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.     

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.     

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.     

Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients

PURPOSE: The purpose of this retrospective study was to compare the effects of oral administration of a combination of chloral hydrate (CH) 25 mg/kg, hydroxyzine (H) 1 mg/kg, and meperidine (M) 1 mg/kg to midazolam 0.65 mg/kg using 50% nitrous oxide (N2O) on behavioral and physiological parameters of young children sedated for dental procedures. Factors associated with sedation effectiveness were identified, including age, preoperative behavior, and type of procedure. METHODS: Records of 116 sedation sessions of 66 healthy, uncooperative children ages 24 to 60 months at The University of Iowa Centers for Disabilities and Development were reviewed. Patients received 1 of the 2 regimens. Intraoperative behavior was rated using a dichotomous scale. Physiological variables including heart rate and oxygen saturation were recorded at baseline and at 10-minute intervals of the session. Data were analyzed using SPSS Version 9. RESULTS: Overall, 81 % of sessions were rated successful. Sedation sessions using CH+H+M combination had significantly higher success rate (P<.01, odds ratio=3.38, 95% confidence interval= 1.06 to 7.15) compared to sessions with midazolam. Sedation success was not associated with age, preoperative behavior, or type of dental procedure performed. Physiological variables were within the normal range for both regimens, although midazolam regimen recorded higher heart rates. CONCLUSIONS: CH+H+M combination using 25 mg/kg CH resulted in significantly more effective sedation sessions compared to midazolam. Both regimens used 50% N2O and were found to be safe.     

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 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.     

BIS monitoring during midazolam and midazolam-ketamine conscious intravenous sedation for oral surgery

OBJECTIVE: The purpose of this study was to determine whether the bispectral index scale (BIS) would provide added benefit to established methods of monitoring conscious sedation with midazolam (M group) or midazolam supplemented with ketamine (MK group). STUDY DESIGN: BIS was prospectively and blindly examined in 22 patients receiving outpatient oral surgery with conscious sedation supplemented with local anesthesia. RESULTS: The average midazolam dose in the midazolam group over the treatment period was 0.01 mg/kg/h, and the average midazolam plus ketamine dose was 0.01 and 0.05 mg/kg/h, respectively. Mean BIS values throughout the sedation study period were 90 for the midazolam group and 94 for the midazolam plus ketamine group. The addition of ketamine did not lower BIS. BIS values did not alter significantly over time except for an expected transient drop after the midazolam bolus induction. CONCLUSION: BIS levels remained close to baseline levels, suggesting that BIS would not provided any additional benefit to currently established methods of monitoring patient consciousness during conscious sedation for oral surgery.     

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.     

不同镇静药对口腔颌面外科术后留置气管导管患者的镇静作用

目的: 探讨不同镇静药对口腔颌面外科术后留置经鼻腔气管导管患者的镇静作用及其可能的不良反应。方法: 将60例口腔颌面外科术后留置经鼻腔气管导管患者按随机数字表法为3组,每组20例。患者入ICU后,各组患者均采用氢吗啡酮镇痛,分别采用咪达唑仑、丙泊酚和右美托咪定镇静,分别记录入ICU镇静前(T₀)和镇静开始后30 min(T₁)、1 h(T₂)、2 h(T₃)、6 h(T₄)、12 h(T₅)和拔管后10 min(T₆)各时间点Ramsay镇静评分和BPS镇痛评分以及生命体征;记录各组患者不良反应发生率。采用SPSS 19.0软件包对数据进行统计学分析。结果: 咪达唑仑、右美托咪定和丙泊酚Ramsay评分差异无统计学意义(P>0.05)。在T₃、T₄、T₅时,右美托咪定组BPS评分均显著低于咪达唑仑组和丙泊酚组(P<0.05)。3组患者低血压发生率差别无统计学意义(P>0.05);心动过缓发生率右美托咪定组显著高于与丙泊酚和咪达唑仑组(P<0.05);右美托咪定组和丙泊酚组患者并发躁动的人数显著低于咪达唑仑组(P<0.05)。结论: 右美托咪定和咪达唑仑、丙泊酚均能满足ICU患者的镇静需要,且右美托咪定具有一定的镇痛作用,可减少ICU患者躁动发生率。     

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 various physiologic and psychomotor parameters in patients sedated with intravenous lorazepam, diazepam, or midazolam during oral surgery

Intravenously administered lorazepam (0.05 mg/kg), diazepam (0.25 mg/kg), and midazolam (0.1 mg/kg) were compared for sedation during oral surgery under local anesthesia. Sixty patients were randomly allocated into three groups in this double-blind, parallel study. The results from this trial show that all three drugs provide satisfactory sedation. Average mean arterial pressures, however, decreased significantly with midazolam and diazepam. Statistically significantly higher heart rates during the entire procedure were also found for lorazepam when compared with diazepam and midazolam. At the postblock stage, the midazolam group had respiratory rates that were significantly higher than those of the other two drug groups. Patients in the diazepam and midazolam groups took significantly longer to complete the pegboard test at the preblock stage than those in the lorzepam group. At 1, 1.5, and 2 hours after arrival in the recovery room, an inversion of groups took place, with the lorazepam group taking significantly longer for their tests than the other two groups. Significantly more improvement in anxiety levels was found at 10 minutes postdrug for the patients who had received diazepam and this tended to remain so on arrival in the recovery room. When compared with the other two groups, significantly more patients in the lorazepam group reported giddiness/dizziness and significantly more in the diazepam group reported pain on injection.     

Comparison of the efficacy of oral midazolam alone versus midazolam and meperidine in the pediatric dental patient

PURPOSE: The purpose of this study was to compare midazolam alone (Group A: 1 mg/kg) vs midazolam plus meperidine (Group B: 0.5 and 1 mg/kg, respectively) in regard to physiology and behavior of young children sedated for dental restorative care. METHODS: Twenty healthy children who met selection criteria were randomly assigned to 1 of 2 groups and subsequently treated in a prospective, crossover design. All sedative agents were administered orally, and all sedations included 50% nitrous oxide administered via a nasal hood. Heart rate, systolic and diastolic blood pressure, and behavior were recorded at 8 procedural or time periods during the visits. Chi-square and ANOVA were used to analyze the data. RESULTS: No difference in physiology or behavior was found between groups. However, higher heart rates and disruptive behaviors occurred more frequently during or after local anesthesia administration. CONCLUSIONS: Oral midazolam alone is just as effective as midazolam with meperidine. Disruptive behaviors accounted for increased heart rates.     

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.     

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.