The authors have declared that no competing interests exist.
Conceived and designed the experiments: VC MH. Performed the experiments: VC MH DF. Analyzed the data: EN VC. Wrote the paper: VC MH EN DF.
The use of midazolam for dental care in patients with intellectual disability is poorly documented. This study aimed to evaluate the effectiveness and safety of conscious sedation procedures using intravenous midazolam in adults and children with intellectual disability (ID) compared to dentally anxious patients (DA). Ninety-eight patients with ID and 44 patients with DA programmed for intravenous midazolam participated in the study over 187 and 133 sessions, respectively. Evaluation criteria were success of dental treatment, cooperation level (modified Venham scale), and occurrence of adverse effects. The mean intravenous dose administered was 8.8±4.9 mg and 9.8±4.1 mg in ID and DA sessions respectively (t-test, NS). 50% N2O/O2 was administered during cannulation in 51% of ID sessions and 61% of DA sessions (NS, Fisher exact test). Oral or rectal midazolam premedication was administered for cannulation in 31% of ID sessions and 3% of DA sessions (p<0,001, Fisher exact test). Dental treatment was successful in 9 out of 10 sessions for both groups. Minor adverse effects occurred in 16.6% and 6.8% of ID and DA sessions respectively (p = 0.01, Fisher exact test). Patients with ID were more often very disturbed during cannulation (25.4% ID vs. 3.9% DA sessions) and were less often relaxed after induction (58.9% ID vs. 90.3% DA) and during dental treatment (39.5% ID vs. 59.7% DA) (p<0.001, Fisher exact test) than patients with DA. When midazolam sedation was repeated, cooperation improved for both groups. Conscious sedation procedures using intravenous midazolam, with or without premedication and/or inhalation sedation (50% N2O/O2), were shown to be safe and effective in patients with intellectual disability when administered by dentists.
A large minority of the population does not possess the cognitive capacity and adaptive skills required to cope with dental treatment and therefore cannot access therapeutic or preventive care. These difficulties particularly concern patients with cognitive impairment but other non-cognitively impaired patients, such as very young children or dentally anxious children and adults, also present behavioural difficulties during dental care leaving them vulnerable to poor oral health or undiagnosed problems
Published studies investigating the effectiveness and tolerance of midazolam used as a single agent for dental treatment are heterogeneous in their evaluation criteria, use different means of administration, concern different populations and are carried out in different settings
For young or anxious children, as for patients with intellectual disability, little specific data are available in these populations
The present study aimed to evaluate the effectiveness and safety of conscious sedation procedures using intravenous midazolam for dental care undertaken by trained hospital dentists in adults and children with intellectual disability (ID) compared with adults and children with dental anxiety (DA).
Three dental practitioners with postgraduate training in midazolam conscious sedation conducted this study at a University Hospital. All have ten to twenty years of experience of the routine use of conscious sedation using both 50% nitrous oxide/oxygen and midazolam IV, IR and PO, in populations with intellectual disability and/or anxiety. All are postgraduate teachers in conscious sedation at the Dental University and University Hospital of Clermont-Ferrand (France).
Approval was obtained from the local ethical comity (CCPPRB Auvergne i.e. “Comité Consultatif de Protection des Personnes se prêtant à la Recherche Biomédicale”) under registration number AU-571, and from the French National Drugs Agency (AFFSAPS), for an initial clinical trial entitled “Conscious sedation with midazolam in patients with dental anxiety: Impact of administration route (oral versus intravenous)”. The registration number on the “Clinical Trials” website for this study was NCT 01874717. However, oral administration was refused by patients or carers most of the time after IV administration or in some cases, an additional intravenous dose was necessary after oral administration. Consequently, in order to respect patients’ choice, the objectives of the study were changed and aimed at comparing patients with different cognitive profiles requiring IV sedation with midazolam for dental care. The Regional Clinical Research Division was immediately informed of this change and there was no additional requirement to resume the study. Furthermore, after update in the French ethical laws related to human research, global approval from the local ethical committee (n°CE-CIC-GREN-11/17) was obtained for all observational studies evaluating the quality of dental treatment performed in the dental university hospital of Clermont-Ferrand (France). This new text clearly stated that dental care under sedation or general anaesthesia was covered by this approval. The agreement specified that all patients visiting the unit should receive oral and written information mentioning that data obtained during dental care could be used anonymously for research purposes unless the patient specifically stated in writing otherwise (tacit agreement).
All children and adults programmed for dental treatment under intravenous sedation with midazolam over a period of 50 months were considered for inclusion in the study. Exclusion criteria were: i) patients in the American Society of Anesthesiologists (ASA) category III, IV or V
Relaxed, smiling, willing, able to converse, best possible working conditions; displays the behaviour desired by the dentist spontaneously, or immediately upon being asked | |
Uneasy, concerned; eye contact but tense facial expression; suspicious of environment; sits spontaneously back in the chair; hands remain down or partially raised to signal discomfort; during a stressful procedure may briefly and rapidly protest to demonstrate discomfort; the patient is willing and able to describe experience as requested; breath is sometimes held; capable of cooperating well with treatment. | |
Tense; tone of voice, questions and answers reflect anxiety; multiple requests for information; hands clench armrests or may be tense or raised without interfering with treatment; sits back spontaneously in chair but head and neck tense; accepts handholding; eye contact; during stressful procedure verbal protest, quiet crying; patient interprets situation with reasonable accuracy and continues to work to cope with his/her anxiety; protests more troublesome; patient still complies with request to cooperate; continuity is undisturbed | |
Reluctant; tends to reject the treatment situation, difficulty in assessing situational threat; frequent sighs; pronounced protest, crying; only sits back in chair after being asked several times, the head and neck remain tense; slight movements of avoidance; tense hands, avoids eye contact; accepts handholding; minor attempts to use hands to stop procedure; wriggling; protest out of proportion to threat or is expressed well before the threat; copes with situation with great reluctance; treatment proceeds with difficulty | |
Very disturbed by anxiety and unable to assess situation; physically very tense, wrinkled eyebrows, eye contact avoided or eyes shut; general crying not related to treatment; prominent avoiding movements, needing physical restraint on occasion; places hands over mouth or on dentist’s arm to prevent treatment, but eventually allows care to progress; pinches lips together but ends up by opening mouth; regularly lifts head from chair; rejects physical contact but may still accept handholding; patient can be reached through oral communication and eventually with reluctance and great effort begins to work to cope; dissociation is only partial; protest regularly disrupts procedure | |
Out of contact, fails to grasp the reality of the threat; inaccessible to oral and visual communication; rejects physical contact; clenches mouth and lips; closes mouth and clenches teeth whenever possible; violent head movements; screaming, shouting, swearing, fighting, aggressive; regardless of age, reverts to primitive flight responses; actively involved in escape behaviour; physical restraint required |
Patients were assigned to two groups. Patients in the dental anxiety group (DA) expressed dental anxiety but had no intellectual disability. Patients in the intellectual disability group (ID) had an appropriate medical diagnosis or attended a special school, home or work placement. The children and adults in the ID group showed anxiety and/or poor cooperation due to difficulty interpreting the dental situation and due to functional and physical barriers to care.
A medical, dental and social evaluation of each patient was undertaken prior to intravenous sedation. This assessment confirmed the absence of a medical contraindication to the use of midazolam and revealed possible problems for intravenous cannulation (anatomical difficulties, difficulty coping with needles…). Patients were informed that an appropriate escort should be present from the start of the sedation session and remain with the patient over the following 24 hours. Oral and written pre- and post- operative instructions were given. When difficulties of anxiety or cooperation linked to the use of a needle were expressed by the patient or his/her carer, topical anaesthesia was prescribed (EMLA® 5% cream: lidocaïne/prilocaïne 50/50) to be applied to the site of cannulation one hour before the appointment. Fasting was not required prior to intravenous sedation, but light meals only were recommended
On attending for treatment under intravenous sedation, adherence to the preoperative instructions was verified and the escort was made fully aware of his or her postoperative role. Medical history and consent were confirmed. If necessary and possible, inhalation sedation (50% N2O/O2) was administered during cannulation in order to reduce anxiety and provide surface analgesia. When it was anticipated that inhalation sedation (50% N2O/O2) would be inadequate or impossible, an oral or rectal premedication was given. Commonly, oral midazolam was administered 10 to 20 minutes before cannulation (midazolam for injection at 5 mg/ml, (
The patient was monitored clinically from the moment of their arrival in the Unit. For most patients, a baseline physiological assessment was established before the administration of any drugs. For certain patients with marked opposition, sedation was commenced and the pulse oxymeter and blood pressure cuff placed as soon as physically possible. Systolic and diastolic blood pressure (SBP and DBP), heart rate (HR) and oxygen saturation (SpO2) were recorded throughout the sedation session and the recovery period (Monitor: DINAMAP ProCare 300). Following cannulation, intravenous midazolam (5 ml ampoules, 1 mg/ml,
From arrival at the hospital, and throughout the session and recovery period, behavioural management techniques were used continuously (e.g. maintenance of physical and verbal contact, positive reinforcement, reassurance, positive suggestion etc.). These techniques were adapted to the age and communication skills of the patient. Time was taken to introduce the patients to the different steps of the procedure and stress reducing strategies were used continually during care. Local anaesthesia was used systematically if there was the least risk of pain during treatment (including subgingival scaling or rubber dam clamp placement…).
1) The first objective was to study the effectiveness of the procedure. The three criteria used to assess effectiveness were the success of the treatment session, the level of cooperation during the session, and any positive change on repeat sedation.
Success: The session was considered a ‘total success’ if the intended dental treatment was completed under intravenous sedation. It was a ‘partial success’ if only part of the planned dental care could be performed. ‘Failure’ was recorded if no dental treatment was possible. The type of treatment undertaken was also recorded.
Level of cooperation: This was assessed using the French modified Venham scale
Repeat sedation: The group of sessions corresponding to a first experience of intravenous sedation with midazolam was compared with the group of repeat sedation sessions. The success rate, the level of cooperation, the rate of adverse effects, and the dose of intravenous midazolam required were compared.
2) The second objective was to study the safety of the procedure. The criteria used to assess safety were: the incidence of adverse events during the sedation and recovery periods, the values of the recorded physiological parameters and the Ramsay score of level of sedation.
Adverse events: These were pre-listed according to 5 categories: respiratory problems (hyper or hypoventilation, desaturation), digestive problems (nausea, vomiting), neurological problems (convulsions, epileptic fit…), behavioural events (euphoria, hyper-excitability…), vaso-vagal effects (sweating, pallor, faint…).
Physiological parameters: The minimal level of oxygen saturation (SpO2), the minimal and maximal values of heart rate (HR), and systolic and diastolic blood pressure (SBP and DBP respectively) were recorded for each session. Normative values for physiological parameters were established (
Ramsay scores: The level of sedation was recorded applying Ramsay scale on first opening the mouth for examination after induction (T4), at the start of actual dental treatment (after local anaesthesia if necessary) (T5) and at the end of dental treatment (T6)
Heart Rate |
Systolic Blood Pressure (mmHg) | Diastolic Blood Pressure (mmHg) | ||||
Age (years) | Standards | Standards | Standards | |||
90 | 65< >160 | 95 | 70< >120 | 55 | ||
70 | 60< >160 | 110 | 70< >130 | 58 | ||
Anxious and agitated or restless, or both | |
Cooperative, oriented, and tranquil | |
Responsive to commands only | |
Exhibiting a brisk response to light glabellar tap or loud auditory stimulus | |
Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus | |
Unresponsive |
The statistical analysis was designed to study any potential differences between patients with DA and patients with ID as regards: age, gender, success rate, Venham scores, adverse events, Ramsay scores and percentage of sessions with physiological parameters out of the normal range. Statistical significance was set at
Characteristics of the patients and progress of conscious sedation sessions: Age difference between the two groups was assessed by t-test. Gender distribution was compared by Fisher-exact test. Comparison of the mean duration of the conscious sedation sessions and of recovery time between the two groups, and comparison of the mean dose of intravenous midazolam, were undertaken using a t-test (α = 0.05). The frequency of the use of inhalation sedation (50% N2O/O2) and/or of premedication for cannulation, were compared between DA and ID groups using Fisher’s exact test.
Success rate and adverse events: The Fisher’s exact test was used to compare the success rate and the percentage of adverse events between the two groups. The type of dental treatment performed was compared using the Pearson chi square test.
Level of cooperation: The distribution of Venham scores at Ti, T0, T1, T2 and T3 was assessed for DA and ID groups. Three levels of cooperation were defined: i) Venham score 0: patient totally relaxed; ii) Venham score 1 to 3: moderate difficulties with cooperation; iii) Venham score 4 or 5: very disturbed patient, restraint necessary for treatment. Analysis of the distribution of the extreme levels (0 on one hand and 4–5 on the other) between patients with DA and with ID was undertaken using the Fisher exact test.
Influence of repeat sessions: The group of sessions corresponding to a first experience of intravenous sedation with midazolam was compared with the group of repeat conscious sedation sessions. The success rate and the rate of adverse effects were compared with a Fisher exact test for DA and ID groups. The distribution of the extreme scores on the modified Venham scale (0 vs 4–5) at each time (Ti, T0, T1, T2, T3) was compared similarly. The dose of intravenous midazolam was also compared applying an independent t-test.
Physiological parameters: Normative values for physiological parameters were established (
The distribution of Ramsay scores at T4, T5, and T6 was compared between groups using a Pearson chi square test.
Ninety-eight patients with ID and 44 patients with DA were included in the study over 187 and 133 sessions of dental care under intravenous midazolam respectively. Demographic characteristics for DA and ID groups are given in
No. Patients | No. Sessions | Male/Female n (%) | Age in years Mean (± SD) [min.-max.] | No. Sessions inpatients <16 years | Type of patients | Sessions(%) | |
44 | 133 | 65/68 (48.9%/51.1%) | 27.0 (±9.5) [7–66] | 5 | Associated medical condition (epilepsy, heart disorder, cancer, drug addiction) | 5% | |
98 | 187 | 113/74 (60.4%/39.6%) | 30.5 (±11.6) [8–57] | 29 | Cerebral palsy | 25.3% | |
Autistic disorder | 41.4% | ||||||
Learning difficulties | 19.1% | ||||||
Down syndrome | 13.6% | ||||||
Rare genetic syndrome | 0.6% |
The average duration of the sedation sessions from administration of premedication to the end of treatment was 72±28 min (min: 20, max: 160) and 103±36 min (min: 25, max: 258) for patients with ID and DA respectively (p<0.05, t-test). Inhalation sedation (50% N2O/O2) was administered during intravenous cannulation in 51.1% (94/184) of sessions for the ID group and 61.4% (81/132) of sessions for the DA group (NS, Fisher exact test). Inhalation sedation (50% N2O/O2) was administered during all or part of dental treatment in 50.0% (39/78) sessions performed in the ID group and 67.1% (47/70) sessions in the DA group. The mean dose of midazolam given intravenously was 8.8 mg ±4.9 mg (min: 3 mg, max: 27 mg) for the ID group and 9.8 mg ±4.1 mg (min: 2 mg, max: 28 mg) for the DA group (NS, t-test). The duration of titration of intravenous midazolam was correlated to the dose administrated (p<0.05, Pearson correlation). Premedication was given before cannulation in 58/187 (31%) sessions for patients with ID (midazolam: n = 55, hydroxyzine: n = 3) and in 4/133 (3%) sessions for patients with DA (oral midazolam: n = 2, hydroxyzine: n = 1, alprazolam: n = 1). Oral midazolam was the most common premedication for patients with ID (49/55). Rectal administration was used for 8 sessions in 8 different patients with ID. Recovery time was not different between the groups: 54±36 min (min: 10, max: 180) for patients with ID and 44±30 min (min: 0, max: 150) for patients with DA.
Planned dental treatment was successfully performed in 90.6% of sessions in patients with DA and 89.1% in patients with ID, with no difference between groups (chi square test, NS). 7.1% of sessions in patients with DA and 10.3% of sessions in patients with ID were a ‘partial success’ (only part of the planned treatment completed). A total failure, or abandon of treatment, was recorded in 3 patients (2 with DA and 1 with ID), and these were subsequently referred for general anaesthesia. Of these patients, one 18 year old woman with DA received 0.5 mg/kg of oral midazolam and 8 mg of IV midazolam. She exhibited Venham scores of 5 throughout the session from the moment of cannulation. One 14 year old girl with DA received 6 mg of IV midazolam. She needed endodontic treatment for a first mandibular molar but she presented Venham scores of 3 or 4 throughout the session. One 13 year old boy with autistic disorder received 0.3 mg/kg of oral midazolam (but refused to drink all the preparation) and then 6 mg of IV midazolam. He also needed endodontic treatment for a first mandibular molar and exhibited scores of 3 or 4 throughout the session.
The type of dental treatment for which midazolam sedation was indicated was different between the groups (p<0,001, Pearson chi square test). More sessions for oral hygiene and scaling were undertaken in the group with ID and more conservative procedures (restorative or endodontic treatments) were performed for patients with DA (
Patients with DA | Patients with ID | ||
0 (0%) | 1 (0.6%) | ||
4 (3.3%) | 9 (5.2%) | ||
0 (0%) | 13 (7.5%) | ||
1 (0.6%) | 12 (6.9%) | ||
0 (0%) | 1 (0.6%) | ||
33 (27.5%) | 33 (19%) | ||
37 (30.8%) | 32 (18.4%) | ||
6 (5%) | 13 (7.5%) | ||
9 (7.5%) | 9 (5.2%) | ||
24 (20%) | 46 (26.4%) | ||
6 (5%) | 5 (2.9%) | ||
120 | 174 |
The distribution of the three levels of Venham score, at each time point and for each group, is presented in
The distribution of the three levels of Venham score, at each time point and for each group. Ti: At first contact with the dentist; T0: During venous cannulation; T1: At the end of the induction; T2: During the first injection of local anaesthesia; T3: At the moment of least cooperation during initial dental treatment. DA: Group of patients with Dental anxiety disorder; ID: group of patients with Intellectual Disability. *** = significant difference between the two groups of patients (p<0.001, Fisher exact test).
No major adverse event was recorded during the study. Minor side effects were recorded for 16.6% (31/187) of sessions in patients with ID and 6.8% (9/133) of sessions in patients with DA (p = 0.01, Fisher exact test) (
DA Group | ID Group | ||||
Respiratory (hyper- or hypo- ventilation; desaturation…) | 1 | 1 apnoea (5 seconds) | 8 | 8 desaturation lasting >30 seconds | |
Neurological (convulsions, epilepsy…) | 1 | 1 hiccups | 8 | 6 hiccups,1 epileptic fit,1 hallucination | |
Digestive (nausea, vomiting…) | 6 | 3 vomiting (all in one womanwith severe gag reflex) and3 episodes of nausea | 7 | 2 vomiting and 5 nausea | |
Behavioural (euphoria, excitability…) | 1 | 1 panic attack | 8 | 6 hyperexcitability and 1 episode of lip-biting under local anaesthesia | |
Vasovagal (sweating, pallor, faint…) | 0 | 0 | |||
A print-out of physiological parameters was available for 110 sessions in patients with DA and 160 sessions in patients with ID. In 53 sessions, the poor level of cooperation of patients with ID did not allow baseline physiological assessment before initial induction with IV midazolam.
In 34 sessions the recorded SpO2 fell below 90%. Of these sessions, 8/110 (7.3%) were in patients with DA and 26/160 (16.3%) concerned patients with ID (p<0.05 Fisher exact test). In half of these sessions, low SpO2 was recorded in the induction period. In some cases, low recorded SpO2 was related to loss of the pulse oxymeter sensor from the finger. In all cases, low recorded SpO2 was corrected clinically by repositioning the sensor and by using simple airway management techniques (repositioning the patient to facilitate ventilation). Oxygen was administered (2l/min) in three sessions (for two patients with ID and one patient with DA), during 17 minutes in one case and 10 minutes in the others. Flumazenil was administered at the end of the session for one patient with intellectual disability in order to facilitate behaviour management during the return journey to his special home. It was never necessary to summon additional medical assistance.
In 17 sessions (12/110 in patients with DA and 5/160 in patients with ID), the HR fell below the minimal normative value in relation to the age of the patient (
The SBP was below the minimal normative value at some point for 3 sessions (all in patients with ID) and was above the maximal normative value at some point for 72 sessions: 17/110 (15.5%) in patients with DA and 55/160 (34.4%) in patients with ID (p<0.001, Fisher Exact test). The DBP was below the minimal normative value at some point for 27 sessions (11/110 in patients with DA and 16/160 in patients with ID) (Non Significant, Fisher Exact test) and was over the maximal normative value at some point for 12 sessions (all in patients with ID).
The distribution of Ramsay scores at T4, T5 and T6 was different between patients with DA and patients with ID (p<0.001 at T4 and T6, and p<0.05 at T5, Pearson chi-square test) (
Patients with Dental Anxiety | Patients with Intellectual Disability | ||
Ramsay scale | Score | No. sessions (%) | No. sessions (%) |
20 (16.3) | 60 (34.9) | ||
96 (78) | 83 (48,3) | ||
7 (5.7) | 29 (16,9) | ||
0 (0) | 0 (0) | ||
0 (0) | 0 (0) | ||
0 (0) | 0 (0) | ||
15 (12.4) | 43 (25.7) | ||
92 (76) | 91 (54.5) | ||
13 (10.7) | 31 (18.6) | ||
0 (0) | |||
0 (0) | 0(0) | ||
11 (9.0) | 52 (30.8) | ||
99 (81.1) | 87 (51.5) | ||
12 (9.8) | 26 (15,4) | ||
0 (0) | |||
0 (0) | 0 (0) | ||
0 (0) | 0 (0) |
All patients subsequently recovered spontaneously without need for the use of flumazenil for reversal or additional medical assistance. However, all of these patients were contra-indicated for IV midazolam for future treatment as it was considered that the level of sedation necessary for treatment was over and above that of the self-imposed limit of conscious sedation
More sessions in the DA group were undertaken in patients with previous experience of the technique than for the group with ID (66.9% vs. 47.6%) (p<0.001, Pearson chi square test). The mean number of sessions per patient was 3.7±3.2 (min. 1, max. 16) for patients with DA and 2.3±2.4 (min. 1, max. 15) for patients with ID (p<0.001, t-test). When the sedation with intravenous midazolam was repeated, the rate of total and partial success combined increased significantly in patients with DA (from 92 to 99%, p<0.01 Fisher exact test) and remained statistically unchanged in patients with ID (from 96 to 99%). No influence of repetition on adverse events was found in either group. No influence of repetition on the dose of midazolam administered was found for either group (repeated measure procedure). For the repeated sessions in patients with DA, more sessions were conducted with a totally relaxed patient (Venham score of 0) at Ti (37.1% repetition vs. 14.6% first experience, p<0.01, Fisher exact test) and T1 (94.1% vs. 82.1%, p<0.05, Fisher exact test) (
The distribution of the three levels of Venham score, at each time point and for each group, in relation to the session being a first experience of sedation (First exp.) or a repeat session (Reit.). Ti: At first contact with the dentist; T0: During venous cannulation; T1: At the end of the induction; T2: During the first injection of local anaesthesia; T3: At the moment of least cooperation during initial dental treatment. DA: Group of patients with Dental Anxiety disorder; ID: group of patients with Intellectual Disability. Significant difference between the two groups of patients, Fisher exact test: *** = p<0.001, ** = p<0.01, * = p<0.05.
Conscious sedation procedures using intravenous midazolam administered with or without inhalation sedation (50% N2O2) or premedication were shown to be safe and effective in patients with intellectual disability as well as patients with dental anxiety disorder. This study is the first prospective clinical trial giving comparative data of conscious sedation for dental care in patients with intellectual disability and no influence of routine psychotropic treatment on the effectiveness or safety of the procedures used was found. In this study, thirty-eight sessions were performed in children and adolescents. More sessions would be necessary to allow a separate analysis of the young population.
The effectiveness of the conscious sedation could be partly explained by the flexibility of the approach used in order to address individual patient needs. In the vast majority of patients requiring premedication, the drug given was midazolam (per os or intrarectal) in order not to introduce multiple pharmacological effects (55/58 sessions). Inhalation sedation (50% N2O2) was used to allow cannulation and/or to deepen sedation without additional respiratory depression. The technique used was chosen in relation to each individual, in order to enable treatment with minimal distress at each step, from the beginning to the end of the care session. Effectiveness of the procedures also therefore depended on the ability of the operator/sedationist to evaluate and anticipate patient difficulties and behaviour prior to the session, according to the treatment required. The success rate of 89% showed that this procedure may be considered as an alternative to general anaesthesia for these patients, allowing comprehensive dental treatment and regular maintenance, as reported previously for this population
In over half of the sessions, inhalation sedation (50% N2O2) was used to reduce anxiety and nociception during cannulation, and then used throughout dental treatment if necessary. Previous studies conducted in children also showed that the association of nitrous oxide/oxygen with intravenous or oral midazolam enhances the effectiveness of the procedure
In this study, the adequate dose of intravenous midazolam, not counting any premedication, was close to that reported in other recent articles
In the present study, as in that undertaken by Ransford et al.
No major adverse event occurred during the study and no relationship was found between the incidence of minor adverse events and concomitant psychotropic treatment when present. However, more minor adverse events occurred in patients with ID than in patients with DA (16.6% versus 6.8% respectively). In a previous study in adults with disability using intranasal plus intravenous midazolam, 6.0% of adverse events were reported
Particular attentiveness is required for patients with disability as regards their physiological state during sedation. This study showed that the physiological parameters (minimal SpO2, maximal SBP and DBP) were outside of the normal range more often in these patients than in patients with dental anxiety disorder. The risk of serious complication is therefore higher in this population
The authors wish to thank Geneviève Traverse and Danièle Giral, nurses in the special dental care unit where this project was undertaken, for their assistance during the sedation sessions and Caroline Eschevins for her technical assistance during the manuscript production.