Comparison of oral ketamine and oral midazolam as sedative agents in pediatric dentistry

The safe and effective treatment of uncooperative or combative preschool children with extensive dental needs is one of pediatric dentist's ongoing challenges. The traditional methods of behavior management are no longer acceptable to parents as they are not ready to spare more time for dental treatment of their children. Keeping this in mind, the present study was designed and carried out to evaluate the sedative effects of oral ketamine and oral midazolam prior to general anesthesia. Twenty uncooperative children in the age-group of 2-6 years were selected after thorough medical examination and investigations. Informed consent was obtained from the parent. This was a randomized double-blind study. An anesthesiologist administered either 0.5 mg/kg midazolam or 5 mg/kg ketamine orally. The heart rate, respiratory rate, and oxygen saturation were recorded at regular intervals. The sedation and anxiolysis scores were also recorded. The parents were asked to answer a questionnaire at the follow-up session the next day on the surgical experience of the parent and the child and side effects experienced, if any. When the data was subjected to statistical analysis, it was observed that both drugs resulted in adequate sedation at the end of 30 min, with oral midazolam providing significantly better anxiolysis. The heart rate and respiratory rate were marginally higher with oral ketamine. The questionnaire revealed a better response with oral midazolam; side effects were more prominent with oral ketamine.     

Randomised Comparative Study on Propofol and Diazepam as a Sedating Agent in Day Care Surgery

Objective

The study was conducted to assess the usefulness by qualitative comparison between the two intravenous sedative drugs, Diazepam and Propofol and to provide sedation in apprehensive and uncooperative patients undergoing day care oral surgical procedures.

Methods

The present study was conducted on 20 adult patients, 10 in each group (Propofol and Diazepam) irrespective of age and sex. Intravenous sedation of Propofol compared with Diazepam in terms of onset of action, recovery, and anterograde amnesia, patient co-operation, surgeon’s convenience and side effects and other parameters.

Results

Propofol was found to be the superior sedating agent compared to Diazepam, having rapid onset and predictability of action, profoundness of amnesia and a faster recovery period, offering advantages of early patient discharge and better patient compliance.

Conclusion

Propofol was found to be an ideal sedating agent in day care oral surgical procedures.     

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.     

Evaluation of the effect of nitrous oxide and hydroxyzine in controlling the behavior of the pediatric dental patient.

This study evaluated and compared the effect of three different sedation combinations on the young dental patient: hydroxyzine alone, hydroxyzine with nitrous oxide, and nitrous oxide alone. Nineteen uncooperative children with mean age of 37 months needing at least three restorative visits were selected for this study. Crying, alertness, and general behavior were evaluated during the dental procedure. The combination of hydroxyzine and nitrous oxide was more effective than the others for the majority of the sessions in terms of controlling crying and alertness. The results in the present study indicate that the sedative effect of hydroxyzine on children's behavior is enhanced by the addition of nitrous oxide.     

A comparison of two meperidine/hydroxyzine sedation regimens for the uncooperative pediatric dental patient

PURPOSE: The purpose of this study was to compare the safety and efficacy of submucosal-administered meperidine (SM) and oral-administered meperidine (OM). Both regimens were used in conjunction with oral hydroxyzine for the sedation of children for dental treatment. METHODS: Twenty preschool-age children, with previous histories of uncooperative behavior, were randomly assigned to first receive a sedation regimen of either SM (0.5 mg/ lb), or OM (1 mg/lb), both with oral hydroxyzine (0.5 mg/lb). A cross-over design was utilized so that each child received both regimens. Safety was monitored through vital signs and side effects. Efficacy was measured with Houpt and Frankl behavior ratings. RESULTS: Vital signs remained stable during both treatments. Differences noted were clinically insignificant. The major side effects reported during submucosal injection included pain (58%) and edema (26%). All blinded behavior ratings, in both sedation regimens, significantly improved from presedation Frankl ratings. No significant differences existed between treatments. Success was 63% in the SM group and 80% in the OM group. The percentages were not statistically significant (P=.219). CONCLUSIONS: Both methods of administration were found to be safe and effective for sedating uncooperative pediatric dental patients. Neither was significantly more effective or safer than the other.     

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 evaluation of newer sedatives in conscious sedation

This double blind study was undertaken to determine the safety and efficacy of orally administered newer sedatives and analgesics for conscious sedation in 120 child patients. Patients were randomly assigned into: Midazolam (I), Ketamine (II), Zolpidem (III), Midazolam plus Ketamine (IV), Midazolam plus Tramadol (V) and Zolpidem plus Tramadol (VI) groups of 20 each. Onset of action, level of sedation, ease of treatment completion, recovery time, and post-operative amnesia were assessed for all and compared. Midazolam plus ketamine was found the most effective combination providing a fast and adequate analgo-sedation in anxious and uncooperative child patients.     

Clinical evaluation of the effects of ketamine sedation on pediatric dental patients.

This study was undertaken to determine the dosages, treatment times and side effects of ketamine HCI with and without two benzodiazepines when used for sedation on a group of precooperative children at the UCLA Children's Dental Center. Ketamine was evaluated when used alone, and in conjunction with two benzodiazepines, diazepam or a new water-soluble midazolam. An anti-muscarinic, atropine or glycopyrrolate, and nitrous oxide-oxygen were included in all sedations. Mean treatment times were increased significantly when ketamine and a benzodiazepine were used in combination. Additionally, mean ketamine dosages were decreased significantly when ketamine was utilized in combination with a benzodiazepine. All children tolerated the sedation well and there were no severe adverse reactions. Side effects included nausea, vomiting, and a rise in post-operative temperatures.     

A study of the effectiveness of oral midazolam as a dental pre-operative sedative and hypnotic

Orally administered Midazolam at dosages of 0.5, 0.6, and 0.75 mg/kg was used with 34 healthy, uncooperative pediatric dental patients. Effective pre-operative sedation occurred within approximately 15 minutes with a 30- to 40-mlnute duration of action. Blood pressure and respiration remained stable throughout. The numbers and types of procedures performed were dependent on the degree of sedation, the behavior of the patient, the experience of the operator, and the operator's ability to administer the medication. The ideal dosage appears to be 0.6 mg/kg, with an average change of 1.43 Frankel Units in behavior modification. A dosage of 0.5 mg/kg appears to yield erratic results, while a dosage of 0.75 mg/kg offers little advantage with greater potential for adverse reactions. The oral administration of Midazolam for pediatric patients with extreme behavioral problems, such as Attention Deficit Hyperactive Disorder, was of little advantage and may produce an idiosyncratic reaction. Midazolam's quick onset and short duration of action, coupled with its ideal properties of sedation, relaxation, and amnesia, offer a viable alternative for treating the anxious, uncooperative pediatric dental patient .     

右美托咪定与几种镇静药物在口腔门诊手术中镇静效果的meta分析

目的:采用meta分析,比较右美托咪定与咪达唑仑、氯胺酮和安慰剂在口腔门诊手术中的镇静效果。方法:计算机检索PubMed、Embase、Cochrane Library、Web of Science,检索时间从建库至2017年10月。收集口腔门诊手术中比较右美托咪定与咪达唑仑、氯胺酮或安慰剂镇静效果的随机对照试验（RCT）。采用Cochrane协作网系统评价法评价纳入文献质量,采用RevMan5.3软件对收集的患者资料进行meta分析。结果:共纳入12篇RCT、678例患者。Meta分析结果显示,右美托咪定组儿童的镇静评分低于生理盐水组(SMD=-1.73,95%CI:-2.70~-0.77,P=0.0004);右美托咪定组成人的镇静评分也低于生理盐水组(SMD=-2.23,95%CI:-4.39~-0.08,P=0.04);右美托咪定组儿童的镇静满意度与氯胺酮组无显著差异（RR=1.14,95%CI：1.00~1.30,P=0.05）;右美托咪定组儿童的镇静满意度优于咪达唑仑组（RR=1.38,95%CI：1.15~1.67,P=0.0006）;右美托咪定组成人的镇静满意度与咪达唑仑组无显著差异（RR=1.42,95%CI：0.86~2.33,P=0.17）;并且右美托咪定组儿童的行为满意度优于氯胺酮组（RR=1.19,95%CI：1.03~1.36,P=0.01）,也优于咪达唑仑组（RR=1.28,95%CI：1.07~1.54,P=0.008）。结论:与其他镇静药物相比,右美托咪定用于口腔门诊手术适度镇静可能是一种更好的选择。     

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.     

丙泊酚静脉维持麻醉用于婴幼儿唇裂手术的临床应用

目的:婴幼儿唇裂手术中,应用丙泊酚与传统的氯胺酮静脉麻醉方法比较。方法:Ⅰ～Ⅱ度唇裂手术婴幼儿55例,男34例,女21例;平均体重(8.3±2.5)kg。全部患儿均采用气管插管全麻。将患儿随机分为两组,Ⅰ组(氯胺酮组n=29),Ⅱ组(丙泊酚组n=26)。结果:Ⅰ组拔管时间、清醒时间明显较Ⅱ组长(P<0.05),且躁动哭闹人数、术后恶心呕吐发生率明显高于Ⅱ组(P<0.05)。结论:丙泊酚用于婴幼儿唇裂修复术,具有苏醒快、气道分泌物少、术后恢复安全系数高的特点。而氯胺酮+γ-羟基丁酸钠麻醉,具有诱导插管平稳,但术后苏醒延迟、恶心呕吐、躁动哭闹发生率较高等特点,尤应注意术后呼吸道的管理。     

A comparison of two oral ketamine-diazepam regimens for the sedation of anxious pediatric dental patients.

PURPOSE: This study compared 2 oral ketamine-diazepam regimens (8 mg/kg and 10 mg/kg of ketamine in combination with 0.1 mg/kg diazepam) in preschool age children with respect to physiological, behavioral and amnestic parameters. METHODS: Twenty-five children completed the double-blind, crossover design. Physiologic, behavioral and amnestic effects were evaluated. RESULTS: ANOVA demonstrated significant changes in systolic blood pressures and heart rates in both the 8 mg/kg group and 10 mg/kg group (P < 0.05), as well as significant changes in diastolic blood pressures in the 10 mg/kg group (P < 0.05). However, these changes were not clinically significant. Success rates were 28% for the 8 mg/kg dosage and 44% for the 10 mg/kg dosage. There was a cumulative vomiting rate of 50% and a psychic phenomena rate of 10%. There were no statistically significant differences between the two dosages with regard to success rates, postoperative vomiting, or psychic phenomena using McNemar's test. CONCLUSIONS: There is no advantage of 10 mg/kg dose of ketamine over the 8 mg/kg dose. Ketamine did not demonstrate amnestic effects in this study. There were statistically but no clinically significant changes in physiological parameters in either group. This study does not support the use of either 8 mg/kg or 10 mg/kg oral ketamine for the sedation of uncooperative children.     

Comparison of triazolam to a chloral hydrate/hydroxyzine combination in the sedation of pediatric dental patients

The purpose of this study was to compare the effectiveness of triazolam to chloral hydrate with hydroxyzine when sedating young children for dental treatment. Twenty children, age 21 to 74 months, with a mean age of 44 months, were given triazolam. Twenty children, age 23 to 64 months, with a mean age of 42 months, were given chloral hydrate with hydroxyzine. The children were given an elixir of either .02 mg/kg triazolam or 40 mg/kg chloral hydrate with 25 mg hydroxyzine. All subjects received 50% nitrous oxide and were restrained with a Papoose Board. The sedations were videotaped and evaluated by two pediatric dentists not involved in the study. They rated the success of the sedations by degree of sleep, crying, body movements, and overall behavior. Time until onset of action of the agents given, oxygen saturation of arterial blood, and heart rate were measured. The vital signs were consistent for the two groups. There was no statistical difference in the effectiveness of sedation between the two groups.     

Lachgassedierung in der Kinderzahnheilkunde

Inhalational sedation with nitrous oxide is a safe and effective method of managing fear and pain and it is widely used in pediatric dentistry. It is suitable for treating children with low-grade to moderate fear of dental treatment but cannot be used in extremely fearful or uncooperative patients. A modern generation of nitrous oxide equipment is easy to use and minimizes the risk of environmental exposure to the gas. By integrating suggestion and colorful, scented nasal hoods, children’s already high approval ratings for the method increases even further. Other benefits include rapid onset and offset of the sedative effect, precise control of the duration and depth of sedation and a short recovery period. Dentists can acquire all the necessary theoretical and practical knowledge for performing dental inhalation sedation in 2-day courses led by anesthesiologists.     

Effect of submucosal midazolam on behavior and physiologic response when combined with oral chloral hydrate and nitrous oxide sedation

PURPOSE: This study was designed to examine the efficacy and safety of submucosal (SM) midazolam and oral chloral hydrate (CH) when used for pediatric conscious sedation in a clinical dental environment. METHODS: Twenty children ages 32 to 63 months participated in this institutionally approved study. Selection criteria included good health (ASA I), 2 to 5 years of age, uncooperative behavior, and the need for multiple restorative visits. In a double-blind crossover design, patients were randomly assigned to receive either oral CH (50 mg/kg) and SM midazolam (0.2 mg/kg), or oral CH (50 mg/kg) and SM saline placebo on their first sedation visit. On the second sedation visit, the patient received the opposite drug regimen than the first visit. Nitrous oxide (50%) was used during each sedation visit. Behavior response was rated as quiet (Q), crying (C), movement (M), or struggling (S) every 2.5 minutes through 40 minutes of operative procedures. Sedations were monitored using a capnograph, pulse oximeter, an automated blood pressure cuff, and precordial stethoscope. Respiratory rate (RR), heart rate (HR), and blood pressure (BP) were evaluated for each procedure. Data was analyzed using ANOVA and multinomial repeated-measures logistic regression. RESULTS: Analysis showed a significant difference in behavior during sedation across drug regimen (chi-square = 55.6, df = 3, P < .0001). Patients given SM midazolam in addition to oral CH showed increased Q rating and decreased C, M, and S ratings. RR, BP, and HR for both groups remained within the normal values for 2- to 5-year-olds. CONCLUSIONS: SM midazolam improved the quality of sedation without compromising safety. Quiet behavior was increased and struggling behavior was decreased. In addition, mean HR, RR, and BP analysis did not deviate from the norm for this age group.     

水合氯醛两种途径在小儿口腔治疗前镇静效果的探讨

目的：探讨不同途径水合氯醛给药在小儿口腔治疗前的镇静效果。方法：对120例2～4岁无法有效配合治疗的患儿随机分为两组于口腔治疗前采取10%水合氯醛口服和10%水合氯醛灌肠而后进行口腔治疗。结果：口服组发生胃肠道反应的有13例,灌肠组0例。两组比较有统计学意义（P〈0.01）。灌肠组药物起效时间明显快于口服组,两组比较有统计学意义（P〈0.01）。镇静效果灌肠组优于口服组,两组比较有统计学意义（P〈0.01）。镇静维持时间两组有明显差异（P〈0.01）。结论：对于行为管理无效的小儿口腔治疗前采用水合氯醛镇静是一种安全有效的方法,若能采取灌肠则比口服效果更佳,从而为不能配合的患儿的口腔治疗提供较好的技术支持。     

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).     

Comparitive Evaluation of Propofol and Midazolam as Conscious Sedatives in Minor Oral Surgery

Objective

The objective of the study was to assess the efficacy of propofol and midazolam as an intravenous sedative agent in minor oral surgical procedures in terms of: (a) the onset of action, (b) heart rate, (c) oxygen saturation, (d) systolic and diastolic blood pressure, (e) respiratory rate, (f) pain during the injection of sedative agent, (g) recovery period, (h) side effects, (i) patient’s cooperation during the surgery.

Methodology

This was a double blind randomized study in which one group of 20 patients received propofol with the induction dose of 0.5 mg/kg and 50 μg/kg/min which was administered by syringe infusion pump as a maintenance dose and the other group received midazolam in a single dose of 75 μg/kg and no maintenance dose was given, instead 5 % dextrose was administered by syringe infusion pump at the rate of 50 μg/kg/min. Since propofol was milky white in colour, a green cloth was covered over the infusion pump in all cases. The surgeon, assistants and observers were blind about the medications which would be given to the patient for sedation. After the administration of the sedative, local anesthesia was achieved with 2 % lignocaine hydrochloride.

Results

The onset of action in propofol group was significant as onset of action was faster. The maximum increase in heart rate in propofol group was at 10 min intraoperatively (Mean ± 80.40 ± 12.73) and that in midazolam group was at 15 min intraoperatively (Mean 79.25 ± 13.44). Post operatively the heart rate decreased near to the baseline value in both the groups. The average oxygen saturation before induction in propofol group was 99.7 ± 0.73 % and that of midazolam group was 99.15 ± 01.31 P = 0.314. None of the patients in this study developed apnea. The systolic blood pressure (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives. The diastolic blood pressure (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives and the decreased diastolic blood pressure was maintained throughout the procedure. The respiratory rate (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives. The decreased respiratory rate remained throughout the surgical procedure. Pain during the injection of the sedatives was reported by nine patients (45 %) in the propofol group whereas none of the patients in midazolam group complained of pain during the injection. This is statistically significant (P = 0.001). The recovery time (Mean ± SD) in propofol group was 22.50 ± 3.04 (range 15–25 min) and that in midazolam group was 33.75 ± 3.93 (range 30–40 min), which was statistically significant (P < 0.001). Patients in the propofol group were significantly less co-operative than midazolam group at both 10 and 25 min intra operatively.

Conclusion

The design of the present study permitted qualitative assessment of propofol and midazolam as sedative agents in minor oral surgical procedures. The ideal anesthetic agent should provide rapid onset of action, profound intra operative amnesia while ensuring rapid recovery without much complications. There were no significant differences in either patient demographics or surgical characteristics between the two groups. The propofol group was less co-operative than midazolam group. Pain during the injection of sedative was a significant adverse effect in the propofol group. Cardiovascular parameters remained stable throughout the procedure in both study groups and no intervention was required. However recovery and onset of action was faster in the propofol group as compared with the midazolam group.     

Comparison of a chloral hydrate/hydroxyzine combination with and without meperidine in the sedation of pediatric dental patients

The purpose of this study was to compare the effectiveness of a chloral hydrate/hydroxyzine combination with and without meperidine in the sedation of pediatric dental patients. Twenty children were given 40 mg/kg chloral hydrate and 25 mg hydroxyzine, and 20 children were given 40 mg/kg chloral hydrate and 25 mg hydroxyzine and 0.5 mg/kg meperidine. All children were between the ages of 24 and 60 months and all medications were given orally 1 hr before treatment. The children received 50% nitrous oxide for the entire procedure. All children were restrained in a Papoose Board. The patients were videotaped and their behavior was rated by two independent pediatric dentists using the Houpt Scale. The independent evaluators did not know which sedation regimen had been used. They rated success of the sedations by degree of sleep, crying, body movements, and overall behavior. Oxygen saturation of arterial blood, and heart rate also were measured. The vital signs were consistent for the two groups. There was no significant difference in the effectiveness of the two drug regimens.