Oral Sciences n3 Braz J Oral Sci. 9(1):7-10 Original Article Braz J Oral Sci. January/March 2010 - Volume 9, Number 1 Intravenous procedural sedation: an alternative in the treatment of patients with intellectual disability Cíntia Megid Barbieri1, Alessandra Cristina Gomes2, Taís Elisabete Crivellaro de Menezes2, Sandra Maria Herondina Coelho Ávila de Aguiar3 Received for publication: June 24, 2009 Accepted: March 03, 2010 Correspondence to: Sandra M. H. C. Ávila de Aguiar Faculdade de Odontologia de Araçatuba - UNESP Rua José Bonifácio, 1193 CEP: 16.015-050 Araçatuba - SP - Brasil E-mail: saguiar@foa.unesp.br Abstract Conscious sedation has become established as an important alternative to general anesthesia (GA) in dental treatment of patients with intellectual disability (ID). Aim: to investigate dental patients undergoing sedation using a mean dose of 0.6 mg/kg intravenous midazolam and the adverse events of sedation in patients with ID. Methods: This study analyzed the records of 163 dental patients with ID aged between 2 and 76 years who had undergone conscious intravenous sedation (CIV) using a mean dose of 0.61 mg/kg of midazolam at Araçatuba Dental School, São Paulo State University, Brazil. The efficacy and complications induced by CIV were evaluated in each subject. Results: CIV was effective for dental treatment in 80% of the cases. A total of 626 dental procedures were performed. The mean treatment time was 33.9 minutes. There was statistically significant difference (p<0.05) between absence and presence of adverse reactions. Adverse reactions were observed in 21.47% of the cases. Conclusions: The results of this study showed that CIV is a useful method for dental treatment of patients with ID and these patients can need higher doses of sedative to reach an adequate level of sedation. Keywords: dental anesthesia, dental care, intellectual disability, sedation. Introduction It has been acknowledged that the population with disabilities has higher rates of poor oral hygiene, gingivitis, and periodontitis than the general population. Moderate or severe gingivitis has been found almost ordinarily, with degree and extent increasing with age and severity of mental retardation1-2. Moreover, special needs patients tend to have more decayed and missing teeth compared to non- disabled patients3. An extended series of reports on the use of dental services by children and adults with disabilities focuses on limited physical access to buildings, limited practitioner willingness to provide care, and associated insurance and financial difficulties resulting in longer periods between dental visits and a tendency to have had extractions at the last visit4-5. Sedation is a useful method for relieving dental fear and anxiety in patients, and it is often essential for people with ID undergoing dental treatment 6. Benzodiazepines are currently the pharmacological group of choice due to their greater effectiveness provided by their efficacy and safety margin. In addition, muscular relaxant effect of these drugs helps calming the patient down. In this group, midazolam has been efficient in controlling the anxiety and maintaining blood pressure and oxygen saturation within normal levels7-12. The pharmacological characteristics that made midazolam a drug of choice for clinical sedation are: quick action, short half life and suitable sedation duration. 1Dentist, Special Care Clinic of the Araçatuba Dental School, Unesp – Univ Estadual Paulista, Brazil 2Postgraduate Student, Department of Pediatric Dentistry, Araçatuba Dental School, Unesp – Univ Estadual Paulista, Brazil 3Professor, Department of Pediatric Dentistry, Araçatuba Dental School, Unesp – Univ Estadual Paulista, Brazil 8 Braz J Oral Sci. 9(1):7-10 Its anxiolytic, hypnotic and amnesiac effects compose the main objectives to be reached with its utilization. Moreover, the diversity of administration routes (oral, rectal, intramuscular, endovenous and intranasal) offers alternatives that better suits a great number of patients7-8,12-13. Conscious intravenous sedation (CIV) is frequently provided for dental patients as an alternative to GA in the Center of Dental Care to Special Needs Patients of Araçatuba Dental School, São Paulo State University (CAOE/FOA/ UNESP), Brazil. However, the decision about the required dose for an adequate level of sedation is difficult because the effect of sedation cannot be adequately assessed in patients with severe ID. It has been reported that a high dose of sedative is required for patients with ID to obtain an adequate level of sedation9,14, but an appropriate sedative dose has not been satisfactorily established for dental patients with ID. Thus, the authors investigated dental patients undergoing sedation using a medium dose of 0.6 mg/kg intravenous midazolam and the adverse events of sedation in patients with intellectual disability (ID). Material and methods One hundred and sixty three mentally handicapped patients were treated under CIV at the CAOE/FOA/UNESP, Brazil between January and July 2003 (Figure 1). This treatment was chosen because each patient had previously exhibited combative behavior sufficiently negative to dental treatment using routine behavior management techniques or presented muscular spasticity (cerebral palsy patients). The Research Ethics Committee of Araçatuba Dental School, São Paulo State University, Brazil, approved the study (Protocol #FOA 876/2003). The age of the patients undergoing CIV ranged from 2 to 76 years. Only patients with ASA I or ASA II physical status were eligible for the study. CIV was induced with a bolus intravenous administration of midazolam ranging 0.3 to 1.2 mg/kg for a mean dose of 0.61 mg/kg and all patients were immobilized with bands to control involuntary movements that might occur during the dental procedure. The dental treatment started 2 min after midazolam administration. Once the patients were sufficiently sedated, local anesthesia with 2% lidocaine with 1/100,000 adrenaline was delivered before the clinical procedures. The maximum Fig. 1. Classification of patients according to the handicapping condition. Figure 2. Number of dental procedures performed under sedation. dose of local anesthetic was limited strictly to 4.4 mg/kg for all patients. Resuscitation equipment was available if required and a medical team followed each treatment session. The efficacy of sedation and the duration of the dental treatment were investigated. The efficacy of sedation was evaluated by judgment of the patient cooperation to the dental treatment and the determination of the dose to be administered to each patient was accomplished by the cardiologist responsible for the sedation at CAOE/FOA/ UNESP, according to the patient’s body weight, physiological, nutritional and pathological evaluation. In the present study, the mean effective dosage was 0.61 mg/kg. According to the observations made by the senior researcher, the sedation was considered to be effective when the patient was classified as “Cooperative” (the patient was sedated and remained awake, sleeping or sleepy during the treatment session, but was cooperative). The sedation was considered not-effective when the patient was classified as “Non-cooperative” (the patient was awake and uncooperative, not allowing the procedures to be done, even after sedation. The adverse effects of CIV were also evaluated in each subject. The incidence of pre- and post- CIV complications, including vomiting, respiratory depression and others (tremor, tachycardia), were also evaluated. Data were analyzed statistically by the chi-square test. Statistical differences were considered significant at p<0.05. Results A total of 626 dental procedures, such as amalgam, resin and glass ionomer cement restorations, sealants, extractions, scaling and root planing, root canal therapy, and others (frenectomy, ulectomy and biopsy), were performed (3.8 procedures per patient on the average) (Figure 2). The mean treatment duration was 33.9 min (Table 1). In 56% of the patients, all necessary procedures were completed in a single session. CIV was effective for dental treatment in 80% of the subjects with ID. There was accentuated resistance in 20% of the patients during the dental procedures, and these patients were subjected to GA in another day. There was no statistically significant association (p>0.05) between midazolam dose (mg/Kg) and patient response (Table 2). There was statistically significant difference (p<0.05) between the absence and the presence of adverse reactions Intravenous procedural sedation: an alternative in the treatment of patients with intellectual disability 9 Duration of procedures (Min) Number of subjects 00 – 20 45 (27.6%) 21 – 40 73 (44.8%) 41 – 60 40 (24.5%) 61 – 80 4 (2.4%) 81 – 100 1 (0.7%) Total 163 (100%) Table 1 - Number of subjects according to the duration of procedures in minutes. Side effects Number of subjects Respiratory Depression 27 (55%) Vomiting 11 (22.4%) Fluttering 7 (14.2%) Others 4 (8.4%) Total 49 (100%) Table 3 - Distribution of side effects in the subjects during dental treatment in this study. There were 49 episodes of adverse reactions in 35 patients (only 21.47%), in which 16.5% were related to respiratory depression, 6.7% to vomiting, 4% to flutter and 2.4% to other reactions (Table 3). In these cases, patients received appropriate medical assistance and medication. There was no difference regarding to the dosage per body weight of medication administered to the patients who developed adverse reactions (Table 2). Discussion Over the last few years several management modalities have been developed to overcome difficulties encountered during complex dental procedures for treatment of special needs patients. Various methods of sedation and sedatives have been described for dental treatment for patients with ID as preferred alternative to full GA6,9-10. It is widely accepted that CIV is safer than GA11-13. However, poorly controlled conscious sedation may result in “deep sedation” or even GA with all its attendant risks13. Since the possibility of an exaggerated level of central nervous system depression always exists, the drugs and techniques employed must carry a wide margin of safety, and the physician should be particularly careful to render the loss of reflexes unlikely. This is especially true in some of the disable patients who are chronically medicated, which could alter their response to certain sedative drugs 12. However, it is necessary to emphasize that the highest interaction chances are reported, mainly through the use of oral midazolam, with the following drugs: carbamazepine, phenytoin, rifampicin, roxithromycin, erythromycin, fluconazole and verapamil 7. It is important that during intravenous sedation vital signs including blood pressure, pulse rate, and arterial blood oxygen saturation are continuously and properly monitored and recorded15. Currently, there is divergence among the dose, drugs and administration route used in CIV. The present study describes the use of CIV as an alternative to GA in dental treatment of patients with ID at CAOE/FOA/UNESP, Brazil. A bolus administration of midazolam was performed, which has been reported to be useful in dental treatment16-18. The subjects in this study had previously exhibited behavior sufficiently negative to dental treatment using routine behavior management techniques. However, the intravenous technique resulted in a sedative effect. Carrying out dental care by this method, the patient’s rejection and evasive behavior patterns were reduced as compared with the controls (previous treatment without intravenous sedation). The rate of behavior evaluated as positive were 80% of cases, although the other 20% that exhibited negative behavior were subjected to GA in another day. It was found that intravenous midazolam is a very effective form of sedation for patients with ID. The dose used in intravenous sedation in this study for each patient was obtained by analysis of weight, pathology, behavior and physiology. In this analysis a medium dose was 0.61 mg/kg. The doses used were higher than that used in other studies with patients without ID17-18. In accordance with this result, others studies have also demonstrate that dental patients with ID need higher doses of sedative to obtain an adequate level of sedation9,19. The reason that dental patients with ID required a higher dose of midazolam than other patients is unclear. Variations among individuals are thought to result from pharmacokinetic and pharmacodynamic factors9. In this study, the blood concentration of midazolam was not measured, but it is possible that in subjects with ID it does not increase proportionally to the administrated dose17. In this way, pharmacokinetic pharmacodynamic factors are thought to be involved in the variations of the required dose of sedative for intravenous sedation. The differences in the required doses of midazolam between subjects with ID and other subjects might derive from differences in sensitivity to the sedative because the success will be dependent on the individual response of each patient9. Adverse events are rare in dental anesthesia, and a definitive evaluation of safety requires a long history of treatment using a given technique. While a trial of this size cannot assess the frequency of possible adverse events, the present results indicate a safe technique. The conscious sedation techniques practiced in the present ensured Braz J Oral Sci. 9(1):7-10 Intravenous procedural sedation: an alternative in the treatment of patients with intellectual disability Dose of midazolam mg/kg Positive behavior Negative behavior Presence of side effects Absence of adverse reactions 0.1 – 0.60 kg 63 16 12 68 0.61 – 1.20 67 17 23 60 Total 130 33 35 128 Table 2 - Distribution of behavior and side effects of subjects according to the dose of midazolam (mg/kg) during dental treatment. 10 cooperation and consciousness throughout the procedure and full control of protective reflexes. This procedure presents minimal risk in contrast to GA11. The subjects of this study were able to receive the expected dental care, but complications like vomiting, respiratory depression, flutter, tremor and tachycardia could be noted. Despite these reactions, there were not significant differences for the presence of adverse reaction associated to drug dose (mg/kg). It was defined as a true decrease of oxygen saturation when a pulse oxymeter reading of SpO2 below 92 percent. It was found 27 episodes of true decrease of oxygen saturation in this study. In accordance with others studies, the respiratory depression was the most predominant adverse reaction occurred during conscious sedation15,20-24. The literature shows that children, elderly, obese, and patients with cerebral palsy, autism or medically compromised who were treated with conscious sedation were more susceptible to respiratory problems15,25-26. Supplemental oxygen has been recommended for all patients undergoing CIV27 and in the present study supplementation was used in some cases, which presented respiratory depression. The reported incidence of nausea and vomiting after sedation and local anesthesia is less than that observed after GA (7% versus 14%). Moreover, the time to discharge was shorter for patients receiving sedation28. This study observed a very low complication rate with the use of oral midazolam in dental treatment for patients with ID. In conclusion, the results of this study showed that CIV is a useful method for providing dental care to patients with ID and produced fewer adverse reactions in comparison to GA. The dose used indicated that dental patients with ID need higher doses of sedative to obtain adequate levels of sedation. 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