Practice Guidelines for Intravenous Conscious Sedation in Dentistry (Second Edition, 2017).

Abstract

Intravenous sedation is a method of intravenously administering a sedative so that a patient can receive dental treatment safely and comfortably; it is a patient management method that reduces or eliminates fear and anxiety during treatment.1,2 This method is a specialized treatment that is used worldwide and responds to the need to prevent medical complications, underlying disease exacerbation, and stress during oral/dental surgical treatment under local anesthesia in patients with dental phobia or medical compromise.3,4Dental treatment is characterized by the fact that the surgical field and the airway are the same site; the use of a mouth prop narrows the airway, and water stored in the oral cavity easily flows into the pharynx/larynx due to the use of dental rotary and cutting equipment. Maintaining consciousness, swallowing and upper respiratory tract reflexes, and sufficient respiration during dental treatment is extremely important in preventing airway obstruction and aspiration.1,5 Conscious sedation is a procedure in which the level of sedation is regulated so that consciousness is maintained. Anxiety and fear of dental treatment and oral surgical procedures are frequently eliminated; calm is maintained, and the patient can respond to verbal command or light physical stimuli.5,6 The term conscious sedation that is used in Japan is equivalent to the term minimal to moderate sedation in the American Dental Association (ADA) guidelines7 and minimal to moderate sedation/analgesia in the American Society of Anesthesiologists (ASA) guidelines.8However, in clinical dentistry, there are cases in which behavioral management is performed with sedation to deliberately cause a loss of consciousness for a period of time.9 This state is called “deep sedation.” Deep sedation is associated with more side effects and complications, such as airway obstruction and aspiration, compared with conscious sedation. Moreover, because advanced knowledge and techniques are required, it is necessary to perform perioperative management similar to that for general anesthesia.6,10The ASA statement regarding monitored anesthesia care notes that providers of moderate sedation must be qualified to recognize deep sedation, manage its consequences, and adjust the level of sedation to a moderate or lesser level.11 In Japan, several clinicians fail to understand the difference between “conscious sedation” and “deep sedation” in terms of the common practices, concepts, and indications. The reason is that there are no comprehensive guidelines on proper management under “conscious sedation,” which is a basic technique of intravenous sedation. Therefore, in these guidelines, similar to the first edition, standard guidelines have been presented, so that management of intravenous conscious sedation can be performed safely and effectively in adults.The first edition of these guidelines was issued in September 2009. It was decided that a revised version of that report should be issued, since the first publication was issued 7½ years ago. Since evidence regarding relatively new sedative drugs in dental practice is lacking, these new drugs are not covered in this revised edition. However, evidence indicating the utility of propofol, a conventionally used sedative, has been reported and was added to this revised edition. In our principle of conscious sedation, no analgesic drugs were included, and benzodiazepine and propofol were included when used alone or in combination. Intravenous sedation with propofol should be performed only by appropriately trained practitioners.We should explain the legal status of the provision of sedation/general anesthesia in Japan. General anesthesia can be legally provided by any dentist in Japan. Dental students receive more than 50 hours of lectures on anesthetic management in dental school, with the total varying between universities. The faculties in Departments of Dental Anesthesiology are responsible for training in dental anesthesia. Thus, the national examination for licensing of dentists includes the field of anesthetic management. Undergraduate education qualifies a dentist in Japan to provide anesthetic care, including general anesthesia, for dental treatment. It is, however, obvious that further coursework is required to ensure the safe provision of anesthetic care in dentistry. The Japanese Dental Society of Anesthesiology is responsible for overseeing such training courses. In 1977, the Japanese Board of Dental Anesthesiologists was established as a qualifying examination for anesthesia providers. Most anesthesia providers in dentistry have taken specific residencies in a Department of Dental Anesthesiology and have passed a board examination after approximately 3 years of full-time training. As dental anesthesiologists, we generally advise trainee dentists, including oral surgeons and general practitioners, who are willing to learn dental anesthesia that they should provide intravenous sedation by themselves in a private office only after they obtain certification by the Japanese Board of Dental Anesthesiologists (ie, completed residency training in dental anesthesiology). However, some oral surgeons and general practitioners train in providing intravenous sedation under previously trained oral surgeons or medical anesthesiologists who are skilled at sedation management. Even though serious adverse events related to dental anesthesia are quite rare in Japan, our society continues to provide education and continuing education in safe anesthetic practices for health care providers in this field. Thus, this guideline is one of the methods our society uses to promote safe dental anesthesia management.To introduce this revised version to dental practitioners around the world who perform sedation, we hereby publish an English version. It should be noted that some newer guidelines of other organizations were not available at the time of the Japanese publication. Therefore, reference is made to the most recent guidelines of other organizations as of 2017, when this guideline was published in Japanese.These guidelines were prepared in accordance with the procedure manual of “evidence-based medical care”12 by the Working Group of the Japanese Dental Society of Anesthesiology consisting of board-certified dental anesthesiology specialists and reviewed by six societies in related fields (Japanese Society of Oral and Maxillofacial Surgeons, Japanese Society for Disability and Oral Health, Japanese Society of Oral Implantology, Japanese Society of Pediatric Dentistry, Japanese Society of Gerodontology, Japanese Society of Dentistry for Medically Compromised Patients).Details concerning the targets of the literature search, evidence levels, and recommendation levels are described, as follows.Evidence Levels I and II are classified as degree of recommendation A, evidence level III as degree of recommendation B, and evidence Levels IV to VI as degree of recommendation C. When reports that met level I and II criteria could not be found, if the items were determined to be highly or moderately recommended by the working group members, they were marked as “degree of recommendation A or B evaluated by the Working Group on Guidelines Development.” When a quoted statement was not derived from evidence-based medicine, although it was from a systematic review, it was classified as “Level VI in I” and Grade B. In practice, there were some CQs for which it was difficult to find evidence, and they were consolidated as the opinion of the working group.The purpose of these guidelines is to support medical treatment, but they do not restrict the discretion of the dentist/physician or limit medical treatment. How these guidelines are used in the clinical setting should be determined by the patient's needs and the expert knowledge and experience of the dentist/physician.It is our hope that patients who cannot receive standard dental treatment will be able to receive appropriate dental treatment by undergoing safe and effective intravenous conscious sedation and that these guidelines contribute to the progress of dental care and patient health.No financial assistance from a company or other entity was provided to create these guidelines. The members of the guidelines working group have no conflicts of interests to declare at the time of publication.The various clinical issues are addressed in a question and answer format.Although it is desirable to follow the guidelines for general anesthesia, it is important to focus on the detailed medical interview (medical interview) and recording of vital signs (degree of recommendation: A evaluated by the Working Group on Guidelines Development). If the patient has or is suspected to have a systemic illness, it is advisable to consult with the attending physician (medical inquiry) via medical records (degree of recommendation: B evaluated by the Working Group on Guidelines Development). Comprehensive evaluation should be carried out by the attending dentist or dentist in charge who is knowledgeable and skilled (degree of recommendation: A evaluated by the Working Group on Guidelines Development).Refer to: CQ 2–6). What education and training are necessary for intravenous sedation?In general, patients with ASA physical status classification I or II are considered appropriate for intravenous sedation in dentistry. It is necessary to verify whether or not medical treatment is being performed based on the latest guidelines for each disease (refer to Medical Information Network Distribution Service). Moreover, it is also necessary to confirm whether or not adequate medical management is being performed.13,14Perform a detailed verbal examination (medical interview), which covers disease history, current disease state, medications taken, family history, discomfort level during past dental treatments, and any allergies to food, medicine, etc (level IV).5,15,16 After the medical interview and measurement of vital signs, preoperative screening tests and comprehensive assessment of the patient's general status should be performed, and, if necessary, written inquiries to the treating physician (medical information request form) should be made. This is relatively acceptable if there is only one complicating factor and medical management is sufficient; however, there are cases in which the patient visits multiple medical institutions for multiple systemic or chronic diseases or is administered medication for long periods, and it is appropriate to evaluate the general status of the patient based on all of his or her information. Furthermore, the goal of patient evaluation should be determined by how well the patient can tolerate the planned dental treatment, which sedation method is optimal for the patient, and so on (level IV).17,18Particularly in cases of intravenous sedation in outpatients, it is necessary to perform more detailed preoperative interviews before surgery (interviews of family members or accompanying persons may be necessary in some cases) and measure vital signs. It is important to accurately perform preoperative evaluations, since management after patients return home is not possible.Indications/contraindications of intravenous sedation are considered to include the following (degree of recommendation: B).(Note) The purpose of intravenous sedation is to relieve stress. It is necessary to differentiate this from deep sedation for the purpose of behavior modification in persons with disabilities and uncooperative children. In the case of patients with cerebral palsy, muscle tension and involuntary movements are frequently worsened by stress and can be relieved by intravenous sedation. In patients with Parkinson's disease, tremor at rest can be reduced by intravenous sedation.The application of intravenous sedation is wide ranging, and it can be used in most patients (level VI).5 However, care is especially needed when performing intravenous sedation in patients who require special care (level VI, level IV in level I).8,19The incidence of complications during intravenous sedation, especially respiratory complications, such as respiratory depression and airway obstruction, is high; in some cases, intraoperative airway management by mask ventilation and endotracheal intubation may be necessary. Therefore, caution is needed with intravenous sedation in patients in whom airway management is difficult (eg, severe obesity, short neck, neck tumor, cervical spine injury, mandibular micrognathia, trismus, tonsillar hypertrophy, cerebral palsy).For intravenous sedation, routine preoperative screening tests not based on specific indications are not necessary (degree of recommendation: A). However, after recording the patient's medical history and performing a physical examination, if necessary, a preoperative evaluation should be performed similar to one performed before surgery with general anesthesia (degree of recommendation: A evaluated by the Working Group on Guidelines Development).There were no significant differences in the rate of complications between the group who received and the group who did not receive a routine preoperative screening test (level II).20,21 In the absence of specific indications, routine preoperative laboratory tests contribute little to patient care (level IV).22 Medical history evaluation and careful physical examination are important for the preoperative evaluation of patients, and based on this information, it must be determined whether further preoperative evaluation is necessary (level VI).23The attending anesthesiologist should provide a description of the procedure to the patient and obtain consent (informed consent) after distributing the descriptive pamphlet in advance (degree of recommendation: B). A description by an anesthesiologist with extensive experience and knowledge is more effective in relieving anxiety of intravenous sedation compared with one by an inexperienced anesthesiologist (degree of recommendation: B).After the information describing the anesthetic procedure was given to patients in advance, they could deepen their understanding of the procedure with the anesthesiologist's description (level III).24 Compared with a description by an anesthesiologist with less experience and less knowledge, a description by an anesthesiologist with extensive experience and deep knowledge significantly reduced patients' anxiety (level III).25It is recommended that preoperative oral intake restriction be implemented for intravenous sedation (degree of recommendation: A evaluated by the Working Group on Guidelines Development). Even for subjects who undergo conscious sedation, oral intake restriction is necessary because if the patient unintentionally enters a deep state of sedation, the possibility of aspiration cannot be ruled out.The following are recommended as oral intake restrictions (degree of recommendation: B).In the “Practice Guidelines for Sedation and Analgesia by Non-anesthesiologists” of the ASA, it is recommended that preoperative oral intake restriction be implemented (level IV in level I).8 However, evidence on oral intake restriction for intravenous sedation during dental treatment is poor, and no conclusion has been reached. One report suggests that if the level of sedation is similar to that of conscious sedation, there is no need for preoperative oral intake restriction (level V).26,27 However, there is also an opinion that even under conscious sedation, intake restriction should be applied similar to deep sedation and general anesthesia (level IV).28When performing intravenous sedation, some form of oral intake restriction was implemented in 21 out of 23 university hospital dental anesthesiology departments in Japan (level VI).29 The results of a questionnaire on intravenous sedation from 70 institutions showed that some type of absolute fasting was implemented in 50 to 60% of facilities. However, 10% of facilities did not implement any type of fasting (level VI).5The ASA guidelines list recommended preoperative oral intake restriction methods (level I).8 According to a study by Kurozumi et al,29 the mean fasting time was 8.3 ± 2.3 hours, and the mean liquid fasting time was 6.8 ± 3.1 hours (level VI). In a report by Campbell and Smith,30 200 patients older than 65 years who underwent an oral surgical procedure were allowed to ingest solid food up to 8 hours before and drink clear liquids up to 3 hours before intravenous sedation was performed. No intraoperative or postoperative nausea, vomiting, aspiration, or dehydration was noted. Morse et al31 administered a survey to Japanese dentistry departments and dental university hospitals; they found that the mean fasting time was 5.5 ± 3.0 hours (0–12 hours), and the mean liquid fasting time was 3.7 ± 2.4 hours (0–9 hours; level VI).There are no reliable data on the incidence of vomiting and aspiration during dental procedures under intravenous sedation. However, severe aspiration has been reported in endoscopic surgery under intravenous sedation. As various dental procedures can induce vomiting, it is important to adhere to preoperative oral intake restriction.To safely perform intravenous sedation, it is necessary to receive training in anesthetic pharmacology, anesthesia technique, systemic physical management, and emergency resuscitation (degree of recommendation: A evaluated by the Working Group on Guidelines Development).According to the “Practice Guidelines for Sedation and Analgesia by Non-anesthesiologists” of the ASA (level VI in I),8 when sedation is performed by a nonanesthesiologist, it is strongly recommended that the practitioner receive training in anesthetic pharmacology, anesthesia technique, systemic management, and emergency resuscitation. In addition, in the “Policy Statement: Use of Sedation and General Anesthesia by Dentists” (level VI),32 “Guidelines for the Use of Sedation and General Anesthesia by Dentists” (level VI),7 and “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (level VI),33 the ADA provides guidance on education and training and recommends practitioners undergo this training before performing sedation.In predoctoral (dental student) dental education in Japan, the following classes are offered for dental anesthesiology: “anesthesia and the nervous system,” “anesthesia and the respiratory system,” “anesthesia and the circulatory system,” “anesthesia and the endocrine system,” “anesthesia and the urinary system,” “anesthesia and circulatory disorders,” “anesthesia and immunity,” “action of anesthetics,” “application and pharmacokinetics of drugs,” “side effects and adverse effects of drugs,” “preoperative examination and systemic diseases,” “vital signs and systemic complications,” “sedation technique,” and “cardiopulmonary resuscitation; basic life support and advanced life support.”34Sedatives are administered continuously or intermittently during intravenous sedation. In addition, in some cases, administration of an inotrope or emergency drugs may be required during patient management. Therefore, during sedation, it is necessary to pay attention to complications that arise from venous access itself and acquire the necessary skills to prevent them (degree of recommendation: A evaluated by the Working Group on Guidelines Development).According to the results of a questionnaire survey on intravenous sedation administered to 77 institutions, including dental universities and dental schools throughout Japan, the actual treatment time during intravenous sedation was as follows: within 1 hour, 37.8%; within 1 to 2 hours, 34.9%; within 2 to 3 hours, 16.9%; within 3 to 4 hours, 7.6% (level IV).5Cases of seizures, hyperventilation syndrome, and cardiac arrest following severe vasovagal reflex caused from the establishment of intravascular access in intravenous sedation have been reported (level V).35,36 There have also been reports of vasovagal reflex with suppression of the circulation requiring use of circulatory agonists and/or emergency treatment (level V).37,38During intravenous sedation, it is necessary to secure venous access over a relatively long period of time; it is desirable to select an indwelling catheter to avoid vascular injury or fluid leak when body movements occur and to select a large blood vessel to prevent vascular pain or postoperative phlebitis. Furthermore, it is necessary to have humane and appropriate puncture technique.If the level of sedation is within the range of conscious sedation, the practitioner performing the dental treatment can also perform intravenous sedation. However, the practitioner needs to acquire considerable knowledge and skills concerning sedation and emergency treatment. It is also necessary to have 1 or more assistants devoted to monitoring patient status (degree of recommendation: C).Although there are little data on the subject, in principle, intraoperative sedation management should be performed by a person who is not performing the dental treatment (level VI).5 However, there are no studies that form the basis for the recommendations in the “Guidelines for Sedation and Analgesia by Non-anesthesiologists” of the ASA8 and the sedation guidelines of the American Academy of Pediatrics/American Academy of Pediatric Dentistry.39 Therefore, the expert committee determined who should perform intravenous sedation according to the target level of sedation. That is, if the target sedation level is moderate (conscious sedation), the practitioner performing the dental procedure may also perform intravenous sedation, but the practitioner must be a person with expert knowledge and skill who can sufficiently handle emergencies. In addition, one assistant assigned to monitor the condition of the patient is necessary. However, it has been noted that when implementing deep sedation, the specialist devoted to patient management must be assigned separately from the surgeon (level VI).Rodgers investigated 2889 patients who underwent intravenous sedation that was performed by an oral surgeon during the 7-year period from December 1994 to November 2001; the reported incidence of complications was 2.67% (77/2889; level V).40 In this study, the oral surgeon who performed intravenous sedation was knowledgeable about anesthesia practices (National Dental Board of Anesthesiology certified) and received advanced cardiovascular life support training every 2 years. Intraoperative patient monitoring was performed by a dental assistant who had taken a course on anesthesia practices. In addition, Rodgers and colleagues conducted a similar study from December 2001 to November 2008 and reported that the incidence of complications was 1.80% (60/3320; level V).41 The sedation level ranged from moderate to deep sedation in most patients, but no patients received intravenous general anesthesia.Lee et al reported that there was no difference in the incidence of intraoperative complications (0.4 and 0.25%, respectively) when intravenous sedation was performed by the oral surgeon performing dental treatment or when performed by an anesthesiologist or a nurse anesthetist (level V).42During sedation, continuous monitoring of the patient's breathing status, circulatory dynamics, and so forth must be performed. It is also necessary to respond appropriately to the degree of sedation, which constantly changes because of the conditions of the surgery. Furthermore, when there is a sudden change in the condition of the patient, prompt response is required. When the person performing the dental treatment also performs intravenous sedation, it is difficult to fully understand the status of the patient under sedation; conversely, when the practitioner concentrates on patient management, the progress of the dental treatment is hindered. Based on the above findings, it is the authors' opinion that it is desirable for intravenous sedation to be implemented by a different person from the one performing the dental treatment. In recent years, it has been reported that intravenous sedation, including deep sedation performed by the oral surgeon who is performing the dental treatment, has been performed safely; however, in such cases, it was also essential to have a well-trained nurse familiar with intravenous sedation and methods of evaluating the general status of the patient to concentrate on patient monitoring during the procedure.It is preferable that the duration of treatment under intravenous sedation is less than 2 hours (degree of recommendation: B evaluated by the Working Group on Guidelines Development).In the questionnaire survey, the percentage of cases according to actual treatment duration during intravenous sedation was as follows: within 1 hour, 37.8%; from 1 to 2 hours, 4.9%; from 2 to 3 hours, 16.9%; from 3 to 4 hours, 7.6%.5 However, the percentage of procedures that were considered to have appropriate treatment durations were as follows: within 30 minutes, 1%; within 1 hour, 25.7%; within 1.5 hours, 14.3%; within 2 hours, 44.3%; within 3 hours, 14.3% (level VI).5 In a study of intravenous sedation in 200 elderly patients (mean age: 72 ± 4.2 years) who received oral surgical treatment, the treatment duration ranged from 6 to 129 minutes (level VI).30 Lepere and Slack-Smith43 performed dental procedures under intravenous sedation in 85 patients in private dental clinics. Treatment duration was 8 to 185 minutes (mean time: 71.4 ± 37.5 minutes; median time: 64 minutes). Messieha et al44 performed independent intravenous sedation (using fentanyl, midazolam, propofol, etc) in 100 patients and retrospectively investigated the treatment duration and complications. The mean treatment duration was 97.5 ± 42.39 minutes, and complications occurred in 6 cases.There are no highly reliable studies that have examined the length of treatment time, quality of sedation, and incidence of complications during intravenous sedation. However, when the treatment time under intravenous sedation is prolonged, the patient often becomes agitated, making it difficult to maintain sedation. In an investigation of the treatment duration under intravenous sedation, most cases were completed within 2 hours, and there were few reports of serious complications. Therefore, it is considered reasonable to set the guideline for treatment duration under intravenous sedation to 2 hours.During intravenous sedation, caution is needed regarding the occurrence of the following complications (degree of recommendation: A).During intravenous sedation, respiratory complications, such as respiratory depression and glossoptosis, frequently occur (level VI).5 According to one study that analyzed the causes of intravenous sedation failure, the most common reason why the scheduled treatment could not be performed was patient disturbance/excitement (agitation; level V).45 Refer to the section on medication and the side effects caused by each drug that is used in intravenous sedation.In implementing intravenous sedation, it is important to recognize the possibility of these complications, and practitioners must adequately monitor patients and prepare countermeasures against these complications.The puncture sites for intravenous access include the dorsum of the hand, radial side of the wrist joint, antecubital fossa, and so on. When selecting the cephalic vein, it is recommended to avoid puncturing at a site close to the wrist joint (degree of recommendation: C). If puncturing at the antecubital fossa, it is desirable to select a cutaneous vein on the radial side of the antecubital fossa (degree of recommendation: C). If the patient feels an abnormal sensation or numbness in the punctured area, remove the needle promptly. Care is also necessary when removing the needle (degree of recommendation: C). Although the incidence of nerve injury and tissue damage accompanying venipuncture is small, it should be performed after fully understanding the anatomy of the surrounding region of the puncture site (degree of recommendation: A evaluated by the Working Group on Guidelines Development).The nerves that may be damaged from intravenous puncture include the antebrachial cutaneous nerve in the antecubital fossa, the superficial branch of the radial nerve at the wrist, and the dorsal sensory branches in the hand (level V).46–48 When puncturing the cephalic vein of the wrist, it has been reported that puncturing should be performed on the central side at 12 cm or further from the styloid process to avoid nerve damage to the superficial branch of the radial nerve (level V).49 It has been reported that, when performing venous puncture at the cubital fossa, the median basilic vein should be avoided.48The incidence of nerve damage accompanying venipuncture is rare. When minor cases were included, the incidence was 1 out of 6300, and when limited to patients with a recovery period of 1 month or longer, the incidence was 1 out of 20,500 cases50; 3 out of 560,000 patients took more than a year until fully healed51 (level V).Although it is impossible to completely prevent peripheral nerve damage during vascular puncture, the necessity of avoiding puncture at sites with a high risk of nerve damage and prompt response when neurological symptoms occur has been previously stressed (level V).47,48 In addition, cases have been reported in which nerve damage occurred not only during venous puncture but also during removal of the catheter (level V).52Although the incidence of peripheral vascular injury due to venipuncture is rare, when performing vascular access via the cephalic vein, sufficient anatomical knowledge is necessary to avoid complications, such as the possibility of radial nerve damage. Furthermore, when radiating pain or numbness occurs during needle insertion, stop immediately and remove the needle.Consciousness, ventilation, oxygenation, and circulation (pulse rate and blood pressure) should be monitored con