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Pediatric Sedation & Analgesia: Methods to Enhance Safety

Cathie T. Jones, MD, FASA Boston, MA

INTRODUCTION

Pediatric procedural sedation & analgesia (PSA) has grown significantly in recent years and occurs in emergency
rooms, procedure suites, radiology, dental offices and non-operating room locations by providers with varying levels
of training and expertise. Children receive sedation for these interventions as they are often less able to tolerate some
procedures or imaging studies than adults.

The majority of pediatric patients who receive PSA are not cared for by anesthesiologists or CRNAs 1. Overall,
serious adverse events in PSA are rare when the sedation is provided by trained sedation teams1,2. A recent review
from the Pediatric Sedation Research Consortium (PSRC) reported a serious adverse event (SAE) rate at 1.78%,
with upper airway obstruction being the most common SAE2. Unfortunately, serious safety events, including
deaths, have occurred during sedation. These adverse outcomes were likely avoidable had standard safety measures
been used3.

Sedation guidelines are provided by the American Academy of Pediatrics (AAP), the American Academy of
Pediatric Dentistry (AAPD)4, and the American Society of Anesthesiologists (ASA)5 with the goal to minimize
adverse outcomes and increase safety for all patients.

This Refresher Course aims to help you incorporate safe strategies in your sedation practice, so that your pediatric
patients receive safe and effective sedation and analgesia. We will review the levels of sedation, discuss the
components of a successful sedation program, challenges in various off-site locations, some emerging medications
and non-pharmacologic distraction techniques.

LEVELS OF SEDATION AND MONITORED ANESTHESIA CARE

Sedation represents a continuum from wakefulness to general anesthesia 6. The most important goal is to keep the
patient safe during and after the procedure. Additional goals including behavioral modification, increased procedural
compliance, reduction of fear and anxiety, and management of discomfort and pain. There may be times when
maximizing amnesia and minimizing psychological trauma are also important 4. A patient can move from one level
of sedation to another, and the practitioner must be able to rescue a patient whose sedation becomes deeper than the
level intended7.

Traditional sedation definitions were written for adults and are dependent on the patient’s ability to respond verbally
or purposefully. The table below reflects a pediatric focus for assessment. Mild or moderate sedation is challenging
and often not successful in younger patients. Children under age 6 frequently need deep sedation for procedures 2,4.
In these circumstances, general anesthesia may be safer, faster and more cost-effective1.

TABLE 1: Target sedation level definitions4,7

Level of sedation Characteristics
Minimal (anxiolysis) Child is conscious but cognitive function and coordination may be impaired. Child can
respond to verbal commands. Cardiorespiratory responses are maintained.
Moderate Child is sleepy but responds purposefully to verbal commands or light tactile
(“conscious stimulation. Cardiorespiratory responses are maintained.
sedation”)

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Deep Consciousness is not maintained and the child cannot be easily aroused. A purposeful
response is elicited with repeated verbal or painful stimulation. Spontaneous ventilation
may require support. Cardiovascular responses may require minimal support.
General anesthesia An unconscious state where painful stimulation does not arouse the child. Respiratory
effort may be spontaneous but decreased in frequency or depth with apnea being
common. Cardiovascular responses may require support.

There can be confusion between Moderate Sedation (formerly called conscious sedation) and Monitored Anesthesia
Care (MAC). MAC includes the periprocedural anesthesia assessment, along with managing the patient’s actual or
anticipated physiologic derangements during the procedure. A two-provider model is mandatory if MAC is to be
provided7. In the “traditional” sedation model, the responsible physician may assume the dual role of performing the
procedure and supervising the sedation (implying a single-provider model)8.

COMPONENTS OF A SUCCESSFUL SEDATION PROGRAM – A SYSTEMATIC APPROACH

Structured sedation protocols, used by qualified providers, can improve patient safety. 9 The sedation program at
your hospital should include a sedation committee which oversees training, credentialing, and skill maintenance of
the providers performing sedation. Quality improvement processes and critical incident reviews should be in place
to evaluate, assess and improve processes1.

PRE-SEDATION ASSESSMENT

The pre-sedation assessment includes a medical assessment and a focused physical exam. It should include past
medical history, current comorbidities and surgical problems1,4. There should be a focus on respiratory (recent URI,
history of snoring, disordered sleep or sleep apnea), cardiac (congenital heart disease, arrhythmias), gastrointestinal
(delayed gastric emptying or severe gastroesophageal reflux disease), and systemic (genetic disorders, morbid
obesity, major endocrine disorders) issues. The personal and family history of sedation or anesthesia problems
including adverse reactions should be assessed as well as patient’s psychological and developmental status 4,10-12.

The physical exam should focus on airway abnormalities, including evaluation for possible airway obstruction
(tonsillar hypertrophy, macroglossia), difficult intubation (micro or retrognathia, limitations in mouth opening) or
other craniofacial abnormalities that may make mask ventilation difficult.

Data from the PSRC demonstrates that recent & current upper respiratory infections (URI) increase the frequency of
airway adverse events (AAE – coughing, bronchospasm, laryngospasm). Current URI with thick secretions is
associated with the highest frequency of AAE. Even mild URIs have been associated with increased frequency of
adverse airway events13. The urgency of the procedure must be discussed with the involved parties 13,14.

Careful consideration should be taken before performing procedural sedation on ASA III or IV patients with AAP
guidelines recommending a consult with the anesthesia service before proceeding4. Extra consideration should be
given to young age, history of prematurity15, airway malformations, developmental conditions, and patients at risk of
aspiration 10,11. Patients with a history of obstructive sleep apnea, obesity 16, myopathy, or syndromes (e.g. Trisomy
21) should be carefully evaluated prior to undergoing sedation. They may have increased sensitivity to medications
or prolonged recovery times requiring admission for observation and full recovery to baseline status after sedation11.

FASTING CRITERIA

Regurgitation and pulmonary aspiration are rare events17, however sedative agents may impair protective airway
reflexes. Current recommendations regarding fasting for elective sedation cases are based on the ASA guidelines18.

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publication contains material copyrighted by others. Individual refresher course lectures are reprinted by ASA with permission.
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The PSRC conducted a review of aspiration episodes and major adverse events around NPO status, ASA PS, and
urgency of the procedure. In 139,142 PSA cases they reviewed, they found no deaths, 10 aspirations and 75 major
complications. Aspiration occurred in 8 patients who were NPO and 2 patients who were not NPO. It was
determined that NPO status is NOT an independent predictor of major complications or aspiration in the cases
reviewed19.

The American College of Emergency Physicians and the International Committee for the Advancement of
Procedural Sedation guidelines support less restrictive fasting policies for brief and urgent procedures. They report
a low incidence of pulmonary aspiration with variable fasting times 20,21. They focus on the need to balance the
urgency of the procedure with the depth of sedation. 17,19,21-26

Two pediatric anesthesia societies in Europe now support allowing all children to take clear fluids up to 1 hour
before general anesthesia27. This change has not been implemented in the ASA fasting guidelines due to insufficient
evidence to support the safety or harm of clear liquids for 1 hour vs 2 hours before procedures 18.

PERSONNEL AND EQUIPMENT

Sedation for pediatrics is administered by a variety of health care professionals. It is critically important to use a 2-
provider model where patient sedation and monitoring is provided by a person separate from the proceduralist4,8. All
providers who sedate children should be credentialed in Pediatric Advanced Life Support (PALS) and trained in
airway management and vascular access. Providers should be able to recognize and rescue an obstructed airway and
provide positive pressure ventilation. Ideally the sedation provider is able to perform invasive airway techniques
including intubation. In non-hospital locations, additional personnel with PALS certification should be available to
assist while emergency medical services are en route. Maintenance of skills for both rare and common issues are
important to practice via either simulation or working in the operating room 4,28-31.

A dedicated pediatric sedation cart should be stocked and maintained with airway, monitoring, and vascular access
equipment for patients of all ages and sizes1,4. Use of emergency checklists is recommended and should be available
wherever sedation is provided. Sample procedure checklists can be found on-line and in the literature. 32-34 If local
anesthesia is administered, medications for treatment of local anesthetic toxicity should be available.

MONITORS

Pre-procedure vital signs should be obtained and post-procedure monitoring done until the patient is ready for
discharge. Monitoring should include oxygenation, ventilation and circulation 4,35, including a pulse oximeter,
continuous EKG with blood pressure and heart rate monitoring every 5 minutes. The use of exhaled carbon dioxide
is required for deep sedation and should be strongly considered for moderate sedation. 36,37 The pre-tracheal/pre-
cordial stethoscope has recently found renewed vigor when used in conjunction with capnography by increasing the
ability to identify adverse respiratory events38. Monitoring devices must be checked regularly.

Monitoring should also include clinical signs of the depth of sedation and evaluation of pain and distress. Sedation
scales can be utilized (e.g. Ramsay & Michigan Sedation Scale). 39-41 Additional tools for monitoring level of
sedation can include processed EEGs (e.g Bispectral Index Monitor [BIS], SedLine). Processed EEG is not as
reliable in children under sedation as it is for general anesthesia42-46. Some commonly given sedation medications
such a ketamine47 & dexmedetomidine48 can also alter the BIS reading, limiting the monitor’s usefulness when these
medications are used.

DOCUMENTATION AND CONSENT

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Prior to the sedation, the patient and parent/guardian should be given information regarding the risks, benefits and
alternatives. The child should be provided developmentally appropriate information. The discussion should include
the possibility of sedation failure and options if the child is unable to complete the procedure. It may be helpful to
have a prearranged agreement between the sedation service and the anesthesia department regarding escalation of
sedation to general anesthesia in certain circumstances. Written consent should be obtained and documented
according to local and institutional requirements1,4,49-51.

Documentation should be standardized (electronic or paper) and also include the pre-sedation assessment of the
patient, a sedation record (including monitoring data, time and dosage of all medications or inhaled gases, any
adverse events) and post-procedural recovery record1,4. This document should be available for future sedation
procedures or anesthetics for review. A quality improvement process, which evaluates sedation failures or adverse
events, should be incorporated to improve the institutional system, patient care and safety 4,52.

MEDICATIONS

In the past, most sedation was administered by nurses and directed by non-anesthesiologists using medications such
as pentobarbital, chloral hydrate, fentanyl and midazolam. Newer medications tend to have shorter half-lives but
may provide an increased depth of sedation. Cote noted serious adverse events due to concurrent use of multiple
sedatives, particularly when there were any of the following: 3 or more medications used, nitrous oxide in
combination with other sedatives, and medications with long half lives53. Providers giving sedation need a thorough
understanding of the sedatives’ pharmacodynamics, pharmacokinetics, interactions and side effects.

Familiarity with reversal medications is important for sedation providers. Flumazenil is a central-acting
benzodiazepine antagonist which can reverse the respiratory depression caused by midazolam. It can be effective IV
or IN. Naloxone is an opioid antagonist which can reverse the respiratory depression caused by opiates. It can be
given administered IV, IM/SQ, or IN54. It is important to monitor patients who have received reversal agents for an
extended period of time due to the risk of resedation after the reversal agent wears off.

SPECIAL CONSIDERATIONS FOR VARIOUS OFF-SITE LOCATIONS

Radiology—Radiology locations have challenges due to non-moveable equipment (such as a fixed c-arm) which can
impede the access to a patient. MRI scanners pose additional considerations as standard rescue equipment cannot be
taken into Zone IV of the scanner55. In a critical situation, the patient must be removed from the scanner & Zone IV,
while beginning resuscitative efforts.

Radiation oncology–These are often “shared locations” where the pediatric procedure occurs within an adult facility.
It is important to have separate pediatric specific monitors, supplies & equipment. There needs to be a method for
visualizing and monitoring the patient while the patient is receiving radiation. Cameras to visualize that patient &
monitors during the radiation session are essential.

Oncology/floor procedures–If sedation is frequently performed in these areas, a fully stocked pediatric sedation cart
with equipment and medications is necessary. A plan also must be made for recovery of these patients. Many
hospital units have a nurse to patient ratio which is inadequate to observe a patient recovering from sedation if they
receive more than mild sedation. Child life specialists can be particularly useful in these areas, potentially avoiding
the need for sedation.

Non-hospital locations–Dental offices and stand-alone imaging centers are limited in their ability to have extra help
available. Sedation providers in these locations must know their environment and the abilities and skills of their
support staff extraordinarily well. Pediatric airway equipment, medications, monitors and IV access supplies, must

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be present and evaluated routinely. In the event of a major resuscitation, the team providing sedation must support
the patient until the arrival of emergency medical services.

RECOVERY

The recovery area should be equipped with oxygen, suction, and emergency airway equipment. Emergency
medications, including reversal and code medications, should be easily accessible. Pulse oximetry, blood pressure,
heart rate and rhythm should be monitored continuously for deeply sedated patients. Monitoring should be continued
until the patient is easily aroused, has a patent airway with recovery of protective reflexes and is hemodynamically
stable4.

Ex-preterm infants less than 60 weeks post-conceptual age have a higher risk of apnea after receiving sedative
medications and consideration should be given to overnight admission and monitoring1,4. At discharge, the patient
should be awake with normal vital signs for age, adequate control of nausea, vomiting and pain. Prior to discharge,
the caregiver should be given verbal and written instructions on post-procedural care.

1. Zielinska M, Bartkowska-Sniatkowska A, Becke K, et al. Safe pediatric procedural sedation and analgesia
by anesthesiologists for elective procedures: A clinical practice statement from the European Society for Paediatric
Anaesthesiology. Paediatr Anaesth. Jun 2019;29(6):583-590. doi:10.1111/pan.13615
2. Kamat PP, McCracken CE, Simon HK, et al. Trends in Outpatient Procedural Sedation: 2007-2018.
Pediatrics. May 2020;145(5)doi:10.1542/peds.2019-3559
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critical incident analysis of contributing factors. Pediatrics. Apr 2000;105(4 Pt 1):805-14.
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4. Cote CJ, Wilson S, American Academy Of P, American Academy Of Pediatric D. Guidelines for
Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and
Therapeutic Procedures. Pediatrics. Jun 2019;143(6)doi:10.1542/peds.2019-1000
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6. Biber JL, Allareddy V, Allareddy V, et al. Prevalence and Predictors of Adverse Events during Procedural
Sedation Anesthesia-Outside the Operating Room for Esophagogastroduodenoscopy and Colonoscopy in Children:
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7. Distinguishing Monitored Anesthesia Care (ʺMACʺ) from Moderate Sedation/Analgesia (Conscious
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8. Agarwal R, Kaplan A, Brown R, Cote CJ. Concerns Regarding the Single Operator Model of Sedation in
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2000;2(1):15-20. doi:10.1017/s1481803500004346
10. Richa F, Chalhoub V. Safety in pediatric sedation: practice makes perfect. Minerva Anestesiol. Oct
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12. Flick RP, Wilder RT, Pieper SF, et al. Risk factors for laryngospasm in children during general anesthesia.
Paediatr Anaesth. Apr 2008;18(4):289-96. doi:10.1111/j.1460-9592.2008.02447.x
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Adverse Events in Pediatric Procedural Sedation. Pediatrics. Jul 2017;140(1)doi:10.1542/peds.2017-0009

Refresher Course Lectures Anesthesiology 2023 © American Society of Anesthesiologists. All rights reserved. Note: This
publication contains material copyrighted by others. Individual refresher course lectures are reprinted by ASA with permission.
Reprinting or using individual refresher course lectures contained herein is strictly prohibited without permission from the
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14. Tait AR, Malviya S. Anesthesia for the child with an upper respiratory tract infection: still a dilemma?
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16. Scherrer PD, Mallory MD, Cravero JP, et al. The impact of obesity on pediatric procedural sedation-related
outcomes: results from the Pediatric Sedation Research Consortium. Paediatr Anaesth. Jul 2015;25(7):689-97.
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19. Beach ML, Cohen DM, Gallagher SM, Cravero JP. Major Adverse Events and Relationship to Nil per Os
Status in Pediatric Sedation/Anesthesia Outside the Operating Room: A Report of the Pediatric Sedation Research
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sedation and analgesia in a pediatric emergency department: are they related? Ann Emerg Med. Nov
2004;44(5):454-9. doi:10.1016/j.annemergmed.2004.03.015
21. Green SM, Leroy PL, Roback MG, et al. An international multidisciplinary consensus statement on fasting
before procedural sedation in adults and children. Anaesthesia. Mar 2020;75(3):374-385. doi:10.1111/anae.14892
22. Bhatt M, Johnson DW, Chan J, et al. Risk Factors for Adverse Events in Emergency Department
Procedural Sedation for Children. JAMA Pediatr. Oct 1 2017;171(10):957-964.
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23. Borland LM, Sereika SM, Woelfel SK, et al. Pulmonary aspiration in pediatric patients during general
anesthesia: incidence and outcome. J Clin Anesth. Mar 1998;10(2):95-102. doi:10.1016/s0952-8180(97)00250-x
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25. Green SM. Fasting is a consideration—not a necessity—for emergency department procedural sedation and
analgesia. Annals of Emergency Medicine. 2003;42(5):647-650. doi:10.1016/s0196-0644(03)00636-x
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27. Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective
pediatric general anesthesia. Paediatr Anaesth. May 2018;28(5):411-414. doi:10.1111/pan.13370
28. Teng WN, Su BC, Cheng HW. Innovation in sedation and analgesia training. Curr Opin Anaesthesiol. Aug
2019;32(4):472-479. doi:10.1097/ACO.0000000000000757
29. Sauter TC, Hautz WE, Hostettler S, et al. Interprofessional and interdisciplinary simulation-based training
leads to safe sedation procedures in the emergency department. Scand J Trauma Resusc Emerg Med. Aug 2
2016;24:97. doi:10.1186/s13049-016-0291-7
30. Fehr JJ, Chao J, Kuan C, Zhong J. The important role of simulation in sedation. Curr Opin Anaesthesiol.
Mar 2016;29 Suppl 1:S14-20. doi:10.1097/ACO.0000000000000313
31. Friedman N, Sagi D, Ziv A, Shavit I. Pediatric residents' simulation-based training in patient safety during
sedation. Eur J Pediatr. Dec 2018;177(12):1863-1867. doi:10.1007/s00431-018-3241-8
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Sedation Safety Checklist and Its Impact on Risk Reduction. Hosp Pediatr. Apr 2017;7(4):225-231.
doi:10.1542/hpeds.2016-0089

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Reprinting or using individual refresher course lectures contained herein is strictly prohibited without permission from the
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33. Anesthesia SfP. Critical Events Checklist. https://pedsanesthesia.org/wp-

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procedural sedation: a meta-analysis. J Clin Anesth. May 2011;23(3):189-96. doi:10.1016/j.jclinane.2010.08.012
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38. Boriosi JP, Zhao Q, Preston A, Hollman GA. The utility of the pretracheal stethoscope in detecting
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40. Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation
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and spectral entropy of the electroencephalogram under sevoflurane anaesthesia. Br J Anaesth. Mar 2005;94(3):336-
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48. Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG
in children. Paediatr Anaesth. Dec 2009;19(12):1175-83. doi:10.1111/j.1460-9592.2009.03160.x
49. Tobias JD. Sedation of infants and children outside of the operating room. Curr Opin Anaesthesiol. Aug
2015;28(4):478-85. doi:10.1097/ACO.0000000000000203
50. Ramaiah R, Bhananker S. Pediatric procedural sedation and analgesia outside the operating room:
anticipating, avoiding and managing complications. Expert Rev Neurother. May 2011;11(5):755-63.
doi:10.1586/ern.11.52
51. Mason KP, Seth N. Future of paediatric sedation: towards a unified goal of improving practice. Br J
Anaesth. May 2019;122(5):652-661. doi:10.1016/j.bja.2019.01.025

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52. Roback MG, Green SM, Andolfatto G, Leroy PL, Mason KP. Tracking and
Reporting Outcomes Of Procedural Sedation (TROOPS): Standardized
Quality Improvement and Research Tools from the International Committee
for the Advancement of Procedural Sedation. Br J Anaesth. Jan
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