Guidelines for Administration of Moderate Sedation

PURPOSE: This rule provides for the requirements and guidelines dentists are required to follow in the administration of sedative drugs. (1) Introduction. (A) These guidelines are provided to certificate holders in the administration of enteral or parenteral moderate sedation. (B) Implicit in the administration of sedative drugs is the dictum that they be used in a safe and effective manner. (C) The goals of moderate sedation are— 1. Sufficient control of patient behavior to enable the practitioner to provide quality treatment; 2. Prompt recovery so that the patient leaves the office in a state of consciousness as close to normal for that patient as possible; and 3. Promotion of a positive psychological response to treatment. (2) Patient Records. (A) The patient’s record shall provide a legible database that aids in treatment planning and selection of the sedation technique and shall furnish the following: 1. Database— A. Full name; B. Address (home and work); C. Telephone number (home and work); D. Date of birth and sex; E. Height and weight; F. Name of parent or guardian, if applicable; G. Name and telephone number of person to notify in event of emergency; and H. Patient’s physician’s name and telephone number; 2. Medical history— A. Chief complaint followed by history of the present illness or a brief statement about the patient’s problem; and B. Past medical history and systems review including, but not limited to: (I) Physician(s) of record; (II) Hospitalizations within the last five (5) years; (III) Allergies; (IV) Present medications (prescription, nonprescription, homeopathic): dosages, intervals, and recent changes; (V) Major medical illnesses, disorders, or abnormalities; (VI) Prior anesthetic complications; (VII) Breathing or respiratory difficulties; (VIII) Previous hospitalizations; and (IX) Review of the following with interrogative clarification of positive responses: (a) Myocardial infarction; (b) Hepatitis or liver disease; (c) Hypertension; (d) Renal disease; (e) Dysrhythmias; (f) Anemia; (g) Angina; (h) Bleeding dyscrasias; (i) Heart murmur; (j) Human immunodeficiency virus (HIV); (k) Congestive heart failure; (l) Mitral valve prolapse; (m) Rheumatic fever; (n) Artificial joint; (o) Diabetes; (p) Neurological/seizure disorders; and (q) Obstructive sleep apnea; and 3. Core physical examination— A. Observation of patient’s physical stature, posture, and relative ambulatory ability; B. Observation of patient’s attentiveness, responsiveness, and verbal ability; C. Oral examination; D. Potential airway problems; E. Baseline blood pressure, heart rate and rhythm, and respiration rate; and F. Temperature—only if necessary for present problem. (3) Pre-Operative Patient Evaluation and (A) Patients who are administered moderate sedation must be suitably evaluated to include, but not be limited to the following: 1. An appropriate review of the patient’s database by the dentist to determine that data pertaining to all of the following are present: A. Patient age; B. Patient weight; C. Individual responsible for informed consent; and D. Emergency contact person and telephone number; 2. An appropriate review of the medical history with opportunity for interrogative clarification by the dentist. The record must indicate that the dentist reviewed the medical history; 3. An appropriate review of the core physical examination. The record must indicate the dentist reviewed the findings; 4. An appropriate review of all medications used by the patient, both prescription and non-prescription. The record must indicate the dentist reviewed the medication inventory; 5. Documented American Society of Anesthesiologists classification; and 6. Documented consultation with physicians of record when indicated. (4) American Society of Anesthesiologists (ASA) classifications must be documented and substantiated. (A) American Society of Anesthesiologists (ASA) classifications: 1. Class I—There is no organic, physiologic, biochemical, or psychiatric disturbance. The pathological process for which the operation is to be performed is localized and is not a systemic disturbance. The patient has no limits on his/her activity level, and in general is to be considered in good or excellent health. 2. Class II—Mild-to-moderate systemic disturbance caused either by the condition to be treated surgically or by other pathophysiological processes. The disease processes are stable or medically controlled and they are not functionally limiting. Examples: tightlycontrolled insulin or non-insulin dependent diabetes; stable asthma; symptomatic hypertension; controlled thyroid disease; smoker; obesity; or severe anxiety. 3. Class III—Severe systemic disturbance or disease from whatever cause, even though it may not be possible to define the degree of disability with finality. Activity is significantly limited by the disease, but is not totally incapacitating. The patient may easily decompensate under stress. Examples: severe asthma; poorly controlled diabetes mellitus; angina, especially if unstable or frequent; status post (S/P) myocardial infarction of cerebral vascular accident (CVA) less than six (6) months ago. 4. Class IV—Indicative of the patient with severe systemic disorder that is a constant threat to life and not always correctable by the operative procedure. Functionally incapacitating; a totally unstable patient who is in and out of lethal states. Examples: unstable angina; congestive heart failure/ chronic obstructive pulmonary disease (CHF/COPD) requiring supplemental oxygen (O2) or wheel-chair confinement, uncontrolled systemic disease (diabetes mellitus); or symptomatic dysrhythmias. 5. Class V—The moribund patient who has little chance of survival but is submitted to operation in desperation. A hospitalized patient of the expectant category. (B) Healthy or medically stable individuals (ASA Class I or II) require a review of the patient’s current medical history and medications. (C) ASA III, IV, and V patients are not candidates for enteral moderate sedation. (D) ASA III, IV, and V patients are not candidates for parenteral moderate sedation outside a hospital setting. (5) Informed Consent. (A) Appropriate informed consent must be obtained prior to administration of enteral or parenteral moderate sedation. (B) All of the following requirements for informed consent must be satisfied and documented prior to administration of moderate sedation: 1. The patient and/or guardian must be advised of the specific procedure inducing enteral, parenteral, or pediatric moderate sedation; 2. The patient and/or guardian must be advised of the risks associated with the delivery of enteral, parenteral, or pediatric moderate sedation; 3. The patient and/or guardian must be advised of the options to the delivery of the enteral, parenteral, or pediatric moderate sedation; 4. The patient and/or guardian must be advised that moderate sedatives given by the enteral route must not exceed one and onehalf (1.5) times the maximum recommended dose (MRD); 5. The patient and/or the guardian must be advised that unforeseen circumstances can occur and the dentist and the sedation team need permission in advance to change the plan of treatment if it is deemed in their professional judgment to be in the best interest of the patient; 6. The patient and/or guardian must be afforded the opportunity to have concerns and questions addressed by the dentist; and 7. The patient and/or guardian’s consent must be documented. (C) Refer to section (16) for a sample conscious sedation informed consent. (6) Sedation Documentation Requirements. (A) A time oriented anesthesia record must be documented including the dosage and administration of drugs and physiologic data obtained during patient monitoring. (B) At a minimum, the anesthetic record must contain the following: 1. Names of the qualified sedation provider and sedation team members (dentist, anesthetist, assistants); 2. Date; 3. Documentation of nothing by mouth; 4. Vital signs recorded (blood pressure, pulse rate, and percent of O2 saturation): A. Preoperatively; B. After delivery of initial medications (to include the local anesthesia); and C. At a minimum every fifteen (15) minutes throughout the procedure; 5. Start and finish times for the anesthesia procedure and the operative procedure; 6. Agents delivered (name, dosage, route of administration, and flow rates); 7. Local anesthetics; 8. Inhalation agents; 9. Sedatives; 10. When medications are prescribed or dispensed, a copy of the prescription or a notation describing the medication should be in the patient’s chart with the instructions for use; 11. Complications or unusual reactions (all pertinent data, vital signs, and/or medications, etc.); and 12. Discharge status. (C) Monitoring data must be documented by qualified personnel capable of physical assessment of a sedated patient. (7) Monitoring Procedures. (A) Moderate sedation patients shall be monitored under the direct and continuous supervision of a sedation team member. (B) For the purpose of supervising and monitoring a moderately sedated patient, members of the sedation team shall be— 1. Capable of physical assessment of a sedated patient; 2. Certified in the American Heart Association’s Basic Life Support for the Healthcare Provider (BLS) or an equivalent certification approved by the Missouri Dental Board. Board-approved courses shall meet the American Heart Association guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) and provide written and manikin testing on the course material by an instructor who is physically present with the students. Online only courses will not be accepted to satisfy the BLS requirement or Advanced Cardiopulmonary Life Support (ACLS); 3. Certified in monitoring moderate sedation from a board-approved course provider (certification of non-dentists shall be approved by their respective licensing authorities); and 4. Knowledgeable about medical emergency response incident to the use of enteral, parenteral, and pediatric moderate sedation, including the use of resuscitation equipment and emergency medications. (C) Strict reliance on measuring a single physiologic parameter may be not only misleading but also potentially hazardous. As a rule, no single symptom may be diagnostic of a particular condition, but rather the total patient must be evaluated. (D) Monitoring criteria include: 1. Oxygenation. Color of mucosa, skin or blood shall be continually evaluated. Oxygen saturation must be evaluated continuously by pulse oximetry; 2. Ventilation. Observation of chest excursions and/or auscultation of breath sounds; and 3. Circulation. Record initial blood pressure and pulse and thereafter, as appropriate. (E) Monitoring methods can be divided into mechanical and non-mechanical means. 1. Non-mechanical means shall include: A. Patient and blood color; B. Respiratory rate, depth and rhythm; C. Patient’s response to verbal conversation is an excellent gauge to depth of sedation. Is it quick, appropriate, and clear, or is it difficult to obtain, inappropriate and markedly slurred; D. Body posturing; and E. Skin status. 2. Mechanical means shall include: A. Blood pressure and pulse rate; B. Pulse oximetry; and C. Pretracheal stethoscope, electrocardiogram (ECG) and temperature monitor, if appropriate. (F) A moderately sedated patient must have direct and continuous supervision and monitoring until oxygenation, respiration, and circulation are stable and the patient is appropriately responsive for discharge from the facility. (8) Discharge Assessment and Procedures. (A) The final responsibility for determining whether a patient is appropriately responsive and stable for discharge rests solely with the dentist. This may be done in consultation with a certified registered nurse anesthetist or an anesthesiologist. (B) Patients who have unusual reactions to enteral, parenteral, or pediatric moderate sedation shall be assisted and monitored until stable for discharge. Recovery must be documented. (C) The patient must be continually monitored during the recovery period and discharged only when the following criteria are met: 1. Cardiovascular function is satisfactory and stable; 2. Airway patency is uncompromised and satisfactory; 3. Patient is easily arousable and protective reflexes intact; 4. Patient’s state of hydration is adequate; 5. Patient can verbalize appropriately; 6. Patient can sit unaided; 7. Patient can ambulate with minimal precautionary assistance; 8. For a very young child or disabled patient, the pre-sedated level of responsiveness should be achieved; 9. Patients receiving reversal agents may only be discharged after a two- (2-) hour observation period from the last dose of reversal agent and must meet the usual discharge criteria; 10. Appropriate post-discharge supervision is confirmed; and 11. Written post-operative instructions reviewed with and signed by the individual responsible for post-discharge supervision. (9) Personnel. (A) The minimum number of individuals available to support a sedated patient shall be three (3): the dentist and two (2) members of the sedation team, which may include a certified registered nurse anesthetist or an anesthesiologist. (B) All individuals that may be called upon to be responsible for supervising and monitoring sedated patients shall be qualified as set forth in (7)(B). (10) Facilities and Equipment. (A) Access and egress to the dental facility and the operatories used for moderate sedation shall meet the requirements of the Americans with Disabilities Act (ADA) and allow access for emergency medical personnel and equipment. (B) The operatory should be large enough to permit personnel to move freely about the patient. Monitors shall be positioned for easy visualization. (C) The operating table or dental chair should be positioned to permit personnel to maintain the airway, allow quick alteration of patient position, provide a firm platform for the management of cardiopulmonary resuscitation, and provide access to the patient’s oral cavity. (D) The recovery area, whether the operatory or a separate area, shall allow continuous patient visualization by personnel and have sufficient room to treat any emergency. Further, it shall be equipped with systems to allow appropriate monitoring, for providing oxygen under pressure and suction, and provide adequate lighting and electrical outlets. (E) Equipment shall include: 1. A suction system allowing tonsillar (enteral sedation) and catheter suction (parenteral sedation); 2. A positive pressure oxygen delivery system accommodating both adult and pediatric patients (if pediatric patients are treated); 3. Inhalation anesthetic systems coded to prevent accidental administration of the wrong gas and equipped with a fail-safe mechanism; 4. A portable oxygen unit with appropriate accessories; 5. A pulse oximetry monitor; 6. A defibrillator (an automatic defibrillator is recommended). (F) An electrocardiograph is recommended equipment if the primary administrator of enteral and/or parenteral moderate sedation is competent in its use and interpretation. (G) Backup systems shall include: 1. A protocol for obtaining emergency assistance; 2. Battery-powered lighting of sufficient intensity to complete any procedure; and 3. Backup suction sufficient to complete any procedure. (11) Resuscitation Equipment. (A) An emergency kit should be readily accessible and portable. It should contain drugs and equipment of appropriate sizes to resuscitate a non-breathing, unconscious patient who may also be suffering varying degrees of cardiovascular collapse to sustain life until responsibility for the patient’s care is assumed by appropriate medical personnel (e.g., emergency medical technicians (EMTs), physician, emergency room personnel). (B) Resuscitation equipment shall be immediately accessible and appropriate for the route of administration of the permit holder. (C) All moderate sedation permit holders should have immediate access to— 1. Airway and ventilation equipment— A. Oxygen; B. Full face masks of appropriate sizes to accommodate all sedated patients; C. Mechanism to deliver O2 with positive pressure; D. Equipment for performing an emergency cricothyroidotomy; and E. Nasopharyngeal and oral airways; 2. Tonsillar suction; 3. Syringes and needles for intravenous (I.V.) drug administration; and 4. Unexpired medications as set forth in section (15). (D) In addition, parenteral moderate sedation permit holders should have immediate access to— 1. I.V. solutions and equipment for establishment of an I.V. route, and appropriate fluids; 2. Sterile diluent for injection and/or mixing or dilution of drugs; 3. Catheter suction; and 4. Syringes and needles for I.V. drug administration. (12) Site Certificate. (A) No facility shall be the site for the administration of enteral and/or parenteral moderate sedation without being issued a site certificate pursuant to 20 CSR 2110-4.020. (B) The board may require a facility requesting a site certificate for moderate sedation undergo a facility inspection. Facility inspections will be conducted by boardappointed consultants. A facility inspection will be deemed satisfactory when all criteria in subsections (12)(C) and (D) of this rule have been satisfactorily met. 1. All parenteral and pediatric moderate sedation permit applicants shall receive an on-site evaluation. 2. Enteral moderate sedation permit applicants may receive an on-site evaluation. 3. The board may, at any time, inspect a facility where moderate sedation is administered in order to verify compliance with the minimum requirements of the moderate sedation rule. (C) The facility shall be properly maintained and equipped. The dentist-in-charge shall verify via notarized affidavit the following exists and is in good working order: 1. Adequate access and egress for emergency medical personnel to dental facility and operatories used for sedation; 2. Operatory and recovery room design enables appropriate monitoring and emergency response; 3. Emergency kit is accessible, portable, and contains drugs and equipment of appropriate sizes to resuscitate a non-breathing, unconscious patient; 4. Positive pressure oxygen and appropriate face masks; 5. Portable oxygen; 6. Tonsillar vacuum; 7. Pulse oximetry; 8. Pretracheal stethoscope; 9. Nasopharyngeal and oral airways; 10. Battery-powered lighting of sufficient intensity to complete any procedure; 11. Backup suction to complete any procedure; and 12. Defibrillator. (D) Sedation team members shall be capable of safely executing procedures associated with enteral and/or parenteral and pediatric moderate sedation. The dentist-in-charge shall verify the following via notarized affidavit: 1. The primary administrator of enteral, parenteral, or pediatric moderate sedation is a qualified sedation provider as defined in subsection (1)(CC) of 20 CSR 2110-4.010 who maintains current certification and licensure in their field of practice; 2. Appropriate patient records are maintained as set forth in section (2) of this rule; 3. Appropriate patient selection criteria are employed as set forth in sections (3) and (4) of this rule. The dentist-in-charge and permitted dentists should be prepared to demonstrate knowledge of physical evaluation of patients, American Society of Anesthesiologists (ASA) classifications, and their application to appropriate patient selection; 4. Appropriate informed consent is utilized as set forth in section (5) of this rule; 5. Time oriented anesthesia records are appropriately maintained as set forth in section (6) of this rule; 6. Direct and continuous monitoring of sedated patients is accomplished by sedation team members through recovery until discharge as set forth in section (7) of this rule; 7. Appropriate documentation occurs for the management and treatment of sedated patients; and 8. Appropriate criteria are in place to determine when a patient can be safely discharged and appropriate post-operative instructions are given to responsible individuals who will supervise the sedated patient after discharge as set forth in section (8) of this rule. (E) The sedation team shall be capable of responding to emergencies incident to the administration of enteral, parenteral, or pediatric moderate sedation. The sedation team should be prepared for the following emergencies and be competent in simulated responses: 1. General emergency response protocol; 2. Laryngospasm; 3. Acute airway obstruction; 4. Cardiopulmonary arrest; 5. Allergic reaction to drugs; 6. Hypotension; 7. Angina pectoris; 8. Possible myocardial infarction; 9. Emesis and aspiration of vomitus; and 10. Convulsions. (13) Board-Approved Courses. (A) A course satisfying the educational requirements for an enteral moderate sedation permit shall include, but not be limited to: 1. Appropriate definitions; 2. Appropriate patient records; 3. Review of history and physical evaluation; 4. ASA classification; 5. Indications for medical consultations; 6. Appropriate patient selection; 7. Properly maintained and equipped facilities; 8. Informed consent; 9. Pharmacological review of common sedatives and reversal agents; 10. Incremental dosing techniques not to exceed one and one-half (1.5) times the recommended dose of a sedative by the manufacturer. 11. Time oriented anesthesia record; 12. Monitoring and assessment of the sedated patient during treatment and recovery; 13. Appropriate documentation of the management and treatment of sedated patients; 14. Appropriate discharge criteria; 15. Post-sedation instructions; 16. Response to most common emergencies incident to administration of moderate sedation; 17. A minimum of ten (10) sedation experiences with direct clinical experience on a minimum of three (3) patients in a group of dentists/students no greater than five (5); 18. Simulated experience with an overly sedated patient and how to rescue that patient until they recover; 19. Drug Enforcement Administration (DEA) record keeping; and 20. Pass an independent examination such as the American Dental Society of Anesthesiology (ADSA) moderate sedation fellowship exam or other board-approved test measuring knowledge required of a dentist essential for safe and efficient moderate sedation of dental patients. (B) The sedation monitoring course content shall include, but not be limited to: 1. Appropriate definitions; 2. Appropriate patient records; 3. Basic pharmacology, including but not limited to drug interactions with sedatives; 4. Basic anatomy and physiology as it pertains to the sedated patient; 5. Reviewing patient records for essential data and screening medical histories; 6. ASA classification and appropriate patient selection; 7. Properly maintained and equipped facilities; 8. Informed consent; 9. Time oriented anesthesia record; 10. Monitoring and assessment of the sedated patient during treatment and recovery; 11. Appropriate documentation of the management and treatment of sedated patients; 12. Appropriate discharge criteria; 13. DEA record keeping; 14. Auxiliary roles in response to most common emergencies incident to administration of moderate sedation; and 15. An examination measuring knowledge necessary for safe, effective monitoring of a sedated dental patient. (14) References. (A) Office Anesthesia Evaluation Manual American Association of Oral and Maxillofacial Surgeons 9700 West Bryn Mawr Ave Rosemont, IL 60018 (B) American Dental Association Guide- lines for the Use of Sedation and General Anesthesia by Dentists as adopted by the October 2007 ADA House of Delegates, American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611-2678. (15) Emergency Drugs. (A) Minimum required emergency drugs for enteral sedation. 1. Ammonia carpules; 2. Antihistamines; 3. Benzodiazepine antagonist; 4. Bronchodilator inhaler; 5. Concentrated glucose fifty percent (50%), (cake icing, candy, orange juice); 6. Epinephrine (1:1,000 at a minimum); and 7. Nitroglycerin. (B) Minimum required emergency drugs for parenteral sedation. 1. Ammonia carpules; 2. Antihistamines; 3. Atropine (or related drugs); 4. Benzodiazepine antagonist; 5. Bronchodilator inhaler; 6. Concentrated glucose fifty percent (50%), (cake icing, candy, orange juice); 7. Corticosteroid; 8. Epinephrine (1:1,000 at a minimum); 9. Narcotic antagonist; and 10. Nitroglycerin. (C) Suggested but not required emergency drugs. 1. Aminophylline; 2. Hyperstat or Labetalol (or related drugs); 3. Lidocaine (one hundred (100) mg injectables); 4. Sodium bicarbonate; and 5. Succinylcholine chloride. (16) Sample Informed Consent for Moderate Sedation. The purpose of this document is to provide an opportunity for patients to understand and give permission for moderate sedation when provided along with dental treatment. Each item should be checked off after the patient has the opportunity for discussion and questions. ________1. I understand that the purpose of moderate sedation is to more comfortably receive necessary care. Moderate sedation is not required to provide the necessary dental care. (See #4 options.) ________2. I understand that moderate sedation is a drug-induced state of reduced awareness and decreased ability to respond. Moderate sedation is not sleep from which I can be easily awakened. My ability to respond normally returns when the effects of the sedative wear off. ________3. I understand that my moderate sedation will be achieved by the following route: ________Oral Administration: I will take a pill approximately _______ minutes before my appointment. The sedation will last approximately to hours. Patients like oral sedation because they do not need an “I.V.” line. However the level of sedation is less predictable than with “I.V.” sedation. ________Intravenous (I.V.) Administration: The anesthesia provider will inject the sedative. The length of sedation may be shorter and the level more predictable than with oral sedation. The I.V. sedation will last approximately ____ to ________ hours. ________4. I understand that the options to moderate sedation are: a. No sedation: The necessary procedure is performed under local anesthetic with the patient fully aware. b. Nitrous oxide sedation: Commonly called laughing gas, nitrous oxide provides relaxation but the patient is still generally aware of surrounding activities. Its effects can be reversed in five (5) minutes with oxygen. c. General anesthetic: Commonly called deep sedation, a patient under general anesthetic has no awareness and must have their breathing temporarily supported. General anesthesia is more appropriate for longer procedures lasting three (3) or more hours. ________5. I understand that there are risks or limitations to all procedures. For sedation these include: ________(Oral Sedation) Inadequate sedation with initial dosage may require the patient to undergo the procedure without full sedation or delay the procedure for another time. Due to unpredictable patient response, it is not recommended that oral sedatives be given in successive or additive doses. ________An atypical reaction to sedative drugs that may require emergency medical attention and/or hospitalization. ________Inability to discuss treatment options with the doctor should the circumstance require a change in treatment plan. ________6. If, during the procedure, a change in treatment is required, I authorize the dentist and the sedation team to make whatever change they deem in their professional judgment is necessary. ________7. I have had the opportunity to discuss moderate sedation and have my questions answered by sedation team members including the dentist, if I so desire. ________8. I hereby consent to moderate sedation in conjunction with my dental care. ________________ __________ _________ Patient/Guardian Date Witness AUTHORITY: sections 332.031 and 332.361, RSMo 2000, and section 332.071, RSMo Supp. 2012.* This rule originally filed as 4 CSR 110-4.030. Original rule filed Sept. 15, 2004, effective April 30, 2005. Moved to 20 CSR 2110-4.030, effective Aug. 28, 2006. Amended: Filed July 26, 2012, effective Feb. 28, 2013. *Original authority: 332.031, RSMo 1969, amended 1981, 1993, 1995; 332.071, RSMo 1969, amended 1976, 1995, 2003, 2004, 2006; and 332.361, RSMo 1969, amended 1981.