1 guideline on the elective use of conscious sedation ... · 1 1 guideline on the elective use of...

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Guideline on the elective use of conscious sedation, minimal, moderate, and 1 deep sedation and general anesthesia for pediatric dental patients 2 Originating Group 3 American Academy of Pediatric Dentistry 4 Review Council 5 Ad Hoc Committee on Sedation and Anesthesia 6 Adopted 7 1985 8 Revised 9 1993, 1996, 1998, 2004 10

Purpose 11 The American Academy of Pediatric Dentistry (AAPD) intends this guideline to assist 12 the practitioner who will use sedation or general anesthesia for managing pediatric 13 dental patients in an outpatient or private practice site. These modalities are part of the 14 continuum of both nonpharmacological and pharmacological behavior management 15 techniques which are described in other guidelines of the AAPD1 .The guideline must be 16 tailored to the individual patient and practitioner, and safety and quality of care must be 17 of the utmost importance. The recommendations in this document may be exceeded at 18 any time if the outcome of the change involves improved safety and is supported by 19 currently accepted practice (evidence-based dentistry and medicine) and peer reviewed 20 research. This guideline is not intended to include the use of nitrous oxide/oxygen 21 inhalation sedation delivered through nasal mask when used alone or in conjunction 22 with local anesthesia. In addition, it is beyond the scope of this document to dictate the 23 use of any specific agent or agents and doses for the purpose of sedation. Monitoring 24 and equipment appropriate for medications and doses must be provided consistent with 25 the level of sedation achieved rather than that intended by the practitioner. The 26 practitioner must be prepared for inadvertent changes in the depth and length of the 27 sedation and be able to provide a safe environment for the successful outcome of the 28 procedure2,3 . 29 Methods 30 This guideline on the Elective Use of Minimal, Moderate, and Deep Sedation and 31 General Anesthesia for Pediatric Dental Patients replaces the document entitled 32 Guideline on the Elective Use of Conscious Sedation, Deep Sedation, and General 33 Anesthesia in the Pediatric Dental Patients4. This new document reflects the many 34 changes in delivery and definitions that have occurred in these modalities since the 35 original document was proposed and accepted. Advances in pain and anxiety control, 36 pharmacology and pharmacokinetics, monitoring, and patient safety are represented. 37 Specific monitoring equipment and recommendations are listed in the template of these 38 guidelines (Appendix I). Research will continue to improve the many aspects of care 39 given to the pediatric patient and will be represented in future revisions. 40 Background/Literature Review 41 The number of sedation and general anesthesia procedures performed on dental patients 42 in non-traditional settings (i.e. office or outpatient facilities) has risen over the last few 43

Guideline on the elective use of 2 sedation and general anesthesia

years as needs have increased, reimbursement levels for in-hospital procedures have 44 decreased, and safety and effectiveness of drugs and monitors have improved 45 significantly5-8. There has also been recognition by the profession and state boards for 46 increased training in sedation when provided in outpatient facilities including the 47 private dental office. 48 Studies have demonstrated the safety and effectiveness of sedation when and if the 49 practitioner follows sedation guidelines and uses drugs in recognized therapeutic levels 50 9-12. It is understood that there is extreme variability in the physiology of children even of 51 the same age; their response to all medications, including sedative and anesthetic agents, 52 is only generally predictable for the average child. These guidelines cannot and do not 53 predict nor guarantee a specific patient outcome. Unintended loss of protective reflexes 54 as well as recognition of other sedation-related untoward episodes will lead the trained 55 practitioner to provide the currently recognized concept of rescue from deeper levels of 56 sedation or other emergencies. Advanced training in recognition and management of 57 pediatric emergencies is crucial to providing safe sedation and anesthetic care. 58 The American Academy of Pediatric Dentistry (AAPD)�s Guidelines for the Elective Use 59 of Pharmacological Conscious Sedation and Deep Sedation in Pediatric Dental Patients 60 were revised and published in 1996. At that time, no attempt was made to address the 61 issue of general anesthesia for pediatric dental patients. However, sSome children and 62 developmentally disabled patients require general anesthesia services to receive 63 comprehensive dental care in a humane fashion. Access to hospital-based general 64 anesthesia may be limited for a variety of reasons including restriction of coverage by 65 certain insurance companies. Many pediatric dentists (and others who treat children) 66 have sought to provide general anesthesia in their office or other 67 facilities (eg, outpatient care clinics). Therefore, we have included general anesthesia in 68 the 69 guidelines to help facilitate safe anesthesia services for pediatric dental patients. 70 In 1985, the AAPD established the Guidelines for the Elective Use of Conscious 71 Sedation, Deep Sedation, and General Anesthesia in Pediatric Patients. To be consistent 72 with all aspects of delivery of care using pharmacologic interventions, it is appropriate 73 and timely to expand and 74 institute guidelines that address general anesthesia as well as sedation for those 75 practitioners who provide care to pediatric dental patients. General anesthesia may be 76 used when indicated for the delivery of oral health care to pediatric patients. It must be 77 provided only by qualified and appropriately trained individuals and in accordance 78 with state regulation. Such providers may include pediatric dentists who have 79 completed advanced education in anesthesiology, dental or medical anesthesiologists, 80 oral surgeons or certified registered nurse anesthetists. 81 The 1998 AAPD guidelines revision reflects the current understanding of appropriate 82 monitoring needs and provides further definitions and characteristics of 5 functional 83 levels of sedation and general anesthesia involving pediatric patients in the context of 84 recognized sedation terminology (ie, �conscious� and �deep�). Appendix I provides a 85 descriptive template for recognizing that sedation is a continuum; however, the 86

3 Guideline on the elective use of sedation and general anesthesia

practitioner�s expected clinical outcomes in sedating the �average� patient can be 87 targeted with the targeting being dependent on his/her training and 88 experience in the use of sedative agents. The template shows 5 levels of sedation, each 89 with its own goals, characteristics and requirements. 90 The pediatric dentist must be responsible for evaluating the qualifications of the general 91 anesthesia provider and establishing a safe environment which complies with state rules 92 and regulations as well as these guidelines for the protection of the patient. Educational 93 qualifications for general anesthesia providers are outlined in these guidelines. 94 Educational preparation, while necessary, is only 1 aspect of safe general anesthesia 95 care. As outlined in the guideline, the following are all essential to minimize the risk for 96 the patient who will receive sedation or general anesthesia: 97 1. facilities and equipment; 98 2. selection of pharmacologic agents and dosages; 99 3. monitoring and documentation; 100 4. patient selection utilizing physical status and indication for anesthetic management; 101 5. preoperative evaluation; 102 6. appropriately trained support personnel; 103 7. emergency medications, equipment, and protocols. 104 Appropriate levels of training required for the administration of sedation and general 105 anesthesia are found in other guidelines and policy statements13,14 and the appropriate 106 sections of the American Dental Association Guidelines for Teaching the 107 Comprehensive Control of Anxiety and Pain in Dentistry 12 . 108 The use of conscious sedation, deep sedation and general anesthesia will be affected by 109 advances in pain and anxiety control, pharmacologic development and monitoring and 110 patient safety techniques. As research defines safer and more effective techniques, the 111 guidelines will be revised accordingly. 112

Definition of terms 113 For the purpose of this document, the following definitions shall apply: 114 Guidelines: Guidelines are systematically developed recommendations to assist 115 practitioner and patient decisions about appropriate health care for specific clinical 116 circumstances. These recommendations may be adopted, modified, or rejected 117 according to clinical needs and constraints. Guidelines are not intended as standards or 118 absolute requirements and their use cannot guarantee any specific outcome. Like a 119 recommendation, it originates in an organization 120 with acknowledged professional stature. Although it may be unsolicited, it usually is 121 developed following a stated request or perceived need for such advice or instruction. 122 Pediatric dental patients: Includes all patients who are infants, children and adolescents 123 less than the age of majority. 124


Must or shall: Indicates an imperative need and/or duty; as essential or indispensable; 125 mandatory. 126 Should: Indicates the recommended need and/or duty; highly desirable. 127 May or could: Indicates freedom or liberty to follow a suggested or reasonable 128 alternative. 129 Continual: repeated regularly and frequently in a steady succession. 130 Continuous: prolonged without any interruption at any time. 131 Time-oriented record: documentation of physiologic data obtained at appropriate 132 intervals during patient monitoring and of other related material (eg, drugs, doses, and 133 route of administration) 134 Immediately available: on site in the facility and available for immediate use. 135 Sedation: Pharmacological sedation is mediated by the administration of an agent or 136 combination of agents causing alterations in the level of consciousness, cognition, motor 137 coordination, degree of anxiety, and physiological parameters. These changes are 138 dependent on the drug, dose, route of administration and individual sensitivity to the 139 agent(s). Because of differences among individuals, the process of clinical sedation 140 requires the practitioner to have special knowledge, training, consistent application of 141 sedation principles, and management of the patient in a setting optimal for safety and 142 positive outcomes. Sedation is not defined by specific medications or their doses but 143 instead by the response of the patient therefore the practitioner must be able to respond 144 appropriately to unintended levels or changes in levels of sedation in order to provide a 145 safe outcome for the patient. 146 Conscious sedation: Conscious sedation (Appendix I, levels 1, 2 and 3) is a controlled, 147 pharmacologically induced, minimally depressed level of consciousness that retains the 148 patient�s ability to maintain a patent airway independently and continuously and 149 respond appropriately to physical stimulation and/or verbal command. The drugs, 150 dosages and 151 techniques used should carry a margin of safety which is unlikely to render the child 152 noninteractive and nonarousable (Appendix I, levels 4 and 5). 153 Deep sedation: Deep sedation (Appendix I, level 4) is a controlled, pharmacologically 154 induced state of depressed consciousness from which the patient is not easily aroused 155 and which may be accompanied by a partial loss of protective reflexes, including the 156 ability to maintain a patent airway independently and/or respond purposefully to 157 physical stimulation or verbal command. 158 General anesthesia: General anesthesia (Appendix I, level 5) is an induced state of 159 unconsciousness accompanied by partial or complete loss of protective reflexes, 160 including the 161 ability to independently maintain an airway and respond purposefully to physical 162 stimulation or verbal command. 163


Minimal Sedation: (AAPD 1998 Level 14) is a drug-induced state during which patients 164 respond normally to verbal commands. Although cognitive function and coordination 165 may somewhat be impaired, ventilatory and cardiovascular functions are unaffected. 166 Moderate Sedation: (AAPD 1998 Level 2,34) is a drug-induced depression of 167 consciousness during which patients respond purposefully to verbal commands (eg, 168 "open your eyes�), either alone or accompanied by light tactile stimulation. For older 169 patients, this level of sedation implies an interactive state if prompted by the provider; 170 for younger patients, age-appropriate behaviors occur and are expected (eg, crying). 171 Reflex withdrawal, although a normal response to a painful stimulus, is not considered 172 acceptable as the only purposeful response for this level of sedation. No interventions 173 are required to maintain a patent airway and spontaneous ventilation is adequate unless 174 maneuvers mediated by the procedure and practitioner potentially affect the airway. 175 Such maneuvers should be corrected immediately as a part of facilitating the patient�s 176 ability to maintain airway patency. Cardiovascular function usually is unaffected. 177 Deep Sedation(AAPD 1998 Level 3,44) is a drug-induced depression of consciousness 178 during which patients cannot be easily aroused, but may respond purposefully 179 following repeated verbal or painful stimulation. The ability to maintain ventilatory 180 function independently may be impaired. Patients may require assistance in 181 maintaining a patent airway, regardless of the procedure and practitioner 182 manipulations, and spontaneous ventilation may be inadequate. Cardiovascular 183 function usually is unaffected. Reflex withdrawal from a painful stimulus may occur, 184 but is not considered as a higher functioning and purposeful response. It may be 185 accompanied by a partial or complete loss of protective airway reflexes. The state and 186 risks of deep sedation may be indistinguishable from those of general anesthesia. 187 General Anesthesia: (AAPD 1998 Level 54) is a drug-induced loss of consciousness 188 during which the patient is not arousable, even by painful stimulation. The ability to 189 maintain ventilatory function independently often is impaired. Patients often require 190 assistance in maintaining a patent airway, and positive pressure ventilation may be 191 required because of depressed spontaneous ventilation or drug-induced depression of 192 neuromuscular function. Cardiovascular function may be impaired. 193 Rescue: It is not always possible to achieve the intended level of sedation for any given 194 patient and some patients may progress to a deeper level of sedation or general 195 anesthesia than expected by the practitioner 2,3 . The patient may demonstrate an 196 inability to maintain his/her airway independently and hypoventilation, obstruction 197 and/or cardiovascular compromise may occur. The practitioner must have the training, 198 skills, and equipment to identify and manage such an occurrence until either assistance 199 arrives (emergency medical services) or the patient returns to the intended level of 200 sedation without airway or cardiovascular complications. 201

General considerations 202 Goals of sedation and general anesthesia 203 The sedation of children for the delivery of oral health care is recognized as and 204 represents a unique clinical challenge. Consideration must be given to such factors as 205 patient�s age and corresponding levels of cognitive and coping skills. Because of patient 206


extremes in responsiveness and acceptability of treatment modalities, the intended goals 207 and outcome of sedations will vary depending on a host of factors. These guidelines 208 should aid clinicians in achieving the benefits of sedation while minimizing associated 209 risks and adverse outcomes for the patient. The goals of sedation in the pediatric dental 210 patient are to: 211 1. facilitate and augment the provision of quality care; 212 2. minimize the extremes of disruptive behavior; 213 3. promote a positive psychological response to treatment; 214 4. promote patient welfare and safety; 215 5. return the patient to a physiological state in which safe discharge, as determined by 216 recognized criteria, is possible (Appendix II). 217 The goals of general anesthesia in the pediatric dental patient are to eliminate cognitive, 218 sensory, and skeletal motor activity in order to facilitate the delivery of quality 219 comprehensive diagnostic, and restorative, and/or other dental services. 220 Indications for sedation and general anesthesia 221 The I Indications for conscious minimal or moderate sedation include: 222 1. preschool children requiring dental treatment who cannot understand or cooperate 223 for definitive treatment; 224 2. patients requiring dental care who cannot cooperate due to lack of psychological or 225 emotional maturity; 226 3. patients requiring dental treatment who cannot cooperate due to a cognitive, physical, 227 or medical disability; 228 4. patients who require dental care but are fearful and anxious; and cannot cooperate for 229 treatment. 230 5. patients who require extensive dental care and would require or benefit from 231 prolonged visits. 232 The indications for deep sedation and general anesthesia in pediatric dental patients 233 include: 234 1. patients with certain physical, mental, or medically compromising conditions; 235 2. patients with dental restorative or surgical needs for whom local anesthesia is 236 ineffective; 237 3. the extremely uncooperative, fearful, anxious, or physically resistant child or 238 adolescent with substantial dental needs and no expectation that the behavior will 239 improve soon; 240 4. patients who have sustained extensive orofacial or dental trauma; 241 5. patients with dental needs who otherwise would not receive comprehensive dental 242 care. 243


1. patients who are unable to cooperate due to a lack of psychological or emotional 244 maturity and/or mental, physical or medical disability; 245 2. patients for whom local anesthesia is ineffective because of acute infection, anatomic 246 variations, or allergy; 247 3. the extremely uncooperative, fearful, anxious, or uncommunicative child or 248 adolescent 249 4. patients requiring significant surgical procedures; 250 5. patients for whom the use of deep sedation or general anesthesia may protect the 251 developing psyche and/or reduce medical risks; 252 6. patients requiring immediate, comprehensive oral/dental care1. 253 Local anesthesia considerations during sedation 254 All local anesthetic agents can become cardiac and central nervous system (CNS) 255 depressants when administered in excessive doses. There is a potential interaction 256 between local anesthetic and sedatives used in pediatric dentistry which can result in 257 enhanced sedative effects and/or untoward events. Therefore, particular attention 258 should be paid to doses used in children. To avoid excessive doses for the patient who is 259 going to be sedated, a maximum recommended 260 dose in based upon mg/kg or mg/lb should be calculated and t. The dose of all 261 sedatives and local anesthetics administered should must be recorded on the time-based 262 record for each patient prior to administration for all sedatives and local anesthetics. It 263 is beyond the scope of this document to recommend specific dosages of local anesthetic 264 agents. 265 Candidates 266 Patients who are ASA (American Society of Anesthesiologists) Class I or II (Appendix 267 III) may be considered candidates for conscious sedation (Appendix I, levels 1, 2 or 3) 268 minimal, moderate, or deep sedation (Appendix I, level 4) or general anesthesia 269 (Appendix I, level 5). Patients in ASA Class III or IV present special problems and 270 treatment in a hospital setting should be considered. 271 Responsible adult 272 The pediatric patient shall be accompanied to and from the treatment facility by a 273 parent, legal guardian or other responsible adult who shall be required to remain at the 274 facility for the entire treatment period. A second responsible person is encouraged to 275 accompany the patient to assist the parent, legal guardian, or other responsible adult in 276 observing the patient while being transported in a motor vehicle. 277 Facilities and equipment 278 Facilities 279 The practitioner who utilizes any type of sedative or local anesthetic in a pediatric dental 280 patient shall possess appropriate training and skills and have available the proper 281 facilities, personnel, and equipment to manage any reasonably foreseeable emergency 282 situation that might be experienced. All newly installed systems or remodeled facilities 283


for delivering nitrous oxide and oxygen must be checked for proper gas delivery and 284 fail-safe function prior to initial use. Where equipment and facilities are mandated 285 regulated by state law, such statutes shall supersede these guidelines. 286 Equipment 287 A positive-pressure oxygen delivery system that is capable of administering greater than 288 90% oxygen at a 10 L/min flow for at least 60 minutes (650 liter, �E� cylinder) must be 289 available. When a self-inflating bag valve mask device is used for delivering positive 290 pressure oxygen, a 15 L/min flow is recommended. All eEquipment must be able to 291 accommodate children of all ages and sizes. 292 A functional suction apparatus with appropriate suction catheters (eg, tonsillar and 293 flexible) must be immediately available. A sphygmomanometer with cuffs of 294 appropriate size for pediatric patients shall be immediately available and utilized during 295 the procedure and the recovery phase of the procedure as recommended. Monitoring 296 devices such as pulse oximeters, end tidal carbon dioxide monitors, and automated 297 blood pressure cuffs must be maintained and safety tested regularly according to 298 manufacturer�s guidelines or regulations to guarantee their correct function. 299

Inhalation sedation equipment must have the capacity for delivering 100%, and never 300 less than 25%, oxygen concentration at a flow rate appropriate to the child�s size, and 301 must have a fail-safe system that is checked and calibrated annually. If nitrous oxide and 302 oxygen delivery equipment 303 capable of delivering more than 75% nitrous oxide and less than 25% oxygen is used, an 304 in-line oxygen analyzer must be used. The equipment must have an appropriate 305 scavenging system. 306 Equipment that is appropriate for the technique used and capable of monitoring the 307 physiologic state of the patient before, during and after the procedure must be present. 308 Specific monitoring equipment monitoring and recommendations are listed in the 309 sections on conscious sedation, minimal, moderate, and deep sedation and general 310 anesthesia and in the template of these guidelines (Appendix I). 311 An emergency cart or kit (Appendix IV) must be readily accessible and should include 312 the necessary drugs and age- and size-appropriate equipment to resuscitate and rescue a 313 nonbreathing and unconscious pediatric dental patient and provide continuous support 314 while the patient is being transported to a medical facility. There should be 315 Documentation that all emergency equipment and drugs are checked and maintained on 316 a regularly scheduled basis (eg, monthly; see Appendix IV for suggested drugs) must be 317 kept. 318 Backup emergency services 319 Backup emergency services should be identified. A protocol outlining necessary 320 procedures for their immediate employment should be developed and operational for 321 each facility. For nonhospital facilities, an emergency assist system should be established 322 with the nearest hospital 323 emergency facility and ready access to ambulance service must be assured. 324 Additionally, office protocols for staff assistance during emergencies or untoward 325 events should be developed and emergency scenarios practiced on a regular basis. 326


Documentation 327 The practitioner must document each sedation or general anesthesia procedure in the 328 patient�s record. Documentation shall include the following: 329 Informed consent 330 Each patient, parent, or other responsible individual is entitled to be informed regarding 331 benefits, risks, and alternatives to sedation or general anesthesia and to give consent. 332 The patient record shall document that appropriate informed consent was obtained 333 according to the procedures 334 outlined by individual state laws and/or institutional requirements. 335 Instructions to parents or responsible individual 336 The practitioner shall provide verbal and written instructions to the parent(s) or 337 responsible individual. Instructions should be explicit and include an explanation of 338 presedation and postsedation dietary precautions, potential or anticipated post-339 operative behavior, and limitation of activities. A 24-hour contact number for the 340 practitioner should be provided to all patients. 341 Dietary precautions 342 The administration of sedative drugs or general anesthetic agents shall be preceded by 343 an evaluation of the patient�s food and liquid intake. Intake of food and liquids should 344 be limited prior to treatment as follows: 345 1. no milk, breastmilk, formula, or solids for 6 hours for children 6 to 36 months and 6 to 346 8 hours for children 36 months and older 347 2. clear liquids up to 3 hours before procedure for children ages 6 months and older. 348 The dental procedure must be postponed if the recommendations are not followed 349 because of increased risk of aspiration should there be unintended loss of protective 350 reflexes during sedation. Patients requiring general anesthesia for emergency 351 procedures may proceed if appropriate pharmacologic and physical means are used to 352 protect the airway before and after the procedure. Patients with a known history of 353 gastroesophageal reflux or with a high potential for aspiration would benefit from 354 appropriate pharmacologic treatment or an appropriate increase in N.P.O. interval to 355 reduce gastric volume and increase gastric pH 15,16,17. 356 Preoperative health evaluation 357 The patient shall be under the routine care of a physician or appropriate medically 358 trained and licensed personnel. 359 Prior to the administration of sedatives, the practitioner shall obtain and document 360 information about the patient�s current health status. The This focused health status 361 evaluation should 362 include: 363 Health history including: 364 1. allergies and previous allergic or adverse drug reactions; 365


2. current medications (prescription, over the counter, and herbal) including dose, time, 366 route, and 367 site of administration; 368 3. diseases, disorders or physical abnormalities and pregnancy status; 369 4. previous hospitalization to include the date, purpose, and hospital course; 370 5. history of general anesthesia or sedation and any associated complications; 371 6. family history of diseases or disorders especially those which might impact sedation 372 and general anesthesia; 373 7. review of systems; 374 8. age in years and months and weight in kilograms or pounds. 375 9. Name, address, and telephone number of the child�s pediatrician or family physician. 376 It should be determined that the patient has been evaluated recently by the physican or 377 his/her licensed designee. 378 Physical evaluation including: 379 1. weight in kilograms or pounds. 380 12. vital signs, including heart and respiratory rates and blood pressure; 381 23. evaluation of airway patency and tonsil size; 382 34. risk assessment (eg, ASA classification; Appendix III). 383 Hospitalized patients 384 The current hospital record may suffice for adequate documentation of presedation 385 health. A brief note shall be written documenting that the record was reviewed, positive 386 findings were noted, and there were no contraindications to the planned procedure(s). 387 Prescriptions 388 Home administration of sedative medications poses an unacceptable risk for infants, 389 toddlers, and young children traveling in car seats.18 Their breathing is not easily 390 observed and the risk of medication administration error by untrained personnel is a 391 possibility. Administration of anxiolytic medications may be beneficial in older patients 392 but such medications when used in therapeutic doses must not possess significant 393 sedative effects capable of rendering loss of consciousness or protective reflexes. If a 394 prescription is written or medication is given for home use, the amount must be for a 395 single administration to avoid medication administration errors. Specific instructions 396 for the anxiolytic or minimal sedation medication including adverse and untoward 397 reactions must be discussed with the parent(s) or responsible adult. Administration of 398 repeated oral doses of sedative medications is not an acceptable therapeutic modality in 399 children. 400 Child�s physician 401 Name, address and telephone number of the child�s physician or family physician 402 should be recorded in the patient�s record. 403


Rationale for sedation or general anesthesia 404 The practitioner shall briefly document briefly the reason for the need for sedation or 405 general anesthesia. 406 Baseline vital signs 407 Before administration of sedatives or general anesthesia, a baseline determination of 408 vital signs (heart and respiratory rates and blood pressure) should be documented in the 409 patient�s record. If determination of baseline vital signs is prevented by the patient�s 410 physical resistance or emotional 411 condition, the reason(s) should be documented. 412 Preprocedural prescriptions 413 The only classification of drugs for sedation to be administered enterally by a 414 responsible adult preprocedurally outside the treatment facility is minor tranquilizers. 415 Minor tranquilizers (ie, hydroxyzine or diazepam) do not include chloral hydrate or 416 narcotics. A copy or a note describing the content of the prescription should be 417 documented in the patient�s record, along with a description of the instructions given to 418 the responsible individual. 419 Vital signs 420 The patient�s record shall contain documentation of intermittent quantitative 421 monitoring, and recording of oxygen saturation (pulse oximetry), and, heart and 422 respiratory rates, and blood pressure, as recommended for specific sedation techniques. 423 It should be documented that the Patient responsiveness of the patient was must be 424 monitored and documented at specific intervals before and during the procedure and 425 until the patient was is discharged. Inability to accurately monitor and record vital signs 426 at appropriate intervals because of adverse or uncontrollable patient behavior should be 427 documented but clinical observation must continue. 428 Drugs 429 The patient�s record shall document the name, dose and route, site, and time of 430 administration of all drugs, including local anesthetics, administered. The maximum 431 recommended dose per kilogram or pound should be calculated and the actual dose 432 given shall be documented in milligrams. The practitioner should calculate or have 433 readily available the dosages of emergency drugs and if appropriate, reversal agents. 434 The concentrations, flow rate, and duration of administration of oxygen and anesthetic 435 gases including nitrous oxide shall be documented. 436 Recovery 437 The condition of the child and the time of discharge from the treatment facility should 438 be documented in the record. Documentation shall include that appropriate discharge 439 criteria have been met (Appendix II). The record also should also identify the 440 responsible adult to whose care the patient was discharged. 441 Continuous Quality Improvement 442 In order to reduce medical errors including those related to sedation and general 443 anesthesia, a careful examination of index events with a complete and thorough analysis 444


of cause and effect should be undertaken. The practitioner should maintain records that 445 track events such as non-behavioral mediated desaturations, prolonged sedation, apnea 446 events, unexpected airway interventions including jaw thrust and/or positive pressure 447 ventilation prior to, during, or after procedures, and unintended hospital admission. 448 Such events then can be examined and assessed for future risk reduction and patient 449 safety. 450

Conscious Minimal and moderate sedation (levels 1, 2, 3) 451 Personnel 452 The practitioner responsible for the treatment of the patient and/or the administration 453 of drugs for conscious minimal and moderate sedation (levels 1, 2 and 3) shall be 454 appropriately trained in the use of such drugs and techniques, shall provide appropriate 455 monitoring, and shall be capable of managing and rescuing the patient from any 456 reasonable foreseeable complications including loss of airway, hypoxia, apnea, or 457 unintended progression to a deeper level of sedation. Training and certification in basic 458 life support (BLS or equivalent) is required; training and certification in advanced 459 pediatric airway management and advanced life support, such as Pediatric Advanced 460 Life Support (PALS) or Advanced Cardiac Life Support (ACLS) or equivalent, is 461 recommended. 462 Drugs, other than minor tranquilizers, used for the purpose of minimal or moderate 463 conscious sedation (levels 1, 2 and 3) shall be administered in the treatment facility and 464 shall be prescribed, dispensed, or administered only by appropriately licensed 465 individuals, or under the direct supervision thereof, according to state law. In addition 466 to the operating practitioner, an individual trained to monitor appropriate physiologic 467 parameters and to assist in any supportive or resuscitative measures required shall be 468 present. Both This individuals must have training and certification in basic life support, 469 shall have specific assignments, and shall have familiarity of be familiar with the 470 emergency cart (kit) inventory. The practitioner and all treatment facility personnel 471 should participate in periodic reviews of the office�s emergency protocol, the emergency 472 drug kit and simulated exercises to assure proper emergency management response. 473 Operating facility and equipment 474 The operating facility used for the administration of minimal and moderate conscious 475 sedation (levels 1, 2 or 3), shall have available all facilities and equipment previously 476 recommended and outlined in Appendix 1 . With the possible exception of During 477 minimal conscious sedation (level 1), the patient remains fully awake and 478 communicative but may exhibit unexpected changes in level of consciousness and depth 479 of sedation. The practitioner must maintain the equipment necessary and the ability to 480 monitor the patient at the level to which this change may occur until such time as the 481 patient returns to the original level of cognitive and physiological function.mediated by 482 minor tranquilizers administered enterally and/or nitrous oxide and oxygen inhalation 483 sedation at 50% nitrous oxide concentration or less, mMinimum monitoring equipment 484 for conscious moderate sedation (levels 2 or 3)shall be a pulse oximeter, precordial 485 stethoscope and sphygmomanometer; Ccapnography is desirable and may be 486 substituted for the precordial stethoscope. for level 3. A sphygmomanometer shall be 487 immediately available. A precordial/pretracheal stethoscope is required for level 3. 488


Monitoring procedures before and during treatment 489 Whenever drugs for conscious minimal or moderate sedation (levels 1, 2 or 3) are 490 administered, the patient should must be monitored continuously continually for 491 patient responsiveness and airway patency. With the possible exception of conscious 492 sedation (level 1), mediated by minor tranquilizers administered enterally and/or 493 nitrous oxide and oxygen inhalation sedation at 50% nitrous oxide concentration or less, 494 there shall be continual monitoring of oxygen saturation and heart and respiratory rates. 495 For the patient whose anticipated sedation level is moderate, Ooxygen saturation and 496 heart and respiratory rates shall be recorded at specific intervals throughout the 497 procedure until the child has met documented discharge criteria. A 498 precordial/pretracheal stethoscope, sphygmomanometer and/or end tidal carbon 499 dioxide monitor shall be used for obtaining additional information on heart and 500 respiratory rates and for monitoring airway patency during level 3 moderate sedations. 501 Clinical observation should accompany all levels of sedation. 502 Treatment immobilization Protective stabilization devices should be checked 503 periodically to prevent airway obstruction or chest restriction and ensure limb 504 perfusion. The child�s head position shall be checked frequently to ensure airway 505 patency. A patient who has received sedation medication must sedated patient shall be 506 observed continuously continually by a trained individual. 507 Recovery 508 After completion of the treatment procedures, vital signs should be recorded at specific 509 intervals. The patient who has received moderate sedation must be observed in a 510 suitably equipped recovery facility in which there is the availability of high volume 511 suction, oxygen with bag/mask/valve supplementation, and access to emergency 512 equipment. The practitioner or his/her designee shall must assess the patient�s 513 responsiveness and discharge the patient only when the appropriate discharge criteria 514 have been met (Appendix II). 515

Deep sedation (level 4) 516 Personnel 517 The techniques of deep sedation (level 4) require the following 3 individuals : 518 1. the treating practitioner, who may direct the sedation8,10; 519 2. a qualified individual to assist with observation and monitoring of the patient and 520 who may administer drugs if appropriately licensed8,10; 521 3. other personnel to assist the operator as necessary. 522 Of the 3 individuals, one shall be have training and certification in advanced pediatric 523 airway management and advanced life support, such as Pediatric Advanced Life 524 Support (PALS) or Advanced Cardiac Life Support (ACLS) or equivalent. trained in 525 advanced cardiac life support or pediatric advanced life support (PALS, ACLS)and tThe 526 other 2 shall be currently trained and certified in basic life support (BLS or equivalent). 527


If a certified registered nurse anesthetist is permitted to function under the supervision 528 of a dentist, the dentist is required to have completed training in deep sedation and be 529 licensed or permitted, as appropriate, as specified above. 530 Operating facility and equipment 531 In addition to the facilities and equipment previously recommended for conscious 532 minimal and moderate sedation (levels 1, 2 and 3), deep sedation requires an 533 electrocardiograph (ECG) and a 534 capnograph in conjunction with pulse oximetry. The availability of a defibrillator 535 appropriate for pediatric patients is desirable required. 536 Intravenous access 537 Patients receiving deep sedation (level 4) should have an intravenous line in place or 538 have immediately available an individual skilled in establishing vascular access in 539 pediatric patients. In special circumstances, induction of deep sedation may begin prior 540 to vascular access because of patient uncooperativeness or may occur without for a very 541 short procedure. 542 Monitoring procedures before and during treatment 543 The sedated patient shall be continuously monitored continuously by an appropriately 544 trained individual. There shall be continual monitoring of oxygen saturation by 545 oximetry and expired carbon dioxide concentration via capnography, heart and 546 respiratory rates and blood pressure, all of which shall be recorded minimally every 5 547 minutes. A pulse oximeter and capnograph, precordial/pretracheal stethoscope, ECG, 548 and blood pressure cuff are required. Temperature monitoring is desirable. The child�s 549 head position must be checked frequently to ensure airway patency. The operator 550 should be observing the patient as well as the monitors and observing trends in the data 551 obtained from the monitors. At no time shall a sedated patient be left unobserved by an 552 An appropriately trained individual must continuously observe the patient until 553 discharge. 554 Recovery 555 After treatment has been completed, the patient must be observed in a suitably 556 equipped recovery facility. This facility must have a functioning suction apparatus and 557 suction catheters of appropriate size as well as the capacity to deliver greater than 90% 558 oxygen and provide positive pressure ventilation for pediatric patients. An individual 559 experienced in recovery care must be in attendance at all times to assess and record vital 560 signs, observe the patient, and ensure airway 561 patency until the patient is stable. The patient must remain in the recovery facility until 562 cardiovascular and respiratory stability are ensured and appropriate discharge criteria 563 have been met (Appendix II). 564

General anesthesia (level 5) 565 Personnel 566 The provision of general anesthesia requires the following 3 individuals: 567


1. a physician or dentist who has completed an advanced training program in anesthesia 568 or oral and maxillofacial surgery and related subjects beyond the undergraduate 569 medical or dental curriculum, who is responsible for anesthesia and monitoring of the 570 patient 8,10 571 2. a treating dentist, responsible for the provision of dental services8,10; 572 3. other personnel to assist the operator as necessary. 573 Of these individuals, the anesthetist shall be currently certified have training and 574 certification in advanced pediatric airway management and/or advanced life support, 575 such as Pediatric Advanced Life Support (PALS), Advanced Cardiac Life Support 576 (ACLS) or equivalent. trained in advanced cardiac life support or pediatric advanced life 577 support (PALS, ACLS)and tThe others shall be trained and currently certified in basic 578 life support (BLS or equivalent). 579 If a certified registered nurse anesthetist is permitted to function under the supervision 580 of a dentist, the dentist is required to have completed training in general anesthesia and 581 be trained and certified in advanced cardiac life support or advanced pediatric airway 582 management, as specified above. 583 Operating facility and equipment 584 In addition to the facilities and equipment previously recommended for conscious 585 sedation deep sedation (level 4; ie: pulse oximeter, capnograph, precordial stethoscope, 586 blood pressure monitor, and ECG), a temperature monitor and pediatric defibrillator 587 also are also required. 588 Intravenous Access 589 Patients receiving general anesthesia should have an intravenous line in place or have 590 immediately available a individual skilled in establishing vascular access in children. In 591 special circumstances, induction of general anesthesia may begin prior to vascular access 592 because of patient uncooperativeness or for a very short procedure. 593 Monitoring procedures 594 The anesthetized patient shall be continuously monitored continuously by the 595 anesthesia provider. There shall be continual monitoring of oxygen saturation by pulse 596 oximetry, and expired carbon dioxide concentration via capnography, heart and 597 respiratory rates, and blood pressure, all of which shall be recorded minimally every 5 598 minutes. The anesthesia provider should be visualizing the patient as well as the 599 monitors and observing trends in the data obtained from the monitors. At no time 600 should the patient be unobserved by trained personnel until discharge criteria have been 601 met. An appropriately trained individual must continuously observe the patient until 602 discharge. 603 Recovery 604 After treatment has been completed, the patient must be observed continuously and 605 monitored appropriately in a suitably equipped recovery facility until the patient 606 becomes stable exhibits respiratory and cardiovascular stability through continual 607 monitoring. This facility must have a functioning suction apparatus and suction 608 catheters of appropriate size as well as the capacity to deliver greater than 90% oxygen 609


and provide positive pressure ventilation for pediatric patients. An individual 610 experienced in recovery care must be in attendance at all times to assess and record vital 611 signs, observe the patient, and ensure airway patency. The patient must remain 612 in the recovery facility until cardiovascular and respiratory parameters and function are 613 stable and appropriate discharge criteria have been met (Appendix II). 614

Appendix I 615 Template of definitions and characteristics for levels of sedation and general 616 anesthesia 617 Conscious Deep General 618 sedation sedation anesthesia 619 Functional level of sedation Mild sedation Interactive Noninteractive/ Noninteractive/ 620 General (Anxiolysis) arousable nonarousable anesthesia with mild/ except with 621 moderate stimulus intense stimulus 622 (Level 1) (Level 2) (Level 3) (Level 4) (Level 5) 623 Goal Decrease anxiety; Decrease or eliminate Decrease or eliminate Eliminate anxiety; 624 Eliminate cognitive, 625 facilitate coping skills anxiety; facilitate anxiety; facilitate coping skills sensory and 626 coping skills coping skills; over-ridden skeletal motor promote non- activity; some 627 interaction sleep autonomic activity depressed 628 Responsiveness Uninterrupted Minimally depressed Moderately depressed Deeply 629 depressed level Unconscious and 630 interactive ability; level of consciousness; level of consciousness; of consciousness; sleep- 631 unresponsive to surgical 632 totally awake eyes open or mimics physiologic sleep like state, but vitals stimuli; partial 633 or temporarily closed; (vitals not different from may be slightly depressed complete loss 634 of responds appropriately that of sleep); eyes closed compared to physiologic protective 635 reflexes to verbal commands most of time; may or sleep; eyes closed; does not including 636 the airway; may not respond to verbal respond to verbal prompts does not respond 637 prompts alone; responds alone; reflex withdrawal purposefully to physical to mild 638 /moderate stimuli with no verbalization when and verbal command (eg, repeated 639 trapezius intense stimuli occurs pinching or needle (eg, repeated, prolonged insertion in 640 oral tissues and intense pinching elicits reflex withdrawal of the trapezius); and 641 appropriate verbalization airway expected to [complaint, moan, crying]); require 642 constant monitoring airway only occasionally and frequent management may require 643 readjustment 644 via chin thrust Personnel 2 2 2 3 3 645 Monitoring Clinical PO; precordial PO, precordial, BP; PO, Capno, ECG; PO, Capno, 646 equipment observation recommended* capno desirable* precordial, BP, precordial, BP, 647 defibrillator desirable* ECG, temperature and 648 defibrillator required 649


Monitoring information None HR, RR, O2 pre-; HR, RR, O2, BP; HR, RR, O2 and HR, 650 RR, O2, during (every 15 min); CO2 if available CO2, BP, ECG CO2, BP, ECG, post, as 651 needed pre-; during pre-; during temperature pre-; (every 10 min); post (every 5 min); 652 post during (every 5 min till stable/discharge till stable/discharge minimum); post 653 criteria criteria till stable/discharge criteria 654 Monitors: PO (pulse oximetry); Capno (capnography); BP (blood pressure cuff); ECG 655 (electrocardiogram). It should be noted that clinical observation should accompany any 656 level of sedation and general anesthesia. 657 *�Recommended� and �desirable� should be interpreted as not a necessity, but as an 658 adjunct in assessing patient status 659 660

Level Minimal sedation Moderate sedation

Deep sedation General anesthesia

Goal Decrease or eliminate anxiety; facilitate coping skills

Decrease or eliminate anxiety, facilitate coping skills.

Younger patients show age- appropriate behaviors including crying; older patients demonstrate interactive state.

Eliminate anxiety; coping skills unaffected and overridden. Patient uneasily aroused but may respond to purposeful stimulation

Eliminate sensory and skeletal motor activity, autonomic activity depressed

Patient Responsiveness

Subjectively, the patient may sense and/or express less anxiety about the clinical procedure compared to pre-sedation periods. Objectively, the patient may appear more calm and less overtly responsive to clinical stimuli, and purposefully interactive with the clinician compared to pre-sedation periods.

Subjectively, the patient may sense and/or express less anxiety about the clinical procedure compared to pre-sedation periods. Objectively, the patient may appear less tense, cognizant of, but less overtly responsive to, clinical stimuli, and purposefully interactive with the clinician compared to pre-sedation periods. The patient, if

Subjectively, the patient may sense and/or express limited or no feelings of anxiety associated with the clinical procedure. Objectively, the patient may appear very relaxed, not cognizant of and minimally or non- responsive to clinical stimuli, and non-interactive with the clinician at any time. The patient would not be able independently to move his/her head

Unconscious and unresponsive to surgical stimuli.


behaviorally and cognitively cooperative, should be able independently to move his/her head and/or mandible, as directed by the clinical and to assist in maintaining optimal airway patency.

and/or mandible to maintain optimal airway patency consistent with the clinical situation and under these circumstances, requires continuous monitoring of the airway and continual assistance of the clinician (e.g., head tilt, chin lift procedure).

Physiologic changes

Patient remains stable and within age- appropriate and health status norms for parameters involving hemodynamic, ventilation, and oxygenation functions. No loss of protective reflexes

Patient remains stable and within age-appropriate and health status norms for parameters involving hemodynamic, ventilation, and oxygenation functions. No loss of protective reflexes

Patient remains stable and either minimally or moderately below the patient�s age and health status norms for hemodynamic, ventilation, and oxygenation functions. Accompanied by partial or complete loss of protective reflexes

Partial or complete loss of protective reflexes including the airway; does not respond purposefully to verbal command or physical stimulus

Personnel needed

2 2 3 3

Monitoring equipment

Clinical observation unless patient becomes moderately sedated then appropriate monitoring needed

BPC, PO, PC or Capno

BPC, PO, PC/Capno, ECG

BPC, PO, PC/Capno,

ECG, Temp

Monitoring Info and frequency

Skin color, respiratory effort.

(Continual)

HR, RR, BP, SaO2

(q15m))

HR, RR, BP, SaO2, ETCO2, EC

(q5m)

HR, RR, BP, SaO2, ETCO2, Temp, EC

(q5m)

Key to abbreviations: 661 BP: blood pressure 662 BPC: blood pressure cuff/sphygmomanometer. 663


PO: pulse oximetry 664 PC: precordial/pretracheal stethoscope 665 Capno: capnograph/end tidal CO2 carbon dioxide monitor 666 EKCG: electrocardiograph 667 HR: heart rate 668 RR: respiratory rate 669 BP: blood pressure 670 SaO2: oxygen saturation 671 ETCO2: end tidal CO2 carbon dioxide 672 Temp: temperature 673 EC: electrical conductivity as demonstrated on ECG 674

Appendix II 675 Recommended discharge criteria 676 1. cardiovascular function satisfactory and stable; 677 2. airway patency uncompromised and satisfactory; 678 3. patient easily arousable and protective reflexes intact; 679 4. state of hydration adequate; 680 5. patient can talk, if applicable; 681 6. patient can sit unaided, if applicable; 682 7. patient can ambulate, if applicable, with minimal assistance; 683 8. for the child who is very young or disabled and incapable of the usually expected 684 responses, the presedation level of responsiveness or the level as close as possible for 685 that child should be achieved; 686 9. responsible individual is available. 687

Appendix III 688 American Society of Anesthesiologists Classification (modified) 689 Class I: A normally healthy patient with no organic, physiologic, biochemical or 690 psychiatric disturbance or disease. 691 Class II: A patient with mild-to-moderate systemic disturbance or disease. 692 Class III: A patient with severe systemic disturbance or disease. 693 Class IV: A patient with severe and life-threatening systemic disease or disorder. 694 Class V: A moribund patient who is unlikely to survive without the planned procedure. 695


Class VI: A declared brain dead patient whose organs are being removed for donor 696 purposes. 697 E: Emergency operation of any variety; used as a modifier. 698

Appendix IV 699 Appropriate emergency equipment should be available whenever sedative drugs, 700 capable of causing cardiorespiratory and central nervous system depression, are 701 administered. The items below should be used as a guidereference, which should be 702 modified depending on the individual practice circumstances. 703 Emergency medications 704 1. oxygen; 705 2. ammonia spirits; 706 3. glucose (50%); 707 4. atropine; 708 5. diazepam; 709 6. epinephrine; 710 7. lidocaine (cardiac); 711 8. diphenhydramine hydrochloride; 712 9. hydrocortisone; 713 10. pharmacologic antagonists (as appropriate) ; : 714

11. naloxone hydrochloride; 715 12. flumazenil. 716

Basic Airway management equipment 717 1. nasal and oral airways of different assorted pediatric and adult sizes; 718 2. portable oxygen delivery system capable of delivering bag and mask ventilation 719 greater than 90% at 10 L/min flow for at least 60 minutes (eg, �E� cylinder); 720 3. self-inflating resuscitation breathing bag and reservoir with masks that will 721 accommodate children and adults of all sizes. 722 4. Deep sedation and general anesthesia: 723

assorted pediatric endotrachial tubes; 724 laryngoscopes with straight and curved blades; 725 Magill forceps. 726

Intravenous equipment (level 4 sedations) (deep sedation and general anesthesia) 727 1. gloves, 728 2. alcohol wipes, 729


3. tourniquets, 730 4. sterile gauze pads, 731 5. tape; 732 6. intravenous solutions and equipment for administration appropriate to the patient 733 population being treated: 734 a.intravenous catheters (22, 24 gauge) 735 b.intravenous administration set (tubing) (microdrip 60 drops/ml) 736 c.intravenous fluids 737 d.assorted needles for drug aspiration and administration 738 e.appropriately-sized syringes 739

References 740 1. AAPD, Clinical guideline on behavior management, Pediatr Dent. 2003:25(7):69-74. 741

2. Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N: Depth of 742 sedation in children undergoing computed tomography: validity and reliability 743 of the University of Michigan Sedation Scale (UMSS). Br.J.Anaesth. 2002;88:241-744 245. 745

3. Dial S, Silver P, Bock K, Sagy M: Pediatric sedation for procedures titrated to a desired 746 degree of immobility results in unpredictable depth of sedation. 747 Pediatr.Emerg.Care 2001;17:414-420. 748

4. AAPD, Guideline on the elective use of conscious sedation, deep sedation and general 749 anesthesia in pediatric dental patients; Pediatr Dent. 2003;25(7):73-78. 750

5. Houpt M., Report of project USAP: the use of sedative agents in pediatric dentistry. 751 ASDC J Dent Child, 1989;56:302-309. 752

6. Houpt M., Project USAP the use of sedative agents in pediatric dentistry: 1991 update. 753 Pediatr Dent, 1993;15:36-40. 754

7. Houpt M., Project USAP 2000--use of sedative agents by pediatric dentists: a 15-year 755 follow-up survey. Pediatr Dent. 2002;24:289-294. 756

8. Houpt M.I., Project USAP--Part III: Practice by heavy users of sedation in pediatric 757 dentistry. ASDC J Dent Child, 1993;60:183-185. 758

9. Silver T, Wilson C, Webb M. Evaluation of two dosages of oral midazolam as a 759 conscious sedation for physically and neurologically compromised pediatric 760 dental patients. Pediatr Dent, 1994;16:350-359. 761

10. Wilson S, Easton J, Lamb K, Orchardson R, Casamassimo P. A retrospective study of 762 chloral hydrate, meperidine, hydroxyzine, and midazolam regimens used to 763 sedate children for dental care. Pediatr Dent, 2000;22:107-112. 764

11. Wilson S. Pharmacologic behavior management for pediatric dental treatment. 765 Pediatr Clin North Am, 2000;47:1159-1175. 766


12. ADA, Guidelines for Teaching Comprehensive Control of Anxiety and Pain in 767 Dentistry. 2003 (Adopted ADA HOD October 2003). 768

13. AAPD, Clinical guideline on the use of anesthesia-trained personnel in the provision 769 of general anesthesia/deep sedation to the pediatric dental patient, Pediatr Dent. 770 25(7):82-83. 771

14. AAPD, Policy on the use of deep sedation and general anesthesia in the pediatric 772 dental 773 office, Pediatr Dent. 2004;26(7):xx. 774

15. Committee on Drugs American Academy of Pediatrics. Guidelines for monitoring 775 and management of pediatric patients during and after sedation for diagnostic 776 and therapeutic procedures. Pediatrics 1992;89:1110-1115. 777

16. American Academy of Pediatrics. Guidelines for Monitoring and Management of 778 Pediatric Patients During and After Sedation for Diagnostic and Therapeutic 779 Procedures: Addendum. Pediatrics 2002; 110: 836-838. 780

17. Ingebo KR, Rayhorn NJ, et al. "Sedation in children: adequacy of two-hour fasting." 781 J Pediatr 1997;131:155-158. 782

18. Coté CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation 783 events in pediatrics: A critical incident analysis of contributory factors. Pediatrics 784 2000;105:805-814. 785

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