2. ENTERAL CONSCIOUS SEDATION CHAPTER 110 Now All Sedation Rules and Regulations Will Be in Chapter 108

3. THAT WE CAN DO AN OFFICE ANESTHETIC DOES NOT MEAN THAT WE MUST

4. Rule 110.1 Definitions… Conscious Sedation –A minimally depressed level of consciousness that retains the pt’s ability to independently and continuously maintain an airway and respond apppro. to physical stimulation and verbal command…

5. Rule 110.1 Definitions… Conscious Sedation –…drugs and/or techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely –…response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of conscious sedation

6. New Definitions—ADA Guidelines Conscious sedation term no longer exists –Minimal –Moderate –Deep –General anesthesia

7. TSBDE Proposed New Rules Five levels of anesthesia and sedation permits –Nitrous Oxide/Oxygen Inhalation Sedation –Level 1—Minimal sedation –Level 2—Moderate Sedation (enteral only) –Level 3—Moderate Sedation (Parenteral sedation) –Level 4—Deep Sedation or General Anesthesia

8. What do the Rule Changes Mean Regarding Permitting? Any dentist with an existing enteral permit prior to date of implementation (6/1/2011) will automatically have the permit reclassified to a Level 1 Minimal Sedation permit on 6/1/2011 Reclassified Level 1 permit holders may continue to administer enteral sedation until 1/1/2013

9. What do the Rule Changes Mean Regarding Permitting? On or before 1/1/2013 dentist shall either provide proof that adequate education has been obtained by submitting an application for a Level 2 permit on or before that date, or shall comply with the requirements of a Level 1 permit after that date.

10. Minimal Sedation “A minimally depressed level of consciousness, produced be a pharmacological method, that retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected.”

11. Minimal Sedation “In accord with this particular definition, the drug(s) and/or techniques used should carry a margin of safety wide enough never to render unintended loss of consciousness. Further, patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of minimal sedation”

12. Minimal Sedation “When the intent is minimal sedation for adults, the appropriate initial dosing of a single enteral drug is no more than the maximum recommended dose (MRD) of a drug that can be prescribed for unmonitored home use.”

13. Minimal Sedation “The use of preoperative sedatives for children (aged 12 and under) except in extraordinary situations must be avoided due to the risk of unobserved respiratory obstruction during transport by untrained individuals”

14. Minimal Sedation “Children (aged 12 and under) can become moderately sedated despite the intended level of minimal sedation; should this occur, the guidelines for moderate sedation apply”

15. Minimal Sedation Supplemental dosing –“During minimal sedation, supplemental dosing is a single additional dose of the initial dose of the initial drug that may be necessary for prolonged procedures. The supplemental dose should not exceed one-half of the initial dose and should not be administered until the dentist has determined the clinical half-life of the initial dosing has passed. The total aggregate dose must not exceed 1.5x the MRD on the day of treatment”

16. Standard of Care Requirements… ….continuous direct supervision of auxiliary personnel… Maintain BLS for the assistant staff No CRNA supervision for a level of sedation that the dentist does not have current permitting

17. Clinical Requirements… Patient Evaluation –ASA I, II Review of their current medical history and medication use –ASA III, IV May require medical consultation with PCP or specialist

18. Clinical Requirements… Pre-Procedure Preparation and Informed Consent –…..must provide written informed consent for the proposed sedation –Adequate oxygen supply –Baseline vital signs must be obtained –Focused physical evaluation must be performed as deemed appropriate –Pre-procedure dietary restriction…. –Pre-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care- giver

19. Clinical Requirements… Monitoring –DDS must remain in the operatory room to monitor the patient until the patient meets criteria for DC. Once the patient meets criteria for DC the DDS may delegate monitoring to a qualified dental auxiliary

20. Clinical Requirements… Monitoring –Oxygenation Color of mucosa, skin or blood must be evaluated continually Oxygen saturation via pulse oximetry should be used when a single drug minimal sedation is performed….with the use of nitrous oxide in combination pulse oximetry must be used –Ventilation DDS or qualified individual must observe chest excursions and must verify respirations continually –Circulation BP an HR should be evaluated pre-, post- and intra-procedurally as necessary

21. Clinical Requirements… Documentation –Names and dosages of all drugs administered and individuals present during administration –Time oriented sedation record may be considered for documentation of all monitoring parameters –SaO 2, HR, RR and BP are the parameters which may be documented at appropriate intervals of no more than 10 minutes

22. Clinical Requirements… Recovery and Discharge –Oxygen and suction immediately available… –DDS must monitor the patient during recovery until the patient is ready for DC by the DDS. May then delegate this task to an appropriately qualified dental auxiliary

23. Clinical Requirements… DDS must determine and document that the patient’s level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge DDS may not leave facility until the patient meets the criteria for discharge and is discharged from the facility

24. Clinical Requirements… Post-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver. Post-procedure patients should be accompanied by and adult caregiver for an appropriate period of recovery. Emergency management Management of children –AAP guidelines for monitoring and management of pediatric patient

25. Moderate Sedation “A drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained”

26. Moderate Sedation …drugs and techniques should carry a margin of safety …repeated dosing may result in a greater alteration of consciousness Withdrawal from only a painful stimulus not considered moderate sedation Titration –Admin of incremental doses of a drug until a desired effect is reached

27. Moderate Sedation Knowledge of each drug’s time of onset, peak response and duration of action is essential to avoid over sedation. Although the concept of titration of a drug to effect is critical for patient safety, when the intent is moderate sedation one must know whether the previous dose has taken full effect before administering an additional drug increment

28. Level 2 Permit.. Educational requirements –BLS documentation –ACLS or PALS or Board approved two-day anesthesia emergency course –Licensees with Level 2 Moderate Sedation permits who provide anesthesia services to children (<12) must document successful completion of PALS course

29. Moderate Sedation… Clinical Requirements –ASA I, II vs. ASA III, IV unchanged –…must provide written informed consent for the proposed sedation –Dietary restriction, baseline vitals, focused physical examination—as per minimal –Pre-procedure verbal or written instruction must be given to the patient, parent, escort, guardian or caregiver

30. Moderate Sedation… Clinical requirements –DDS and at least one other BLS certified individual must be present –Positive pressure oxygen –Nitrous requirements –Equipment necessary to establish intravenous access must be available

31. Moderate Sedation… Monitoring –DDS must remain in the operatory to monitor patient continuously until the patient meets the criteria for recovery –When treatment concludes and the patient recovers to a minimally sedated level, DDS may delegate a qualified dental auxiliary to remain with the patient and continue to monitor until DC

32. Moderate Sedation… Monitoring –Consciousness –Oxygenation Skin color, mucosa or blood Oxygen saturation must be evaluated by pulse oximetry continuously –Ventilation Observation of chest excursions, auscultation of breath sounds, end-tidal CO 2, verbal communication with patient –Circulation BP and HR must be continually evaluated

33. Moderate Sedation… Documentation –Written time-oriented anesthetic record must be maintained and must include names and dosages of all drugs administered and names of individuals present –Pulse oximetry, HR, RR and BP must be continually monitored and documented at appropriate intervals of no more than ten (10) minutes

34. Moderate Sedation… Recovery and Discharge –Oxygen and suction immediately available –While in recovery DDS/qualified staff must continually monitor BP, HR, oxygenation and level of consciousness –DDS must determine and document that the patient’s level of consciousness, oxygenation, ventilation, and circulation are satisfactory for discharge DDS shall not leave facility until DC criteria is met –Post procedural verbal and written instructions must be given to the patient……

35. Moderate Sedation… Recovery and Discharge –If reversal agent is administered before discharge criteria have been met, the patient must be monitored until recovery is assured

36. Moderate Sedation… Emergency Management –The DDS is responsible for the sedation management, adequacy of the facility and staff, diagnosis and treatment of emergencies….providing the equipment and protocols for patient rescue. –Immediate access to pharmacologic antagonists and equipment for establishing a patent airway and providing positive pressure ventilation with oxygen

37. Moderate Sedation… Emergency Management –Advanced airway equipment and resuscitation medications must be available –Defibrillator should be available when ASA I and II patients are sedated under moderate sedation….and must be available when ASA III and IV patients…

38. Continuing Education… ….must complete the following hours of CE biennial on the administration of or medical emergencies associated with the permitted level of sedation –Level 1: Minimal Sedation – six (6) hours –Level 2 and 3: Moderate Sedation – eight (8) hours –Level 4: Deep Sedation/GA – twelve (12) hours Anesthesia CE is in addition to courses required for licensure –ACLS, PALS or Board approved two day emergency course may be used to fulfill the CE requirement when not being taken for the renewal of the permit