Update on Oral Sedation Regs: October 13. 2011
TX, IL, MO, MS, OK, FL, WI, NM
TEXAS: (as of June 1, 2011)
RULE §110.1
Definitions
(15) Maximum recommended dose (applies to minimal sedation)--FDA maximum
recommended dose (MRD) of a drug, as printed in FDA-approved labeling for unmonitored
home use.
(16) Minimal sedation--a minimally depressed level of consciousness, produced by a
pharmacological method, which 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. Medication administered for the purpose of minimal
sedation shall not exceed the maximum doses recommended by the drug manufacturer.
Nitrous oxide/oxygen may be used in combination with a single enteral drug in minimal
sedation. During longer periods of minimal sedation in which the total amount of time of the
procedures exceeds the effective duration of the sedative effect of the drug used, the
supplemental dose of the sedative shall not exceed total safe dosage levels based on the
effective half-life of the drug used. The total aggregate dose must not exceed one and onehalf times the MRD on the day of treatment. The use of prescribed, previsit sedatives for
children aged twelve (12) or younger should be avoided due to the risk of unobserved
respiratory obstruction during the transport by untrained individuals.
(17) Moderate sedation--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. A Level 2 permit is
required for moderate sedation limited to enteral routes of administration. A Level 3 permit is
required for moderate sedation including parenteral routes of administration. In accordance
with this particular definition, the drugs or techniques used shall carry a margin of safety wide
enough to render unintended loss of consciousness unlikely. Repeated dosing of an agent
before the effects of previous dosing can be fully appreciated may result in a greater
alteration of the state of consciousness than is the intent of the dentist. A patient whose only
response is reflex withdrawal from a painful stimulus is not considered to be in a state of
moderate sedation.
Nitrous Oxide/Oxygen Inhalation Conscious Sedation
Level 1:
Minimal Sedation --
(Nitrous Plus One
Enteral Drug)
Level 2:
Moderate Enteral --
(Limited to Enteral
Routes of
Administration)
Level 3:
Moderate Parenteral --
(Limited to
Parenteral Routes of
Administration)
Level 4:
Deep Sedation/General Anesthesia
Nitrous Oxide training = 14 hrs, Minimal Sedation training = 16 hrs. You can apply for one or the other,
if you get the minimal sedation permit it allows for nitrous plus one enteral drug.
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RULE §110.4
Minimal Sedation
a) Education and Professional Requirements. A dentist applying for a Level 1 Minimal Sedation permit shall meet one
of the following educational/professional criteria:
(1) satisfactory completion of training to the level of competency in minimal sedation consistent with that
prescribed in the American Dental Association (ADA) Guidelines for Teaching Pain Control and Sedation to Dentists
and Dental Students, or a comprehensive training program in minimal sedation that satisfies the requirements
described in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. This
includes a minimum of sixteen (16) hours of didactic training and instruction in which competency in enteral and/or
combined inhalation-enteral minimal sedation technique is demonstrated; or
(2) satisfactory completion of an advanced education program accredited by the ADA Commission on Dental
Accreditation (CODA) that affords comprehensive training necessary to administer and manage minimal sedation,
commensurate with the ADA's Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students; or
(3) is a Texas licensed dentist, has a current Board-issued enteral permit, and has been using minimal sedation in a
competent manner immediately prior to the implementation of this chapter on June 1, 2011. Any Texas licensed
dentist who was issued an enteral sedation permit before June 1, 2011 and whose enteral sedation permit was active
on June 1, 2011 shall automatically have the permit reclassified as a Level 1 Minimal Sedation permit on June 1,
2011. A Texas licensed dentist whose permit is reclassified from an enteral sedation permit to a Level 1 Minimal
Sedation permit on June 1, 2011 may continue to administer enteral sedation until January 1, 2013. On or before
January 1, 2013, the 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. A dentist shall always follow the standard of care and clinical requirements for the level of sedation
he or she is performing.
ILLINOIS:
Section 1220.505 Minimal Sedation (Anxiolysis) in the Dental Office Setting
a)
Minimal sedation (anxiolysis) includes the prescription or administration of a
pharmacologic anxiolytic either with or without concomitant use of nitrous oxide
dental analgesia. The drugs and/or techniques used must carry a margin of safety
wide enough to prevent a depressed level of consciousness.
b)
No permit is required beyond the D.D.S. or D.M.D. degrees.
c)
Minimal monitoring of the patient is to be by clinical observation and
appropriately documented in the patient's record.
(Source: Amended at 34 Ill. Reg. 7205, effective May 5, 2010)
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MISSOURI:
20 CSR 2110-4.010 Definitions
(B) Anxiolysis—the diminution or elimination of anxiety. Anxiolysis is not conscious sedation.
(C) Conscious sedation—a minimally depressed level of consciousness that retains the patient’s ability to
independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal
command, and that is produced by a pharmacologic or non-pharmacologic method, or a combination thereof.
Conscious sedation is not deep sedation or general anesthesia.
20 CSR 2110-4.020 Conscious Sedation
(1) No dentist shall administer enteral and/or parenteral conscious sedation unless the dentist possesses a
conscious sedation permit issued by the Missouri Dental Board. (A dentist is not required to possess a permit for
the prescription or administration of drugs prescribed for anxiolysis and/or pain control.) This permit shall be renewed
by June 1 every five (5) years from the year of issuance.
(2) No dentist shall prescribe sedative agents for enteral sedation unless the dentist possesses an enteral or
parenteral conscious sedation permit issued by the Missouri Dental Board. No dentist shall prescribe parenteral
conscious sedation agents unless the dentist possesses a parenteral conscious sedation permit issued by the
Missouri Dental Board.
MISSISSIPPI:
BOARD REGULATION NUMBER 29--ADMINISTRATION OF ANESTHESIA
1. Definitions of Terminology Used Herein
a. Analgesia - the diminution or elimination of pain.
b. Anti-Anxiety Sedative - a sedative agent administered in a dosage intended to reduce anxiety without diminishing
consciousness or protective reflexes.
c. Anxiolysis (Minimal Sedation) - pharmacological reduction of anxiety through the administration of a minor
tranquilizer, which allows for uninterrupted interactive ability in a totally awake patient with no compromise in the
ability to maintain a patent airway continuously and without assistance. The total dosage cannot exceed 1.5 MRD
(maximum recommended dosage).
d. Behavioral Management - the use of pharmacological or psychological techniques, singly or in combination, to
modify behavior to a level that dental treatment can be performed effectively and efficiently.
3. Board Permits Not Required. For the following, Board permits are not required:
a. Local Anesthesia. All licensed dentists are herein authorized to use local anesthesia.
b. Nitrous-Oxide Inhalation Anxiolysis. A licensed dentist may employ or use nitrous-oxide inhalation anxiolysis on an
outpatient basis for dental patients without making application to the Board, provided such dentist satisfies one
or more of the following criteria prior to administration of nitrous-oxide inhalation anxiolysis:
(1) Completion of not less than a two-day course of training as described in the American Dental Association's
(hereinafter referred to as “ADA”) "Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in
Dentistry," or its equivalent.
(2) Completion of training equivalent to that described above while a student in an ADA-accredited undergraduate
dental school program. A licensed dentist may instruct a competent dental auxiliary as to the placement and
monitoring of nitrous-oxide inhalation anxiolysis under his/her direct supervision, such supervision as defined in
Board Regulation 13.
c. Combination Inhalation Enteral Anxiolysis. A licensed dentist may employ or use combination inhalation enteral
anxiolysis on an outpatient basis for dental patients without making application to the Board, i.e., the use of nitrousoxide in combination with other agents to produce anxiolysis within appropriate dosages.
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OKLAHOMA:
195:20-1-7. Minimal standards for dentists utilizing enteral conscious sedation (oral, rectal, sublingual)
(a) Every dentist who utilizes enteral conscious sedation (oral, rectal, sublingual) shall be responsible for all aspects
of the procedure as outlined in Part I, Section V of the American Dental Association Guidelines for the Use of
Conscious Sedation, Deep Sedation and General Anesthesia for Dentists. This shall include careful patient
evaluation and informed consent prior to the start of any sedation procedure. Continuous monitoring of oxygenation,
ventilation, and circulation with documentation of all procedures, drugs, and agents on an appropriate time-oriented
anesthesia record shall be completed or each patient. The dentist performing the sedation is required to be in the
patient’s presence at all times during the procedure. No provider shall have more than one (1) patient under any
form of sedation at the same time, exclusive of recovery. Supervised recovery and complete evaluation of the patient
prior to discharge to a responsible adult is required. Minimal monitoring equipment shall include blood pressure
apparatus (manual or automatic) and a pulse oximeter.
(b) The anesthesia provider is responsible for the anesthetic management, adequacy of the facility, and treatment of
emergencies associated with administration of enteral conscious sedation, including immediate
access to pharmacologic antagonists, if any, and appropriately sized equipment for establishing a patent airway and
providing positive pressure ventilation with oxygen.
No permit is required for minimal enteral sedation or moderate enteral sedation at this time.
FLORIDA:
64B5-14.001 Definitions.
(10) Minimal Sedation (anxiolysis) – The perioperative use of medication to relieve anxiety before or during a
dental procedure which does not produce a depressed level of consciousness and maintains the patient’s ability to
maintain an airway independently and to respond appropriately to physical and verbal stimulation. This minimal
sedation shall include the administration of a single enteral sedative or a single narcotic analgesic medication
administered in doses appropriate for the unsupervised treatment of anxiety and pain. If clinically indicated, an
opioid analgesic may also be administered during or following a procedure if needed for the treatment of pain.
Except in extremely unusual circumstances, the cumulative dose shall not exceed the maximum recommended
dose (as per the manufacturers recommendation). It is understood that even at appropriate doses a patient may
occasionally drift into a state that is deeper than minimal sedation. As long as the intent was minimal sedation and
all of the above guidelines were observed, this shall not automatically constitute a violation. A permit shall not be
required for the perioperative use of medication for the purpose of providing anxiolysis.
(11) Titration of Oral Medication – The administration of small incremental doses of an orally administered
medication until an intended level of conscious sedation is observed.
64B5-14.003 Training, Education, Certification, and Requirements for Issuance of Permits.
(4) Nitrous-Oxide Inhalation Analgesia.
(a) A dentist may employ or use nitrous-oxide inhalation analgesia on an outpatient basis for dental patients
provided such dentist:
1. Has completed no less than a two-day course of training as described in the American Dental Association’s
“Guidelines for Teaching and Comprehensive Control of Pain and Anxiety in Dentistry” or its equivalent; or
2. Has training equivalent to that described above while a student in an accredited school of dentistry; and
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3. Has adequate equipment with fail-safe features and a 25% minimum oxygen flow.
(b) A dentist utilizing nitrous-oxide inhalation analgesia and such dentist’s assistant/dental hygienist personnel
shall be certified in an American Heart Association or American Red Cross or equivalent Agency sponsored
cardiopulmonary resuscitation course at the basic life support level to include one man CPR, two man CPR,
infant resuscitation and obstructed airway with a periodic update not to exceed two years. Starting with the
licensure biennium commencing on March of 2000, a dentist and all assistant/dental hygienist personnel shall
also be trained in the use of either an Automated External Defibrillator or a defibrillator and
electrocardiograph as part of their cardiopulmonary resuscitation course at the basic life support level. In
addition to CPR certification, a dentist utilizing pediatric conscious sedation must be currently trained in ACLS
(Advanced Cardiac Life Support), ATLS (Advanced Trauma Life Support), or PALS (Pediatric Advanced Life
Support).
(c) A dentist who regularly and routinely utilized nitrous-oxide inhalation analgesia on an outpatient basis in a
competent and efficient manner for the three-year period preceding January 1, 1986, but has not had the
benefit of formal training outlined in subparagraphs 1. and 2. of paragraph (4)(a) above, may continue such
use provided the dentist fulfills the provisions set forth in paragraph 3. of paragraph (4)(a) and the provisions
of paragraph (b) above.
(d) Nitrous oxide may be used in combination with a single dose enteral sedative or a single dose narcotic
analgesic to achieve a minimally depressed level of consciousness so long as the manufacturer’s maximum
recommended dosage of the enteral agent is not exceeded. Nitrous oxide may not be used in combination
with more than one (1) enteral agent, or by dosing a single enteral agent in excess of the manufacturer’s
maximum recommended dosage unless the administering dentist holds a conscious sedation permit issued in
accordance with subsection
WISCONSIN:
DE 11.02 Definitions. In this chapter,
(1) “Analgesia” means the diminution or elimination of pain in a conscious patient.
(1m) “Anxiolysis” means the use of medication to relieve anxiety before or during a dental procedure which
produces a minimally depressed level of consciousness, during which the patient’s eyes are open and the patient
retains the ability to maintain an airway independently and to respond appropriately to physical and verbal
command.
(2) “Conscious sedation” means a depressed level of consciousness during which the patient mimics
physiological sleep, has vitals that are not different from that of sleep, has his or her
eyes closed most of the time while still retaining the ability to independently and continuously maintain an
airway and respond appropriately to physical stimulation and verbal command, produced by a pharmacologic or
non−pharmacologic method, or a combination of pharmacologic and non−pharmacologic methods.
DE 11.03 Requirements for nitrous oxide inhalation.
(1) A dentist may use nitrous oxide inhalation on an outpatient basis for dental patients provided that he or she
has adequate equipment with failsafe features and a 25% minimum oxygen
flow.
(2) A dentist utilizing nitrous oxide inhalation shall be trained and certified in administering basic life support.
This certification shall be renewed in compliance with the standards set forth by the American Heart
Association, the American Red Cross, or other organization approved by the board.
History: CR 04−095: cr. Register August 2006 No. 608, eff. 1−1−07.
DE 11.04 Requirements for anxiolysis. A dentist utilizing anxiolysis shall be trained and certified in administering
basic life support. This certification shall be renewed in compliance with the standards set forth by the
American Heart Association, the American Red Cross, or any other organization
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approved by the board.
History: CR 04−095: cr. Register August 2006 No. 608, eff. 1−1−07.
DE 11.05 Requirements for conscious sedation–enteral.
(1) Beginning on January 1, 2007, no dentist may administer conscious sedation via an enteral route without
having first obtained a class one permit from the board, unless a dentist has been granted a permit under s.
DE 11.06 or 11.07. A class one permit enables a dentist to utilize conscious sedation enterally.
NEW MEXICO:
16.5.15.7
DEFINITIONS:
A.
"Conscious sedation" means a minimally depressed level of consciousness that retains the patients
ability to independently and continuously maintain an airway and respond appropriately to physical
stimulation and verbal command. Conscious sedation is produced by a pharmacologic or nonpharmacologic method or combination thereof. In accord with this particular definition, the drugs and/or
techniques used should carry a margin of safety wide enough to render unintended loss of consciousness
unlikely. Further, patients whose only response is reflex withdrawal from repeated painful stimuli would
be considered to be in a deeper state of anesthesia than conscious sedation.
B.
"Deep sedation" means a induced state of depressed consciousness accompanied by partial loss of
protective reflexes, including the inability to continually maintain an airway independently and/or to
respond purposefully to verbal command. Deep sedation is produced by a pharmacologic or nonpharmacologic method or combination thereof.
C.
"General anesthesia" means a induced state of unconsciousness, accompanied by partial or
complete loss of protective reflexes, including the inability to continually maintain an airway independently
and respond purposefully to physical stimulation or verbal command. General anesthesia is produced by a
pharmacologic or non-pharmacologic method or combination thereof.
D.
"Monitor" means to watch or check on.
E.
"Nitrous oxide inhalation analgesia" means the administration by inhalation of a combination of
nitrous oxide and oxygen, producing an altered level of consciousness that retains the patient's ability to
independently and continuously maintain an airway and respond appropriately to physical stimulation or
verbal command.
F.
"Prescribed administration" means the nitrous oxide is administered by a dental hygienist or dental
assistant under the indirect supervision of the dentist with the dentist's authorization.
G.
"Combination inhalation-enteral sedation (combined conscious sedation)" - conscious sedation
using inhalation and enteral agents. Nitrous oxide/oxygen when used in combination with sedative agents
may produce anxiolysis, conscious or deep sedation or general anesthesia.
H.
“Anxiolysis” the diminution or elimination or reduction of anxiety.
I.
“Enteral” means any technique of administration in which the agent is absorbed through the
gastrointestinal tract or oral mucosa. (ie oral, rectal, sublingual)
16.5.15.10
ADMINISTRATION OF NITROUS OXIDE OR ENTERAL ANXIOLYSIS (MINIMAL
SEDATION) ANALGESIA:
A.
NITROUS OXIDE:
(1) Registration required: Each licensed dentist who administers or supervises the prescribed
administration of nitrous oxide inhalation analgesia shall be registered with the board. A registration form
will be provided upon initial application or upon request, and contain information to verify the dentist,
facility, and staff meet the requirements specified in Paragraph (2) of Subsection A of 16.5.15.10 NMAC.
When the registration has been approved by the secretary-treasurer of the board the applicant will be sent a
wall certificate which does not expire. Administration of nitrous oxide inhalation analgesia without
registration is a violation of these rules and may result in disciplinary action against the licensee.
(2) Requirements for registration: Each licensed dentist who administers or prescribes administration
of nitrous oxide inhalation analgesia shall meet the following requirements:
(a) completed a course of training leading to competency while a student in an accredited
school of dentistry or through postgraduate training;
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(b) have adequate equipment which includes fail-safe features and a 25% minimum oxygen
flow and an effective scavenging system;
(c) each dentist and auxiliary personnel who monitors the use of, or administers nitrous oxide
shall have current basic life support certification;
(d) all use of nitrous oxide inhalation analgesia shall be under the indirect supervision of a
licensed dentist;
(e) the patient's record shall reflect evidence of appropriate monitoring of vital signs, including
blood pressure, pulse, and respiratory rate; and
(f) current permit holders would be grandfathered by New Mexico laws in effect at the time of
original issue of their permit.
B.
ENTERAL ANXIOLYSIS (MINIMAL SEDATION):
(1) Each licensed dentist who holds a nonrestricted DEA license and who administers or supervises
the administration of enteral anxiolytic medication shall be responsible for the following:
(a) completed a course of training while a student in an accredited school of dentistry or
through postgraduate training;
(b) enteral shall be administered only in the office setting and patient shall be monitored;
(c) have adequate equipment to monitor patients vital signs;
(d) each dentist and auxiliary personnel who monitors shall have current basic life certification;
(e) all use of enteral medication shall be under the indirect supervision of a licensed dentist;
(f) the patient's record shall reflect evidence of appropriate monitoring of vital signs, including
blood pressure, pulse, and respiratory rate during procedures and effect of medication;
(g) shall verify the patient has other means of transportation to be released from the office;
(h) administration of enteral anxiolytic medications in doses that do not exceed the normal
therapeutic dosage recommended by the manufacturer in published literature and that are within
the accepted scope of the practice and prescriptive authority of the dentist and does not produce
oral conscious sedation and does not require the dentist to hold a conscious sedation I permit.
[16.5.15.10 NMAC - Rp, 16.5.15.10 NMAC, 3-17-05; A, 07-16-07]
16.5.15.11
ADMINISTRATION OF CONSCIOUS AND DEEP SEDATION: The following three
categories of anesthesia shall not be administered in a dental facility unless the licensed dentist has obtained a permit
from the board. The conscious sedation II and deep sedation/general anesthesia permits are issued to the dentist for
a specific practice location, unless the anesthesia provider holds an anesthesia permit at large. Administration
without a permit is grounds for disciplinary action against the licensee.
A.
Conscious sedation I permit allows a licensed dentist to use only oral or rectal medications or
combined inhalation-enteral conscious sedation to obtain conscious sedation on an outpatient basis for
dental patients.
B.
Conscious sedation II permit allows a licensed dentist to use parenteral injection to obtain
conscious sedation on an outpatient basis for dental patients.
C.
Deep sedation/general anesthesia permit allows a licensed dentist to use deep sedation or general
anesthesia on an outpatient basis for dental patients.
D.
Permit levels: The level of permits in order of increasing complexity are conscious sedation I,
conscious sedation II, and deep sedation/general anesthesia. When a permit is issued for one level, all
levels of lesser complexity are considered within the scope of that permit.
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