bone marrow aspiration). Deep sedation may also be indicated if complete motion control is essential during diagnostic imaging. When the bounds of deep sedation are exceeded, the patient has reached the state of general anesthesia. In this state, the patient is unresponsive to painful stimulation and is at high risk for airway obstruction and apnea. Immediate rescue measures may be indicated to support airway patency and ventilatory function until the patient returns to a lighter level of sedation. Patients will often move up and down the continuum during the course of a procedure. It is therefore critical to monitor patients continuously and to be prepared to rescue them from levels of sedation that are deeper than intended. Dissociative sedation does not fit into the continuum described in the video; this type of sedation occurs in patients who receive ketamine. In dissociative sedation, patients enter a cataleptic state in which there is functional dissociation of the higher cortical centers from outside stimuli. The typical response to other sedating agents is central nervous system depression, in which the patient is unresponsive to pain but almost always retains protective airway reflexes and spontaneous respirations.7 The monitoring of vital signs, including pulse oximetry, electrocardiography, and blood-pressure measurement, is an essential part of procedural sedation and enhances safety. Continuous pulse oximetry is mandatory for the detection of hypoxemia. Periodic measurement of blood pressure and continuous electrocardiography are typically used to verify hemodynamic stability. Serious adverse cardiovascular events are extremely rare in children who do not have underlying cardiovascular disease. Capnography is recommended, especially during deep sedation, because it provides the earliest possible advance warning of respiratory depression. Capnography depicts the carbon dioxide level during each breath as a waveform. Characteristic changes in the waveform combined with clinical observations can be used to quickly identify respiratory depression, apnea, and airway obstruction (Fig. 2).8 In general, vital signs should be measured at baseline, after drug administration, on completion of the procedure, during early recovery, and at completion of recovery before discharge. They should also be measured as indicated on the basis of individual condition and level of sedation. During deep sedation, vital signs are often recorded every 5 minutes. Patients are at highest risk for respiratory depression shortly after the administration of intravenous medications and when procedural stimuli are discontinued.

Minimal Sedation

Moderate Sedation

Deep Sedation

General Anesthesia

Figure 1. Sedation Continuum.

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Safe sedation requires a minimum of two experienced practitioners — typically, a physician to perform the procedure and a nurse to continuously monitor the patient and document vital signs. Depending on the anticipated level of sedation and on the practice setting (specialty type, procedure type, and location), two physicians may be strongly preferred — one to administer medications and monitor the patient, and the other to perform the procedure. Sedation may be performed with or without supplemental oxygen, and clinicians must carefully weigh the potential advantages and disadvantages of this B

A

B

Figure 2. Normal and Abnormal Capnograms. Panel A shows normal ventilation and 100% oxygen saturation, and Panel B shows impaired ventilation and 100% oxygen saturation.

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procedur al sedation and analgesia in children

adjunct. Administering supplemental oxygen before and during deep sedation has been shown to reduce the frequency of hypoxemia. However, such administration renders pulse oximetry ineffective as a means of early warning for respiratory depression. Thus, the use of capnography is strongly recommended if supplemental oxygen is used, since capnographic readings are not affected by the presence or absence of additional oxygen. Use of Sedative and Analgesic Drugs

The drugs used in procedural sedation and analgesia fall into five general classes: opioids for analgesia, sedatives for anxiety reduction and sedation, dissociative agents for analgesia and sedation, inhalational gases for mild analgesia and sedation, and opioid and benzodiazepine antagonists to reverse the effects of these agents, when necessary. Various agents can be administered through multiple routes — oral, intranasal, rectal, intramuscular, intravenous, and inhalational (Table 3).1,2 For procedures that are not painful (e.g., diagnostic imaging, in which the primary intent of sedation is motion control), options for medication include intravenous pentobarbital, intravenous fentanyl combined with intravenous midazolam, or intravenous propofol. For minimally painful procedures that require varying levels of motion control, such as minor laceration repair, drug options include oral or intranasal midazolam, intranasal fentanyl, nitrous oxide, intramuscular or intravenous ketamine, intravenous propofol, or intravenous fentanyl combined with intravenous midazolam. For painful procedures, such as fracture reduction or bone marrow aspiration, drug options include intravenous fentanyl combined with intravenous midazolam, intramuscular or intravenous ketamine, intravenous propofol combined with intravenous fentanyl, or intravenous propofol combined with intravenous ketamine (Table 4). (More specific information on the selection of drug regimens for sedation is beyond the scope of the video. Several sources are listed in the reference section of this supplement.) To administer medications for sedation safely and effectively, it is important to understand their basic pharmacokinetics. Knowledge of the time of onset, time of peak effect, and duration of effect for each drug allows safe administration, without any overlapping of peak effects when multiple agents are used and with less potential for oversedation. Many procedures will require repeat dosing to achieve and maintain the chosen sedation end point, particularly when the agents used are short-acting, such as propofol.

Table 3. Types and Examples of Drugs Used for Procedural Sedation and Analgesia. Opioid Oxycodone Morphine Fentanyl Sedative Midazolam Pentobarbital Etomidate Propofol Dissociative Agent Ketamine Inhalational Gas Nitrous oxide Antagonist Naloxone Flumazenil

Recovery and Discharge

After the procedure is completed, monitoring should be continued until the patient returns to the age-appropriate baseline state and meets local criteria for safe discharge. The child should be alert, should have stable vital signs, and should be able to talk and to sit unaided as appropriate for age. However, the child does not need to be able to walk unaided before discharge or to be able to drink fluids; fluid intake may induce vomiting if allowed too early, prolonging the recovery period. Standardized recovery scoring systems are widely used to objectively determine a safe time for discharge. The time to recovery of baseline state varies with the drugs used, but most patients can be discharged within 1 to 2 hours. The caregiver should be provided with discharge instructions that contain information about the appropriate diet, medications, and activity level for the child and about whom to contact if questions or problems arise within the 24 hours after sedation.

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procedur al sedation and analgesia in children

Table 4. Recommended Sedation Strategies for Various Procedures. Type of Procedure

Indication

Purpose

Sedation Strategy*

Nonpainful

Computed tomography, echocardiography, electro­ Motion control encephalography, magnetic resonance imaging, ultrasonography

Comfort alone; oral, intranasal, or intra­ venous midazolam; intravenous pento­ barbital; intravenous propofol; intra­ venous etomidate

Minimally painful

Dental procedures, flexible fiberoptic laryngoscopy, foreign-body removal (simple), intravenous cannulation, laceration repair (simple), lumbar puncture, ocular irrigation, phlebotomy, slitlamp examination

Anxiolysis, motion control, sedation

Comfort alone; topical anesthetic, local anesthetic, or both; oral, intranasal, or intra­venous midazolam; intranasal fentanyl; nitrous oxide; intramuscular or intravenous ketamine

Painful

Abscess incision and drainage, arthrocentesis, bone marrow aspiration, burn débridement, cardiac catheterization, cardioversion, central catheter placement, endoscopy, foreign body removal (complicated), fracture or dislocation reduction, hernia reduction, interventional ­radiology procedures, laceration repair (complex), paracentesis, paraphimosis reduction, sexual assault examination, thoracentesis, ­thoracostomy-tube placement

Amnesia, analgesia, Intramuscular or intravenous ketamine, anxiolysis, motion intravenous midazolam and fentanyl, control, sedation intravenous propofol and fentanyl; ­intravenous propofol and ketamine

* Drugs are listed in order of ascending potency, with the most potent listed last.

References 1. Krauss B, Green SM. Sedation and analgesia for procedures in children. N Engl J Med 2000;342:938-45. 2. Idem. Procedural sedation and analgesia in children. Lancet 2006;367:766-80. 3. Green SM, Krauss B. Pulmonary aspiration risk during emergency department procedural sedation — an examination of the role of fasting and sedation depth. Acad Emerg Med 2002;9:35-42. 4. Bhatt M, Kennedy RM, Osmond MH, et al. Consensus-based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med 2009; 53:426-35, e4. 5. Agrawal D, Manzi S, Gupta R, Krauss B. Preprocedural fasting state and adverse events in children undergoing procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med 2003;42:636-46. 6. Green SM, Roback MG, Miner JR, Burton JH, Krauss B. Fasting and emergency department procedural sedation and analgesia: a consensus-based clinical practice advisory. Ann Emerg Med 2007; 49:454-61. 7. Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med 2011;57:449-61. 8. Krauss B, Hess DR. Capnography for procedural sedation and analgesia in the emergency department. Ann Emerg Med 2007;50:172-81.

Summary

Pediatric procedural sedation and analgesia is a multidisciplinary technique that is used to manage procedural anxiety and pain. It is effective and generally safe when performed by appropriately trained practitioners. The ultimate goal of procedural sedation is to provide a painless, nontraumatic experience for children who are undergoing diagnostic or therapeutic procedures. Dr. Krauss reports receiving consulting fees from Oridion Medical and being named in four patents held by Boston Children’s Hospital — one patent related to respiratory analysis with capnography (U.S. patent 6,648,833), two patents related to a waveform interpreter for respiratory analysis (U.S. patents 6,997,880 and 6,428,483), and one patent related to an automated interpretive medical care system and methodology (U.S. patent 8,147,419). No other potential conflict of interest relevant to this article was reported. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Copyright © 2014 Massachusetts Medical Society.

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Videos in clinical medicine. Procedural sedation and analgesia in children.

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