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.     

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.     

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.     

Amnesia,pain experience,and patient satisfaction after sedation with intravenous diazepam

Recovery time, the effect of sedation or amnesia on postoperative pain, and patients' opinions of the sedation were studied. Forty operations were performed on 20 patients. Each patient had four impacted third molars removed in two sessions, one in which a new emulsion form of diazepam (Diazemuls^®) was used, and one in which no sedation was used. The recovery from sedation was found to be very individual and not related to the dose administered, as assessed by a simple, easy-to-use method. There was no difference in postoperative pain between the sedated and unsedated groups, and we found no correlation between postoperative pain and amnesia. Eighty-five per cent of the patients preferred sedation during surgery, even though none of them had a preoperative indication for sedation.     

Oral clonidine pre-treatment and diazepam/meperidine sedation

Clonidine has recently been used as a pre-operative medication and sedative/anxiolytic drug. Its extended duration of action makes it suitable for longer procedures. In this randomized, crossover, placebo-controlled clinical trial, we characterized the effects of oral clonidine pre-treatment on intravenous diazepam/meperidine sedation using the bi-spectral index (BIS) in 13 participants. Clonidine significantly increased the numbers of BIS-depressed readings and percent memory loss during sedation, while reducing total diazepam and post-operative analgesic dosages by 44% and 55%, respectively. Systolic, diastolic, and mean arterial blood pressures, as well as pulse rates, were reduced. Respiratory rate, oxygen saturation, end-tidal CO(2), and recovery from sedation were unchanged. Participants, surgeons, and sedationists preferred clonidine over the placebo. Clonidine pre-treatment increased and prolonged sedation and amnesia and stabilized vital signs while significantly decreasing diazepam and post-operative analgesic usage. These results suggest that pre-operative clonidine administration could be a useful supplement to intravenous sedation for dental procedures of long duration.     

An evaluation of the amnesic effects of diazepam sedation

Twenty subjects, 13 female and 7 male, aged 16 to 37 years, were studied to determine the effects on memory of intravenous sedation with diazepam (Valium). Three tests were performed: 1) the Weschler Logical Memory Scale; 2) memory of three geometric shapes; and 3) memory of three objects presented in a drawing. Logical memory items were presented before and after sedation; other tests were presented after sedation. Anterograde amnesia was produced by diazepam sedation. No retrograde amnesia was observed. A significant drug effect was found between the pre-drug and post-drug retention intervals (T+ = 2; P less than 0.005). Post-drug recognition scores were found to be approximately 42% of pre-drug recognition scores. The anterograde amnesia produced with diazepam was probably due to decreased arousal of the subject, and decreased attention to rehearsal of short-term memory stimuli, resulting in a lack of storage of the stimuli.     

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.     

Efficacy of oral midazolam prior to intravenous sedation for the removal of third molars.

The combination of oral and intravenous sedation has not been well investigated and this study examined the combination's effect on amnesia, anxiety, cardiovascular stability and recovery in a double blind, cross-over, placebo controlled trial. Patients were given 7.5 mg oral midazolam or placebo 1 h prior to intravenous midazolam and surgery. This investigation demonstrated significant anxiolysis, amnesia and patient preference for oral midazolam compared to placebo. There was no significant effect on cardiovascular stability, the intravenous dose of midazolam used or post-operative recovery. Low dose oral midazolam prior to intravenous sedation may be beneficial in very anxious patients, particularly if surgery is delayed.     

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.     

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 < 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.     

A comparison of chloral hydrate and diazepam sedation in young children

The purpose of this study was to compare a high and low dose of diazepam with chloral hydrate in the sedation of young children. Thirty healthy children between the ages of 20 and 48 months, with a mean age of 33.5 months, participated in the study. All children exhibited negative behavior during a screening visit and required at least two restorative appointments with the use of sedation. A dose of either 0.3 mg/kg or 0.6 mg/kg of diazepam at one visit and 50 mg/kg of chloral hydrate at another visit was administered in a double-blind manner. All children were restrained in a Papoose Board with auxiliary head restraint and received 50% nitrous oxide/oxygen during treatment. The degree of sleep, body movement, crying, pulse rate, respiratory rate, and blood oxygen saturation were monitored before and during the operative procedures. Vital signs remained essentially unchanged during treatment, except for transitory elevations of the pulse during periods of stimulation. There were no statistically significant differences among the three drug regimens with regard to movement and crying. Significantly more patients who received chloral hydrate were asleep than when either dose of diazepam was given during the first 60 min of treatment. The only side effect found was vomiting in one patient with both chloral hydrate and diazepam. It is concluded that the sedative effects of chloral hydrate and diazepam are similar when young children are sedated for dental treatment. The use of diazepam might be more advantageous because chloral hydrate produces more sleep during the first hour of treatment.     

A study of anxiety, and midazolam-induced amnesia in patients having lower third molar teeth extracted

We studied 60 patients to find out whether anxiety affects the dose of midazolam necessary for sedation, and whether operating time, dose of midazolam, or technique have any influence on levels of amnesia and anxiety. A pilot study preceded the main study in which 20 patients were given local anaesthesia only and 20 local anaesthesia and intravenous sedation. Patients in the main study group (n = 60) received both local anaesthesia and intravenous sedation. The dose required for sedation was not linked to amnesia, pulse rate, blood pressure, or preoperative anxiety. Sedation did significantly reduce postoperative anxiety scores, (P< 0.001) and amnesia was affected by operating time; complete surgical amnesia seemed to last about 25 minutes.     

Dexmedetomidine versus midazolam in outpatient third molar surgery.

PURPOSE: The aim of this study was to compare the use of dexmedetomidine with the use of midazolam during intravenous conscious sedation in third molar surgery. PATIENTS AND METHODS: Twenty healthy patients with symmetrically impacted mandibular third molars were included in this double-blind, crossover, randomized study. Either dexmedetomidine (group D) (4 microg.kg(-1).h(-1)) or midazolam (group M) (0.4 mg.kg(-1).h(-1)) was administered intravenously for 15 minutes before the first operation. At the second operation, the other agent was applied. Cardiorespiratory data were collected. The intraoperative sedation level, patient cooperation, and postoperative performance were scored and any pain reaction during the local anesthetic injection was recorded. Visual analog scales were additionally used for the subjective assessment of pain and patient satisfaction. Amnesia was evaluated by the patients' ability to recall the objects shown during the operations and the local anesthetic injection. Patients' preferences were recorded during the interview at the end of the second operations. RESULTS: The mean heart rate and blood pressure measurements were significantly lower in group D. There was no significant difference in the respiratory findings. A significantly higher number of patients showed pain reactions in group M. Sedation level, postoperative performance, and VAS pain scores were not statistically significant, whereas the differences in cooperation score and VAS for patient satisfaction were significant. Adequate amnesia was obtained in group M, however, no amnesia was demonstrated in group D. Sixty-five percent of the patients indicated a preference for dexmedetomidine sedation. CONCLUSION: Dexmedetomidine may be a remarkable alternative to midazolam for intravenous sedation because it seems to be a reliable and safe method, with additional analgesic effect providing a satisfactory sedation level without any serious side effects during impacted third molar surgery.     

Double-blind comparison of nalbuphine and meperidine in combination with diazepam for intravenous conscious sedation in oral surgery outpatients

Nalbuphine and meperidine were compared as analgesic components of intravenous conscious sedation in a double-blind, prospective trial of 47 patients undergoing elective oral surgery. Subjects were evaluated for pain intensity, pain relief, anxiety, sedation, recall, and vital signs at systematic observation points intraoperatively and postoperatively. At the conclusion of surgery 83% of patients who had received nalbuphine and 86% of patients treated with meperidine indicated complete pain relief. One observed adverse reaction was attributed to meperidine and another to the sedative component diazepam. No statistically significant differences were observed between nalbuphine and meperidine treatments.     

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.     

笑气吸入清醒镇静法用于拔牙术的临床研究

目的总结笑气吸入清醒镇静法用于拔牙术的临床效果。方法实验组１１２例，随机分为四组，在笑气吸入清醒镇静辅以局部麻醉下拔牙。对照组５１例，仅在局部麻醉下拔牙。结果实验组术后有７４．１１％患者焦虑评分下降，与对照组相比，两者手术前后焦虑变化差异有非常显著性（Ｐ＜０．０１）。实验组均获得一定程度的镇静，６７．８６％患者部分遗忘。大多数患者（８６．６１％）接受笑气吸入清醒镇静。实验组四组间手术前后焦虑变化情况、镇静评分、健忘评分差异无显著性（Ｐ＞０．０５）。结论笑气吸入清醒镇静具有较好的抗焦虑、镇静、健忘作用，能够减轻或解除患者的焦虑心理，减少非牙科焦虑患者产生医源性牙科焦虑心理。     

Evaluation of patient-controlled remifentanil application in third molar surgery.

PURPOSE: The aim of this study was to evaluate the clinical efficacy and safety of patient-controlled remifentanil application in combination with intravenous (IV) midazolam sedation during third molar surgery. PATIENTS AND METHODS: Twenty healthy patients with symmetrically placed impacted bilateral mandibular third molars were included in this prospective, placebo-controlled, double-blind, cross-over, randomized clinical study. A bolus dose of 0.05 mg/kg intravenous midazolam was applied to each patient. Remifentanil was administered (group MR) by patient controlled infusion (PCI) either in the first or the second operation. In the other operation, a placebo (group MP) was given in the same manner. Perioperative blood samples were obtained to determine the changes in the stress hormone (aldosterone, adrenocorticotropic hormone [ACTH], renin) levels. Vital signs and oxygen saturation were recorded. Ramsey's sedation scale and modified Steward's recovery scale was used for evaluation of consciousness. Pain, patient satisfaction, cooperation score, reaction to local anesthetic injection, and degree of amnesia were also assessed. RESULTS: Remifentanil significantly increased the level of sedation, patient cooperation, and satisfaction; decreased the oxygen saturation, heart rate, and pain. While renin levels were significantly different, ACTH and aldosteron levels did not differ significantly between the 2 groups. Aldosterone and ACTH levels significantly decreased, whereas the renin level significantly increased in both groups during the operations. Remifentanil did not significantly alter the recovery time. CONCLUSION: Patient-controlled remifentanil application in combination with IV midazolam sedation seems to be a safe and reliable method, which effectively eliminates pain and provides a satisfactory sedation level, without any serious side effect.     

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。     

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.     

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.