Rectal sedation with diazepam or midazolam during extractions of traumatized primary incisors: a prospective, randomized, double-blind trial in Swedish children aged 1.5-3.5 years.

The aim of this study was to compare rectal sedation with diazepam and rectal sedation with midazolam with regard to sedative effect, treatment acceptance, and amnesia. Ninety children, 1.5-3.5 years of age, consecutively referred for extractions of traumatized primary incisors were randomly sedated with diazepam (0.7 mg/kg body weight) or midazolam (0.3 mg/kg body weight). The study design was randomized and double-blind. The level of sedation (state of mind) was assessed prior to and 10 and 60 min after administration of the drug by use of a behavioral scale (Wilton). The children's acceptance of procedures was assessed using another behavioral scale (Holst) during administration of the sedative, application of topical anesthesia, injection of a local anesthesia, and extraction. Amnesia was evaluated by the parents on the following day, with the child being asked standardized questions. Parental ratings of the child's and their own distress during and after treatment were made on a visual analog scale (VAS). No differences were found between the sedatives concerning level of sedation during treatment, acceptance of procedures, or amnesia. At discharge, 60 min after administration of the sedative, the children receiving diazepam were significantly more agitated (P=0.006). Parental rating on a VAS of the child's discomfort after treatment was significantly higher in the diazepam group (P=0.006). There was a tendency for children with poor acceptance of the rectal administration to display a more negative acceptance of the dental treatment. In conclusion, the present results, in combination with known pharmacological advantages, indicate that midazolam is preferable in outpatients when sedation is needed and amnesia is desirable.     

Temperament and acceptance of dental treatment under sedation in preschool children

The major aim of the study was to investigate whether differences concerning acceptance of dental treatment and amnesia after rectal sedation with midazolam can be explained by temperament traits in the child. Fifty children (1.5-4.0 years), consecutively referred for dental extractions because of dental trauma or caries, were sedated with midazolam 0.3 mg kg^-1 rectally. Level of sedation (state of mind) was assessed according to Wilton before and 10 min after administration of the sedative. The children's acceptance of procedures during the oral examination, the administration of the sedative, and the dental treatment were assessed according to Holst. Acceptance of an injection of local anesthesia and tooth extraction was dichotomized as satisfactory (n = 26) or unsatisfactory (n = 24). The parent assessed temperament using the Emotionality Activity Sociability (EAS) Scale of Child Temperament. Amnesia was evaluated by the parent on the following day. The relation between temperament and outcome variables was analyzed using a multiple logistic regression analysis. Children regarded as shy by the parent were at significantly greater risk of unsatisfactory acceptance of the dental treatment (P < 0.05). High scores of negative emotionality were significantly related to less amnesia (P < 0.05). We conclude that parental ratings of their child's temperament are valuable in predicting a child's acceptance of dental treatment under sedation.     

Temperament and acceptance of dental treatment under sedation in preschool children

The major aim of the study was to investigate whether differences concerning acceptance of dental treatment and amnesia after rectal sedation with midazolam can be explained by temperament traits in the child. Fifty children (1.5 4.0 years), consecutively referred for dental extractions because of dental trauma or caries, were sedated with midazolam 0.3 mg kg(-1) rectally. Level of sedation (state of mind) was assessed according to Wilton before and 10 min after administration of the sedative. The children's acceptance of procedures during the oral examination, the administration of the sedative, and the dental treatment were assessed according to Holst. Acceptance of an injection of local anesthesia and tooth extraction was dichotomized as satisfactory (n = 26) or unsatisfactory (n = 24). The parent assessed temperament using the Emotionality Activity Sociability (EAS) Scale of Child Temperament. Amnesia was evaluated by the parent on the following day. The relation between temperament and outcome variables was analyzed using a multiple logistic regression analysis. Children regarded as shy by the parent were at significantly greater risk of unsatisfactory acceptance of the dental treatment (P< 0.05). High scores of negative emotionality were significantly related to less amnesia (P < 0.05). We conclude that parental ratings of their child's temperament are valuable in predicting a child's acceptance of dental treatment under sedation.     

Acceptance of dental care following early extractions under rectal sedation with diazepam in preschool children

The aim of the study was to evaluate the effect of amnesia in preschool children on their later acceptance of dental care. Forty-six 4-6-year-old children, who between 2 and 4 years previously had had primary incisors extracted because of trauma, were reexamined for dental health and acceptance of dental care. The extractions had been performed under rectal sedation with diazepam (0.7 mg/kg body weight). Information about dental treatment and degree of cooperation during the intervening period was obtained from records at the referring clinic. The parents were interviewed about their child's experience of amnesia concerning the extractions, background variables, and experiences of dental care before the follow-up examination. Amnesia concerning the extractions was reported in 85% of the children. Twenty-nine percent had on some occasion exhibited behavior management problems (BMP) during the intervening period. Lack of amnesia was significantly associated with BMP (P &lt; 0.002). Children without amnesia concerning the extractions tended to accept dental care less well at the reexamination. Parents were able to predict their child's acceptance of dental care at the follow-up with a significant degree of success (P = 0.02). In conclusion, amnesia in preschool children concerning extractions seems to be essential to facilitate positive acceptance of future dental care.     

Comparison of sedation,amnesia, and patient comfort produced by intravenous and rectal diazepam

In a cross-over study, intravenous diazepam was compared with rectal diazepam for sedation in outpatient oral surgery. Fifty-four operations were performed on 27 patients. Recovery from sedation, experience during the postoperative course, amnesia, estimation of the sedative effect, and patient preference of method of sedation were studied. The recovery times of the sedation methods did not differ. Sedative effects after the first operation were estimated as good by 87% of patients given intravenous sedation and by 75% of those given rectal sedation. However, there was a significant relationship between the subjective experience of stronger sedative effect and preference of sedation method that favored the intravenous technique. The degree of amnesia was significantly higher during intravenous sedation, but a high degree of amnesia was not related to patients' preference for a sedation method. Neither sedation method produced any local side effects.     

Midazolam, diazepam, and placebo as intravenous sedatives for dental surgery

This study was a comparison of the sedative and amnestic properties of midazolam and diazepam when administered for relief of patient discomfort during dental surgery. It was a double-blind placebo-controlled group study, which entailed the analysis of 60 patients randomly assigned to the three groups: midazolam, diazepam, and placebo. There were 20 patients in each group. Midazolam patients showed superior performance in the parameters of sedation and amnesia when compared to patients who were administered diazepam. Both groups showed better results than the placebo group, which had the best results with the Digit Symbol Substitution Test and the Trieger Test.     

A comparative evaluation of oral midazolam with other sedatives as premedication in pediatric dentistry

The purpose of present study was to evaluate the safety and efficacy of orally administered midazolam in children as a sedative agent and to compare it with two other older agents, triclofos and promethazine. The study was conducted on ninety child patients requiring some short dental procedure. All the patients were with a good physical status (ASA-I). The ages ranged between 3 and 9 years. The patients were randomized into three study groups: Group 1, midazolam, Group II, triclofos and Group III, promethazine, on the basis of the drugs to be administered. After administration of drugs in each group, the effects were evaluated in terms of onset of action, sedative effect, ease of treatment completion, recovery time and postoperative amnesia. Midazolam was found to be the best drug among the three to produce conscious sedation in children.     

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).     

Intravenous or rectal diazepam for outpatient sedation in minor oral surgery

In a randomized cross-over study on sedation in outpatient oral surgery, intravenous and rectal administration of diazepam were compared. The mean dose for intravenous diazepam was 0.22 mg X kg-1 (range 0.15-0.38) and for rectal diazepam 0.58 mg X kg-1 (range 0.50-0.71). The determining factors for the patients' preference for sedation method, apprehension, effect produced by the sedative, recovery from sedation and the postoperative course were studied. The patients preferred the session in which they experienced stronger effect, regardless of the route of administration. Patient preference for sedation method did not differ when optimal dose regimens were used, and a preset dose of 10 mg rectal diazepam did not produce the desired effect. Apprehension was significantly higher prior to and during the first operation than the second operation, and all patients recovered from sedation within 2 1/2 hours after the administration.     

Combined oral midazolam–ketamine better than midazolam alone for sedation of young children: a randomized controlled trial

International Journal of Paediatric Dentistry 2013; 23: 207–215 Background. There is a lack of clinical trials on paediatric dental sedation. Aim. We investigated whether young children’s behaviour improves during dental treatment with oral ketamine/midazolam compared with midazolam alone or no sedation. Design. Healthy children under 36 months of age, presenting early childhood caries were randomly assigned to receive protective stabilization plus: combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), or oral midazolam (1.0 mg/kg) (MS), or no sedative (PS). One observer scored children’s behaviour using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analysed using nonparametric bivariate tests. Results. Forty‐one children were included. In the dental exam session, the sum of OSUBRS scores was similar for the three groups (P = 0.81). In the treatment session, the MK produced more cooperative behaviour than MS and PS (P = 0.01), longer sessions (P = 0.04), and a pattern of homogeneous OSUBRS scores from the reception area (before sedative administration) to the end of the session (P = 0.06). No immediate and post‐discharge side effects were observed in groups MK and MS. Conclusions. The combination of oral midazolam and ketamine is efficacious for guiding the behaviour of children under 3 years old.     

The use of temazepam elixir in surgical dental sedation: a comparison with intravenous midazolam.

Out-patients attending for removal of at least one lower third molar were randomly allocated to treatment with temazepam elixir (n = 7) or intravenous midazolam (n = 8), as well as local analgesia. Patients were tested prior to drug administration and at the end of surgery. Both drugs increased heart rate and midazolam also decreased diastolic blood pressure. The two drugs caused significant, equal increases in ratings of sedation, but the reduction of anxiety was significant only for midazolam. There was significant amnesia for material presented after drug administration, as well as for dental events and this was significantly greater for midazolam. The effects of these drugs in dental patients were compared with those in normal volunteers treated in an identical manner, but without oral surgery. The drugs had similar significant cardiovascular and amnesic effects in the volunteers and the same effects on mood ratings, even though volunteers and patients differed in their pretreatment levels of anxiety and discontent. The dentist's ratings of the sedation and operating conditions were excellent in both cases. Thus temazepam elixir provided a useful sedative for oral surgery, avoiding the complications of intravenous administration. However, for equivalent levels of sedation, midazolam had greater anxiolytic and amnesic effects than temazepam.     

Conscious sedation by oral administration of midazolam in paediatric dental treatment

Midazolam is a short-acting benzodiazepine with rapid onset, short duration of action and minimal side effects. The aim of this study was to evaluate the oral administration of midazolam as pre-operative sedation in the dental treatment of uncooperative pediatric patients. Included in the study were 160 children with a mean age of 6.7 +/- 2.6 years (1-14 years), 83 boys and 77 girls. All the patients had been referred for specialist treatment due to behavioral management problems. Treatment was performed in 250 sessions. All the children received an oral dose of 0.2 mg/kg body weight of midazolam. Acceptance of treatment was evaluated according to Rud & Kisling. Local anesthesia followed by restorative treatment and/or extractions constituted more than 90% of the performed treatments. Of the 250 sessions, 63% were performed with total acceptance and 30% with doubtful acceptance. In 7%, no treatment could be performed. No serious complications were registered during or after treatment. All the children were able to leave the clinic one hour after treatment. In conclusion, we consider oral administration of midazolam a safe form of premedication. The route of administration, the short waiting-time and half-life, in combination with a level of sedation that allows treatment to be performed, are the principal advantages of conscious sedation with orally administered midazolam.     

A comparative study of intravenous diazepam and midazolam for oral surgery

Intravenous diazepam was compared with intravenous midazolam for conscious sedation in a single-blind study of 50 Hong Kong Chinese patients acting as their own controls. Verrill's sign was used as the end-point of sedation, and bilateral, similarly impacted lower third molars served as the surgical model. The drugs produced comparable levels of sedation, stable vital signs, and good operating conditions in all patients. Midazolam had numerous advantages over diazepam: more rapid onset of sedation, less pain during injection, profound anterograde amnesia, and fewer postoperative complications. The incidence of thrombophlebitis was low with both drugs and appears to be so in Chinese in general. A significant majority of the patients preferred sedation to other techniques and midazolam to diazepam.     

Assessment of intranasal midazolam administration with a dose of 0.5 mg/kg in behavior management of uncooperative children

AIM: Intranasal midazolam has been used to induce conscious sedation in children with negative and aggressive behavior The main goal of this study was to determine the effectiveness of intranasal administration of midazolam (with a dose of 0.5 mg/kg) in behavior management of uncooperative children. MATERIALS AND METHODS: Thirty healthy, difficult children of 3-5 years were evaluated. At the beginning of each session, ordinary techniques of behavior management to treat patients were applied. In cases of unsatisfactory responses, intranasal midazolam was immediately employed. To determine the efficacy of the drug, child behavior was evaluated before and after administration of midazolam using Houpt rating scale of general behavior. RESULTS: A statistically significant difference was demonstrated in the patients 'behavior before and after administration of intranasal midazolam. CONCLUSIONS: this drug is effective in sedation and reduction of the anxiety of children under treatment.     

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.     

盐酸咪达唑仑镇静药在阻生智齿拔除术中应用的临床观察

目的观察马来酸咪达唑仑（midazolam HCl）静脉输注提高下颌阻生智齿拔除时患者舒适度的效果。方法50例双侧下颌阻生智齿拔除难度基本相同的患者，采用自身对照设计，一侧采用盐酸咪达唑仑低流量（平均流量0．042±0．010mg·kg^-1）静脉输入，另一侧空白对照。结果试验组焦虑视觉模拟量表（visual analogue scale，VAS）平均得分21．4±12．2mm，疼痛VAS平均得分（6．92±9．50）mm，与对照组（35．9±18．2）mm；（16．4±12．4mm）比较，差异有统计学意义（P=0．000；P=0．000）。结论在拔除阻生智齿时，对轻度恐惧的患者应用盐酸咪达唑仑镇静，可以显著提高患者的舒适度。     

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.     

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.     

Effects of intravenous midazolam and diazepam on patient response, percentage of oxygen saturation, and hemodynamic factors during periodontal surgery

BACKGROUND: The purpose of this double-masked study was to evaluate effects of intravenous sedation (IVS) using midazolam or diazepam during periodontal procedures on patient recall, psychomotor response, oxygen saturation, and hemodynamic factors. METHODS: Seventeen patients received either two or three scheduled periodontal surgeries under IVS with midazolam, diazepam, or placebo control. Patients were monitored throughout the procedure for hemodynamic variables, percent oxygen saturation, level of recall of common objects presented at baseline, and psychomotor function via the perceptual speed test (PST). RESULTS: Fifteen patients completed the study with average titrated dosages of 3.3 and 12.1 mg for midazolam and diazepam, respectively. Within the limitations of the study, there were few differences observed between the drugs with regard to hemodynamic variables, oxygen saturation, and overall percentage of objects recalled by patients sedated with either drug. However, midazolam was found to cause a greater incidence of amnesia lasting up to 30 minutes when compared to placebo. Patients on diazepam required an average of 15 minutes longer to recover accuracy as measured by the PST. CONCLUSIONS: The results suggest that diazepam and midazolam each may have advantages for IVS. In procedures lasting over 45 minutes, diazepam appears to be more clinically advantageous including a wider margin of safety during titration and gradual recovery. Midazolam may be used for shorter procedures for faster onset of action, predictable amnesic effects, and relatively rapid recovery.     

口服与肌注咪达唑仑镇静治疗儿童牙科焦虑症的临床疗效对比

目的:评估咪达唑仑口服或肌注两种不同给药方法对牙科焦虑症患儿牙科治疗时的镇静效果。方法:将2020年1月~2020年7月于深圳市儿童医院口腔科接受咪达唑仑镇静下牙齿治疗的90例患儿随机分为两组,每组45例。肌注组给予肌注咪达唑仑(0.2 mg/kg),口服组给予口服咪达唑仑(0.6 mg/kg,单次最大剂量20.0 mg)。采用Ramssay量表评估患儿镇静情况,Frankl量表评估患儿治疗依从性,Houpt量表评估患儿治疗完成情况。同时记录药物起效时间、患儿治疗过程中的心率、血氧饱和度、术中及术后不良反应情况等。结果:肌注组起效时间(13.0±2.0)min明显短于口服组(15.6±1.8)min,差异有统计学意义(t=6.489,P<0.05)。两组的Ramssay量表评分中位分值(Z=-1.089,P=0.276),Frankl量表评分中位分值(Z=-0.0863,P=0.388)及Houpt量表评分中位分值(Z=-1.854,P=0.064)差异无统计学意义(P>0.05),评分分布相似。两组患儿的镇静成功率(χ^2=0.178,P>0.05)及治疗成功率(χ^2=3.103,P>0.05)差异无统计学意义(P>0.05)。两组不良反应发生率差异无统计学意义(χ^2=0.080,P>0.05)。结论:口服或肌注咪达唑仑镇静效果相似,是治疗牙科焦虑症患儿的安全有效的镇静方法,但肌注组的镇静起效更快。