21 NCAC 16Q .0405         MODERATE PEDIATRIC CONSCIOUS SEDATION CLINICAL REQUIREMENTS AND EQUIPMENT

(a)  A dentist holding or applying for a permit to administer moderate pediatric conscious sedation shall be subject to the requirements set out in Section .0100 of this Subchapter.

(b)  In addition to the drugs listed in Rule .0103(c)(3) of this Subchapter, an unexpired muscle relaxant shall be immediately available and be accessible from the operatory and recovery rooms.

(c)  In addition to the requirements set out in Rule .0103(c)(4) of this Subchapter, the permit holder's emergency manual shall include assignments to be performed in the event of emergency by a BLS-certified auxiliary dedicated to patient monitoring.

(d)  In addition to the requirements set out in Rule .0103(e) of this Subchapter concerning pre-operative procedures, the permit holder shall ensure that patients who have been administered moderate pediatric conscious sedation are monitored for alertness, responsiveness, breathing, and skin coloration during waiting periods before operative procedures by the permit holder or an auxiliary dedicated to patient monitoring.

(e)  As part of the pre-operative assessment required by Rule .0103(e) of this Subchapter, the permit holder shall evaluate the patient for health risks as follows:

(1)           a patient who is medically stable and who is ASA I or II shall be evaluated by reviewing the patient's current medical history and medication use; or

(2)           a patient who is not medically stable or who is ASA III or higher shall be evaluated by the permit holder's consultation with the patient's primary care physician or consulting medical specialist regarding the potential risks posed by the planned dental procedure.

(f)  If a patient immobilization device is used, the permit holder shall ensure that:

(1)           the device is applied to avoid airway obstruction or chest restriction;

(2)           the patient's head position and respiratory excursions are checked frequently to ensure airway patency;

(3)           a hand or foot is kept exposed; and

(4)           the patient is under observation by the permit holder or a BLS-certified auxiliary at all times.

(g)  During the sedation procedure, a moderate pediatric conscious sedation permit holder shall not administer anesthetic or sedative agents:

(1)           designed by the manufacturer for use in administering general anesthesia or deep sedation;

(2)           determined by the manufacturer to be contraindicated for use in moderate pediatric conscious sedation; or

(3)           in amounts exceeding the manufacturers' maximum recommended dosages, unless the permit holder documents in the sedation record the clinical reason for exceeding the maximum recommended dosage for the patient.

(h)  In addition to the requirements set out in Rule .0103(h) of this Subchapter concerning the patient treatment record, the permit holder shall maintain documentation of pre-sedation instructions and information provided to the patient or person responsible for the patient, which shall include:

(1)           objectives of the sedation;

(2)           anticipated changes in patient behavior during and after sedation;

(3)           instructions to the person responsible for a patient transported in a child safety seat regarding patient head position to avoid airway obstruction;

(4)           a 24-hour telephone number for the permit holder or his or her BLS-certified auxiliaries; and

(5)           instructions on limitations of activities and dietary precautions.

(i)  For purposes of Rule .0104(b)(2) of this Subchapter, during an evaluation, a moderate pediatric conscious sedation permit holder or applicant shall demonstrate competency in the deployment of an intravenous delivery system as follows:

(1)           a permit holder or applicant who uses intravenous sedation shall demonstrate the administration of moderate pediatric conscious sedation on a live patient, including the deployment of an intravenous delivery system; and

(2)           a permit holder or applicant who does not use intravenous sedation shall describe the proper deployment of an intravenous delivery system and shall demonstrate the administration of moderate pediatric conscious sedation on a live patient.

History Note:        Authority G.S. 90-28; 90-30.1; 90-48;

Eff. June 1, 2017;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. January 9, 2018;

Amended Eff. June 17, 2024; February 1, 2019; August 1, 2018.