Conscious sedation by rectal administration of midazolam or midazolam plus ketamine as alternatives to general anesthesia for dental treatment of uncooperative children

The trial included 24 children (aged 2–7 yr) referred for dental treatment under general anesthesia, since conventional behavioral management methods had failed to achieve treatment acceptance. As an alternative, they received, on two separate occasions with "identical" dental treatment, conscious sedation by rectal administration of either midazolam (0.3 mg/kg body weight (bwt)) or midazolam (0.3 mg/kg bwt) plus ketamine (1.0 mg/kg bwt). This allowed a double-blind, crossover design. The aims were to assess conscious sedation, combined with local anesthesia, as an alternative to general anesthesia, and further to evaluate the effects obtained by addition of a low dose of ketamine to rectally administered midazolam. The feasibility of dental treatment was rated as excellent or good for 16 of the 24 children when premedicated with midazolam, and for 18 of the 24 children when ketamine was added to midazolam. At least some treatment could be given to all children. Verbal contact was maintained with all children throughout both treatment sessions. The children were significantly less anxious when they arrived for the second session. Amnesia and drowsiness were significantly increased when ketamine was added to midazolam. The combination also tended to be more efficient in relief of anxiety and prevention of pain, but there were large variations in the children's responses to the drugs. Midazolam significantly reduced the blood oxygen level, but not with ketamine added. For most children, both regimens proved to be appropriate as alternatives to general anesthesia. From a pharmacologic point of view, the combination of midazolam and ketamine appears to be reasonable because 1) both drugs have sedative and amnestic properties, 2) ketamine adds an analgesic component, 3) midazolam counteracts the psychic side-effects of ketamine, and 4) ketamine counteracts the depressive effects of midazolam on vital body functions (respiration and circulation).     

Intra-nasal midazolam in conscious sedation of young paediatric dental patients

Summary. Objectives . To compare the effects of 3 different doses of intra-nasal midazolam in the conscious sedation of young paediatric dental patients and to compare the effectiveness of the sedation in the fasting and non-fasting child.
Design . Double blind random controlled trial.
Sample and Methods . Thirty-eight uncooperative young children aged 2–5 years (mean age 4·02 years) were randomly assigned to one of 3 groups. The groups and the doses of midazolam administered intra-nasally were A: 0·3 mg/kg, B: 0·4 mg/kg, and C: 0·5 mg/kg body weight. Each child in each group had two visits for restorative treatment: one without food (fasting) and the other with soft drink and light food (non-fasting) before treatment. Child behaviour and sedative effects were evaluated using the scoring system of Houpt. The vital signs were monitored continuously using a pulse oximeter and Dinamap machine.
Results . There was rapid onset of sedation with the maximal effect between 8 and 15 minutes. This sedation lasted for 25–40 minutes in Groups A and B and for 60 minutes in Group C. Conscious sedation and dental treatment were achieved in 79%, 96% and 100% of the children in Groups A, B and C, respectively. Consistently higher Houpt scores were seen in Groups B and C, with statistically significant differences between Groups A and C, and B and C (Tukey's range test, P < 0·05). There were no significant differences in the general behaviour of the child, the onset and the duration of sedation between the fasting and the non-fasting child (nonparametric anova P > 0·05). All the vital signs were within normal physiological limits and there were no significant adverse effects either with or without fasting.
Conclusions . All 3 doses of intranasal midazolam were effective in modifying the behaviour of the uncooperative child patient to accept dental treatment. This was irrespective of fasting.     

Nasal versus oral midazolam sedation for pediatric dental patients

PURPOSE: The purpose of this study was to evaluate and compare intranasal (IN) and oral (PO) midazolam for effect on behavior, time of onset, maximum working time, efficacy, and safety for patients requiring dental care. METHODS: Forty anxious subjects (20 IN, 20 PO, Frankl Scale 3 and 4, ages 2-6 years, ASA I and II) were sedated randomly with either IN (0.3 mg/kg) or PO (0.7 mg/kg) midazolam. The dental procedure under sedation was videotaped and rated by a blinded and calibrated evaluator using Houpt's behavior rating scale. RESULTS: There was no statistical difference for overall behavior (F3,27 = 0.407; P = .749). The planned contrasts showed significant interactions between time and route (IN vs PO) between 25 and 30 minutes after starting sedation. The time of onset (P = .000) and the working time (P = .007) were significantly different between IN and PO midazolam. There were no statistically significant differences in vital signs (O2 sat, HR, RR, BP) between PO and IN (P = .595). IN subjects showed more movement and less sleep toward the end of the dental procedures, and faster onset time but shorter working time than PO. Vital signs were stable throughout the procedures with no significant differences. CONCLUSIONS: Mean onset time was approximately 3 times faster with IN administration compared to PO administration. Mean working time was approximately 10 minutes longer with PO administration than it was with IN administration. Overall behavior under PO and IN was similar. However, more movement and less sleep were shown in subjects under IN than those under PO toward the end of the dental session. All vital signs were stable throughout the procedures and showed no significant differences between PO and IN administration.     

Rectal administration of midazolam for conscious sedation of uncooperative children in need of dental treatment

The aim of this study was to determine the effects of rectal midazolam on uncooperative children. The trial included 120 children at the age of 16 months to 10 years and six months (X = 4.5 years). The children were referred because behavioural management techniques alone had failed. On 225 treatment occasions the children received midazolam, 0.3 mg/kg body weight rectally 10 mins before treatment. The degree of sedation was assessed by the dentists after 10, 15, 20, 45 and 60 minutes. 60% of the treatments were fulfilled without difficulty. 39.6% of the treatments could be performed with some difficulty and with the help of parents preventive holding. Only one mentally handicapped patient showed non-acceptance. No side effects were noted during the treatments. After 107 treatments the parents were asked about the total time their children seemed sedated. After two hours 86 children were still considered sedated but after three hours only four of them seemed effected by the drug. Midazolam has shown in this follow-up to be an effective and safe drug for premedication of infants in the stressed dental situation. The advantage to for example diazepam lies mainly in the shorter period of time of sedation.     

口服咪达唑仑治疗牙科恐惧症儿童的临床疗效观察

目的对牙科恐惧症儿童实施口服咪达唑仑镇静下的口腔治疗,评估治疗的安全性、有效性及其影响因素。方法选择在口腔科就诊的Frankl量表评分为1的有不良牙科治疗经历的30例患儿为研究对象,共进行了46人次的口服咪达唑仑（0.5～1.0 mg·kg-1）镇静下治疗。治疗时,记录患儿的心率、血氧饱和度、治疗内容及持续时间等。采用Houpt量表评估患儿治疗完成情况,治疗结束24 h后电话回访不良反应。结果46人次治疗中,患儿的生命体征平稳、安全,37人次（80.4％）完成了既定治疗,9人次（19.6％）镇静效果不理想,仅完成部分治疗。烦躁不安是术后最常见的不良反应。3岁以上儿童的治疗成功率高于3岁及以下儿童,性别、剂量和治疗内容与治疗成功率无关。结论口服咪达唑仑治疗牙科恐惧症儿童是一种安全有效的方法,3岁以上儿童的治疗效果较好。     

Comparison of the effectiveness of oral diazepam and midazolam for the sedation of autistic patients during dental treatment

PURPOSE: This study was undertaken to compare the effectiveness of oral diazepam and midazolam in sedating autistic patients during dental treatment. METHODS: The treatment regimen consisted of nitrous oxide/oxygen inhalation in conjunction with oral administration of either diazepam 0.3 mg/kg or midazolam 0.5 mg/kg in a cross-over design study of 13 subjects aged 5.8 to 14.7 years. A drug was classified as being effective when over 70% of the patients taking the drug were judged as "success" in all 3 behavioral criteria: (1) sleeping; (2) body movement; and (3) crying behaviors. The study was observed by an independent clinician with an intraexaminer reliability of 88%. RESULTS: For sleeping behavior, midazolam was found to be significantly more effective than diazepam as the duration of stimulation increased (P<.05). For the movement and crying behaviors, midazolam also proved to be significantly more effective from the start of treatment through the 35- and 40-min markers, respectively (P<.05). For the remainder of treatment, however, there was no statistically significant difference in these behaviors between the trials (P>.05). Diazepam and midazolam were rated as 77% and 100% successful, according to the overall behavior evaluation criteria (P=.02). CONCLUSIONS: Both diazepam and midazolam were shown to be effective sedative agents, successfully and safely used to sedate autistic patients for dental treatment. Midazolam was significantly more effective than diazepam in those portions of the procedure with increased stimulation.     

Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients

PURPOSE: The purpose of this study was to compare the effectiveness of midazolam (MDZ) alone to a combination of MDZ and hydroxyzine (MDZH) when sedating young children for dental treatment. METHODS: This was a prospective, double-blinded, crossover clinical study of young uncooperative children in need of at least 2 restorative visits. Twenty-eight children, ages 21 to 56 months, with a mean age of 36.6 months, participated in this study. The subjects were assigned randomly to receive either 0.5 mg/kg of oral MDZ 20 minutes prior to the beginning of dental treatment or the combination of 0.3 mg/kg oral MDZ with 3.7 mg/kg of hydroxyzine 30 minutes before treatment. The alternative drug regimen was administered at the second appointment. All subjects also received 50% nitrous oxide and were restrained with a papoose board. The child's behavior (quiet or crying, relaxed or moving) was evaluated every 5 minutes by an experienced pediatric dentist who was unaware of the drug given to the child. At the conclusion of treatment, each session was evaluated for overall effectiveness. RESULTS: Regardless of the type of premedication, more patients exhibited quiet behavior at the beginning of treatment, with an increase in crying and movement toward the end of treatment. Regarding movement, a significant difference was observed during the first 20 minutes between the 2 regimens. MDZ showed more children exhibiting movement. During the first 30 minutes of treatment, more children cried in the MDZ group, while MDZH presented more children asleep or quiet. No significant differences were found in behavior as a function of the order the sedative regimens were given. No significant differences between the 2 regimens regarding overall behavior and success (t=0.655 at 27 degrees of freedom; P=.518) were found. CONCLUSIONS: The combination of hydroxyzine (3.7 mg/kg) with MDZ (0.3 mg/kg) administered 30 minutes before treatment resulted in safe and effective sedation for the dental treatment of young children. This combination's use might be more advantageous when compared to MDZ alone, resulting in less crying and movement during the first 30 and 20 minutes, respectively.     

Outcomes of moderate sedation in paediatric dental patients

Background: The aim of this study was to evaluate the outcomes of moderate sedation with nitrous oxide/oxygen (N₂O/O₂) alone or combined with different dosages and administration routes of midazolam in uncooperative paediatric dental patients using the Bispectral Index System (BIS). Methods: This one‐year clinical study examined first‐visit moderate sedation performed in 240 healthy children aged 4–6 years. Subjects were randomly divided into four groups according to drug, route and dosage, as follows: Group 1 – 0.20 mg/kg midazolam (40 mg/ml) delivered intranasally; Group 2 – 0.75 mg/kg midazolam (15 mg/3 ml) delivered orally; Group 3 – 0.50 mg/kg midazolam (15 mg/3 ml) delivered orally. All children in these three groups also received inhalation sedation with 50%–50% N₂O/O₂, whereas children in Group 4 received inhalation sedation with 50%–50% N₂O/O₂ only. The outcome of sedation was evaluated as either ‘successful’, ‘failed’ or ‘not accepted’. Results: The highest success rate was found in Group 1 (0.20 mg/kg intranasally, 87%), followed by Group 2 (0.75 mg/kg orally, 79%). The overall mean success rate for all groups was 73%. Conclusions: Moderate sedation can be successfully used in the clinical management of paediatric dental patients, with both intranasal and oral sedation using midazolam in conjunction with nitrous oxide found to be effective methods.     

Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation

PURPOSE: The purpose of this retrospective record review of 2- and 3-year-old dental patients receiving intranasal midazolam (INM) was to compare drops vs spray administration to behavioral outcomes observed for agent acceptance during administration and for agent efficacy during parental separation, local anesthesia injection, and delivery of restorative dentistry. METHODS: Temperament and attachment scores based on adaptability and approachability determinants judged by the parent and interactive and Frankl behavior rating scores determined by the operator were used to compare preoperative behavioral characteristics between the 2 groups. The Ohio State Behavioral Rating Scale (OSBRS) and the Frankl behavior rating scale were used to determine intraoperative behavioral outcomes for agent acceptance and efficacy. RESULTS: Analysis of 64 sedation records revealed that the 2 groups had similar preoperative behavioral characteristics. Improvements in the Frankl behavioral rating scores were observed during the sedation, but no statistically significant difference between the drops and spray groups was measured using the OSBRS. For the procedural event of drug administration, however, the spray group demonstrated a statistically significant reduction (P=.025) in aversive behaviors when compared to drops administration as measured by the OSBRS. This finding was observed, even though the volume of spray was greater than used in the drops group. CONCLUSIONS: Spray administration of INM produced significantly less aversive behavior than administering drops in 2- to 3-year-old dental patients of similar behavioral characteristics. The effectiveness of the conscious sedation technique was not influenced by the method of nasal administration. This study suggested that the use of a commercially available atomizer improved patient acceptance of INM administration but did not influence agent efficacy compared to drops administration for 2- to 3-year-old dental patients in an office setting.     

Rehabilitation of a fearful dental patient with oral sedation: utilizing the incremental oral administration technique

The treatment of fearful or anxious patients presents a myriad of problems for the dentist. In-office sedation using oral (enteral) medications is an effective means of increasing patient tolerance of invasive dental procedures. The incremental oral administration technique is a protocol that can be utilized to treat fearful or anxious patients. A case is presented in which this technique was used as an adjunct to the rehabilitation of a debilitated mouth.     

Nitrous oxide-oxygen or oral midazolam for pediatric outpatient sedation

OBJECTIVE: A total of 1112 pediatric outpatient sedations, by either nitrous oxide-oxygen inhalation (N2O) or oral midazolam, administered over a 10-year period were reviewed. Patient responses and outcomes were evaluated to ascertain the safety of these sedation techniques. STUDY DESIGN: A total of 819 patients were included in this study. Patient health status, age, weight, behavior, treatment rendered, and length of treatment were recorded. Vital signs (heart rate, blood pressure, oxygen saturation) were recorded for the N2O group. Complications and successful completion of treatment were also noted. RESULTS: Both the N2O and midazolam groups demonstrated a low complication rate with a high rate of successful completion of treatment. Patients receiving N2O were somewhat older on average and underwent a greater number of surgical procedures than patients in the midazolam group. Vital signs recorded in the N2O group were observed to remain stable throughout treatment. CONCLUSIONS: The use of either oral midazolam or nitrous oxide-oxygen as single agents provides safe and effective conscious sedation in the pediatric outpatient population.     

Comparison of dexmedetomidine and midazolam for conscious sedation in dental surgery monitored by bispectral index

Although various sedative drugs in different regimens and given by different delivery routes have been used for conscious sedation, the ideal agent and regimen remain to be established. This study was designed to compare the efficacy (sedation, anxiolysis, analgesia, operating conditions, and patients’ satisfaction) and safety of midazolam and dexmedetomidine as sedatives for dental procedures in a randomised, double-blind study in third molar and dental implant surgery. Sixty healthy patients who were American Society of Anesthesiologists (ASA) group I or II were enrolled and we recorded their personal details, the amount of drug used, their degree of satisfaction, duration of operation, and haemodynamic and respiratory variables. The two groups were comparable. The amount of local anaesthetic (p = 0.11) and the duration of operation did not differ significantly (p = 0.32). The patients in the dexmedetomidine group had a slower heart rate, lower systolic and diastolic pressure, and cooperated better. There were no significant differences in their respiratory rates, bispectral index, and total volume of drugs used. We conclude that dexmedetomidine works as well as midazolam for outpatient dental procedures and can be used as an alternative to midazolam.     

Comparison of oral midazolam with oral tramadol, triclofos and zolpidem in the sedation of pediatric dental patients: An in vivo study

Objective: oral sedation is the simplest and most convenient sedation method for managing uncooperative child patients because it is easy to administer and there is no need for nasal hood or injection. Oral midazolam is the most commonly used preanesthetic medication for children. When given in amounts between 0.5 and 0.75 mg/kg of body weight, oral midazolam has been found to be an effective sedative agent for pediatric outpatients. Tramadol is a synthetic, centrally acting analgesic indicated for moderate to severe pain. Chloral hydrate is one of the sedatives most commonly used, has excellent absorption, fast induction, and exert minimal effects on respiration. zolpidem is the most commonly prescribed hypnotic due to its clinical efficacy, safety, and ability to be well tolerated with patients. Materials and Methods: 60 anxious and fearful children who reported to the department were treated under conscious sedation for the accomplishment of dental treatment. Patients were randomly assigned to four groups. Statistical analysis was done using Kruskal Wallis Test and decision criterion was to reject the null hypothesis if the P-value is less than 0.05. Results: it was observed that there is a statistically significant difference in median scores recorded for the level of sedation between the different groups (P < 0.001). Conclusion: this study concluded that midazolam is the best drug for producing conscious sedation followed by tramadol and triclofos. Zolpidem was not able to produce a sufficient level of sedation and it cannot be supported as a sedative agent at the present dosage.