(a) Enteral conscious sedation may be induced and maintained
by a permitted dentist licensed by the State of Texas and practicing in Texas,
a physician anesthesiologist licensed by the Texas State Board of Medical
Examiners, or a Certified Registered Nurse Anesthetist (CRNA) licensed in
Texas. When a Certified Registered Nurse Anesthetist (CRNA) is permitted to
function under the supervision of a dentist, in the dental office, provision
of enteral conscious sedation by a CRNA shall require the operating dentist
to be permitted for its utilization.
(b) Enteral conscious sedation is indicated for use only for
conscious sedation as defined in Rule 110.1 of this title (relating to Definitions).
Enteral conscious sedation is not indicated for use to achieve deep sedation.
(c) Administration of nitrous oxide/oxygen inhalation conscious
sedation in combination with enteral administration of any agent, including
minor tranquilizers used for anxiolysis, requires both an enteral conscious
sedation permit and a nitrous oxide/oxygen inhalation conscious sedation permit.
(d) Minor tranquilizers used for anxiolysis may be prescribed
for administration outside of the dental office when pre-procedure instructions
are likely to be followed. Medications such as chloral hydrate and all drugs
included in the Drug Enforcement Administration (DEA) Controlled Substances
Schedule II must not be administered outside of the dental office for sedation
purposes. Medications other than minor tranquilizers used for anxiolysis administered
outside of the office require a permit.
(e) Standard of care requirements. Each dentist must maintain
the minimum standard of care as detailed in board rules, and shall in addition:
(1) adhere to the clinical requirements as detailed in subsection
(f) of this section;
(2) maintain under continuous direct supervision auxiliary
personnel who shall be capable of reasonably assisting in procedures, problems,
and emergencies incident to the use of enteral conscious sedation.
(3) maintain current certification in basic cardiopulmonary
resuscitation for the assistant staff by having them pass a course given by
the American Heart Association or the American Red Cross; and
(4) not allow an enteral conscious sedation procedure to be
performed in his/her office by a Certified Registered Nurse Anesthetist (CRNA)
unless the dentist holds a permit issued by the State Board of Dental Examiners
for the procedure being performed. This provision addresses dentists and is
not intended to address the scope of practice of persons licensed by any other
agency.
(f) Clinical Requirements. Each dentist must meet the following
clinical requirements for utilization of enteral conscious sedation:
(1) Patient Evaluation. Patients who are administered enteral
conscious sedation must be suitably evaluated prior to the start of any sedative
procedure. In healthy or medically stable individuals (ASA I, II), this may
be simply a review of their current medical history and medication use. However,
with individuals who may not be medically stable or who have a significant
health disability (ASA III, IV) consultation with their primary care physician
or consulting medical specialist regarding potential procedure risk is recommended.
(2) Pre-Procedure preparation, informed consent:
(A) the patient and/or guardian must be advised of the procedure
associated with the delivery of the enteral conscious sedation.
(B) equipment must be evaluated and maintained for proper operation.
(C) baseline vital signs should be obtained at the discretion
of the operator depending on the medical status of the patient and the nature
of the procedure to be performed.
(D) dentists administering enteral conscious sedation shall
use sedative agents that he/she is competent to administer and shall administer
such agents is a manner that is within the standard of care.
(g) Personnel and Equipment: In addition to the dentist, at
least one member of the assistant staff should be present during the administration
of enteral conscious sedation.
(h) Monitoring and Documentation:
(1) Patients who have been administered enteral conscious sedation
must be monitored during waiting periods prior to operative procedures. A
responsible adult given appropriate written pre-procedural instruction may
provide such monitoring. The patient should be monitored for alertness, responsiveness,
breathing and skin coloration.
(2) Dentists administering enteral conscious sedation must
maintain direct supervision of the patient during the operative procedure
and for such a period of time necessary to establish pharmacologic and physiologic
vital sign stability.
(A) Oxygenation. Color of mucosa, skin or blood shall be continually
evaluated. Oxygen saturation must be evaluated continuously by pulse oximetry,
except as provided in paragraph (4) of this section.
(B) Ventilation. Must perform observation of chest excursions
and/or auscultation of breath sounds.
(C) Circulation. Must take and record an initial blood pressure
and pulse and thereafter as appropriate except as provided in paragraph (4)
of this section.
(3) An appropriate time oriented anesthetic record must be
maintained including documentation of individual administering the drug(s)
and showing the name(s) of drug(s) and dosage(s) used.
(4) In selected circumstances, enteral conscious sedation may
be utilized without pulse oximetry or taking blood pressure and pulse. These
circumstances include: sedation administered for brief procedures; extremely
young children, patients who cooperate poorly due to unwillingness or inability
to follow instructions, or patients whose level of anxiety will tend to be
heightened by monitoring. When these situations occur, the dentist responsible
for administering enteral conscious sedation must document the reasons preventing
the recommended monitoring.
(i) Recovery and Discharge:
(1) recovery from enteral conscious sedation must include:
(A) positive pressure oxygen and suction equipment must be
immediately available in the recovery area and/or operatory;
(B) continual monitoring of vital signs when the sedation/anesthesia
is no longer being administered; i.e., the patient must have direct continuous
supervision until oxygenation, and circulation are stable and the patient
is appropriately responsive for discharge from the facility;
(C) the dentist must determine and provide for documentation
that oxygenation, circulation, activity, skin color and level of consciousness
are appropriate and stable prior to discharge;
(D) must provide explanation and documentation of written postoperative
instructions to patient and/or a responsible adult at time of discharge;
(E) the dentist must determine that the patient has met the
following discharge criteria prior to leaving the office:
(i) cardiovascular function satisfactory and stable;
(ii) airway patency uncompromised and satisfactory;
(iii) patient easily arousable and protective reflexes intact;
(iv) state of hydration adequate;
(v) patient can talk, if applicable;
(vi) patient can sit unaided, if applicable;
(vii) patient can ambulate, if applicable, with minimal assistance;
(viii) For the child who is very young or disabled, and incapable
of the usually expected responses, the pre-sedation level of responsiveness
or the level as close as possible for that child should be achieved.
(ix) Responsible individual is available.
(2) patients who have unusual reactions to enteral conscious
sedation must be assisted and monitored either in an operatory chair or recovery
room until stable for discharge;
(3) the dentist must determine that the patient is appropriately
responsive prior to discharge.
(j) Emergency Management. The dentist, personnel and facility
must be prepared to treat emergencies that may arise from the administration
of enteral conscious sedation, and must have the ability to provide positive
pressure ventilation with 100% oxygen with an age appropriate device.
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