A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide/sevoflurane. An RCT pilot study to test the effects of intravenous midazolam as a conscious sedation technique for anxious children requiring dental treatment--an alternative to general anaesthesia. Effectiveness of premedication agents administered prior to nitrous oxide/oxygen. A double-blind randomized comparison of midazolam alone and midazolam combined with ketamine for sedation of pediatric dental patients. A comparative evaluation of oral midazolam with other sedatives as premedication in pediatric dentistry. Midazolam premedication in children: a pilot study comparing intramuscular and intranasal administration. The therapeutic effectiveness of nitrous oxide and chloral hydrate administered orally, rectally, and combined with hydroxyzine for pediatric dentistry. Patient-administered nitrous oxide/oxygen inhalation provides effective sedation and analgesia for colonoscopy. A double blind randomized comparison of oral trimeprazine-methadone and ketamine-midazolam for sedation of pediatric dental patients for oral surgical procedures. Efficacy and acceptabilty of oral-transmucosal midazolam as a conscious sedation agent in pre-school children. Comparison of triazolam to a chloral hydrate/hydroxyzine combination in the sedation of pediatric dental patients. Oral midazolam as premedication for the apprehensive child before dental treatment. Comparison of two different dosages of hydroxyzine for sedation in the paediatric dental patient. Sedation in uncooperative children undergoing dental procedures: a comparative evaluation of midazolam, propofol and ketamine. 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. Comparison of sevoflurane and nitrous oxide mixture with nitrous oxide alone for inhalation conscious sedation in children having dental treatment: a randomised controlled trial. Evaluation of oral or rectal midazolam as conscious sedation for pediatric patients in oral surgery. Parental presence during induction enhances the effect of oral midazolam on emergence behavior of children undergoing general anesthesia. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. A comparison of three doses of a commercially prepared oral midazolam syrup in children. Comparison of three conscious sedation regimens for pediatric dental patients. Conscious sedation--an artist's science! An Indian experience with midazolam. Sedation, topical pharyngeal anesthesia and cardiorespiratory safety during gastroscopy. Safety and effectiveness of intranasal administration of sedative medications (ketamine, midazolam, or sufentanil) for urgent brief pediatric dental procedures. Evaluation of oral midazolam as conscious sedation for pediatric patients in oral restoration. A comparative evaluation of newer sedatives in conscious sedation. Oral midazolam is an effective premedication for children having day-stay anaesthesia. A comparison of oral clonidine and oral midazolam as preanesthetic medications in the pediatric tonsillectomy patient. A randomized double-blind trial of chloral hydrate/hydroxyzine versus midazolam/acetaminophen in the sedation of pediatric dental outpatients. Placebo-controlled trial of midazolam sedation in mechanically ventilated newborn babies. Premedication with melatonin vs midazolam in anxious children. Nasal versus oral midazolam sedation for pediatric dental patients. The efficacy of oral clonidine premedication in the prevention of postoperative vomiting in children following strabismus surgery. Midazolam sedation in mechanically ventilated newborns: a double blind randomized placebo controlled trial.
Failure of dental treatment due to anxiety is a common problem in children. The aim of this study was to establish whether the use of a combination of intravenous midazolam with inhalation agents (nitrous oxide alone or in combination with sevoflurane) was any more likely to result in successful completion of treatment than midazolam alone. A further aim was to evaluate the clinical viability of these techniques as an alternative to general anaesthesia. In total, 697 children too anxious for management with relative analgesia and requiring invasive dental procedure for which a general anaesthetic would usually be required, were recruited and randomly assigned to one of three groups given the following interventions: group 1 - a combination of inhaled medical air and titrated intravenous midazolam, group 2 - a combination of inhaled 40% nitrous oxide in oxygen and titrated intravenous midazolam, and group 3 - a combination of an inhaled mixture of sevoflurane 0.3% and nitrous oxide 40% in oxygen with titrated intravenous midazolam. The primary outcome measure was successful completion of the intended dental treatment with a co-operative child responsive to verbal commands. In group 1, 54% (94/174 children) successfully completed treatment. In group 2, 80% (204/256 children) and in group 3, 93% (249/267 children) completed treatment. This difference was significant at the 1% level. Intravenous midazolam, especially in combination with inhaled nitrous oxide or sevoflurane and nitrous oxide, are effective techniques, with the combination of midazolam and sevoflurane the one most likely to result in successful treatment. To add to the evidence base for acceptable and effective paediatric conscious sedation techniques in dental primary care.
                To compare three conscious sedation techniques for primary care as an alternative to dental general anaesthesia (DGA) in children. To assess the feasibility and practicality of running the trial in general dental practice. To form the basis for sample size calculations and assess scales of measurement.
                Single centre, randomised control trial (RCT).
                Queensway Anxiety Management Clinic (QAMC). A primary care based general and referral dental practice for the management of anxious patients.
                Sixty five children too anxious for management with relative analgesia, requiring invasive dental procedure for which dental general anaesthesia (DGA) will be required if an alternative cannot be found.
                Group 1 (n = 20) - A combination of inhaled medical air and titrated intravenous midazolam. Group 2 (n = 22) - A combination of inhaled 40% nitrous oxide in oxygen and titrated intravenous midazolam. Group 3 (n = 23) - A combination of an inhaled mixture of 0.3% sevoflurane and 40% nitrous oxide in oxygen with titrated intravenous midazolam.
                Successful completion of the intended dental treatment with a child who is co-operative and responsive to verbal commands.
                Fifty per cent (ten children) successfully completed treatment in Group 1, 73% (16 children) in Group 2 and 83% (19 children) in Group 3. This difference was not significant at a 5% level (chi(2) = 5.53, df = 2, P = 0.07) Of the total of 20 failures, eight children in Group 1 and one child in Group 2 were successfully treated with the addition of sevoflurane and nitrous oxide in oxygen. Only two children required referral to a hospital setting for DGA and the remaining nine children were managed with an alternative conscious sedation technique.
                This pilot shows that intravenous midazolam especially in combination with the addition of inhaled nitrous oxide or sevoflurane and nitrous oxide were promising safe and effective techniques, sufficient to justify progression to a definitive RCT with appropriate methods. In paediatric dentistry, when anxiety, fear of dental procedures or behavioural impairment precludes the conduct of dental treatments, sedation procedures are required. However, sedation at the desired level might not be achieved despite administration of various agents. The present study aimed to evaluate the effectiveness of oral premedication with different agents on children scheduled for dental treatment under nitrous oxide/oxygen (N2O/O2) sedation.
                The present research was approved by the Ethics Committee of Gazi University Faculty of Medicine. Sixty children aged between 5 and 8 years, ASA I or II, having no mental or motor retardation, requiring at least two-visit dental treatment, having no sedation or general anaesthesia experience, and incompliant with dental treatment (Frankl Behaviour Scale>or=3), were enrolled into the study after obtaining informed parental consent. The children were then randomly assigned to one of four groups. The treatment regimen according to the study groups was as follows: oral administration of 1 mg kg(-1) hydroxyzine hydrochloride suspension (Atarax) 1 h preoperatively (group I, n=15), oral administration of 0.7 mg kg(-1) midazolam (Dormicum) 15 min preoperatively (group II, n=15), oral administration of 3 mg kg(-1) ketamine (Ketalar) with 0.25 mg kg(-1) midazolam (Dormicum) 15 min preoperatively (group III, n=15), and no oral premedication administration [group IV (controls), n=15]. Peripheral oxygen saturation (SpO2) and heart rate were monitored with a pulse oximeter during treatment. The sedation level was monitored with the bispectral index. Following premedication, 40% N2O and 60% O2 was administered to all groups by means of a nasal mask. Sedation depth was evaluated using the Ramsay Sedation Scale and data were recorded at 5 min intervals. Sedation success and other sedation-related events were recorded.
                The evaluation of the findings of this study revealed that treatment procedures were completed without any serious complications. Achievement of sedation in terms of satisfactory/mid-level satisfactory/unsatisfactory was as follows: 13.3/53.3/33.3% in group I; 54/20/26% in group II; 33.3/33.3/33.3% in group III, and 6.7/60/33.3% in group IV, respectively. Ramsay Sedation Scale results revealed that the most effective medication was 0.7 mg kg(-1) midazolam.
                It is concluded that 0.7 mg kg(-1) midazolam is more effective than 0.25 mg kg(-1) midazolam with 3 mg kg(-1) ketamine and 1 mg kg(-1) hydroxyzine hydrochloride in terms of oral premedication prior to N2O/O2 sedation in children scheduled for dental treatments. The safety and efficacy of a new sedation technique for children having dental procedures under local anesthesia were evaluated.
                One hundred children between the ages of 2 and 7 years who required sedation for dental procedures were administered either a combination of midazolam (0.35 mg/kg) and ketamine (5 mg/kg) or midazolam alone (1 mg/kg) rectally 30 minutes before removal to the dental chair. Pulse rate, respiratory rate, arterial pressure, oxygen saturation, adverse reactions, postoperative recovery, and behavior were recorded.
                Satisfactory sedation and anxiolysis were achieved with both drugs used in the study. When evaluating postoperative recovery, statistically significantly more children receiving midazolam alone were fully awake on admission to the recovery room and 30 minutes later. Results of physiologic monitoring, behavioral ratings, and adverse effects are reported. Excessive salivation occurred in 26% of children receiving the combination of drugs, compared with 14% receiving midazolam alone. Seven (14%) of the children receiving the combination of drugs hallucinated, compared with 21 (42%) receiving midazolam alone. Both drug groups had reliably good anxiolysis and sedation without loss of respiratory drive or protective airway reflexes.
                The use of a combination of midazolam and ketamine or midazolam alone is a safe, effective, and practical approach to managing children for minor dental procedures under local anesthesia. With this technique, advanced airway management proficiency is recommended. 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. The purpose of this study was to compare the effectiveness of intramuscular and intranasal midazolam used as a premedication before intravenous conscious sedation. Twenty-three children who were scheduled to receive dental treatment under intravenous sedation participated. The patients ranged in age from 2 to 9 years (mean age, 5.13 years) and were randomly assigned to receive a dose of 0.2 mg/kg of midazolam premedication via either intramuscular or intranasal administration. All patients received 50% nitrous oxide and 50% oxygen inhalation sedation and local anesthetic (0.2 mL of 4% prilocaine hydrochloride) before venipuncture. The sedation level, movement, and crying were evaluated at the following time points: 10 minutes after drug administration and at the times of parental separation, passive papoose board restraint, nitrous oxide nasal hood placement, local anesthetic administration, and initial venipuncture attempt. Mean ratings for the behavioral parameters of sedation level, degree of movement, and degree of crying were consistently higher but not significant in the intramuscular midazolam group at all 6 assessment points. Intramuscular midazolam was found to be statistically more effective in providing a better sedation level and less movement at the time of venipuncture than intranasal administration. Our findings indicate a tendency for intramuscular midazolam to be more effective as a premedication before intravenous sedation. This study compared the effectiveness of three pediatric sedation modalities when they were used with nitrous oxide. Comparisons were based on a subjective evaluation of the overall quality of the sedation technique and data obtained from a pulse/oximeter. Oral administration of 50 mg/kg of chloral hydrate was the least effective modality. In a double-blind, randomized, placebo-controlled study of patients undergoing colonoscopy, sedation with an inhaled mixture of nitrous oxide/oxygen was compared with conventional intravenous sedation (pethidine 50 mg, midazolam 2.5 mg). In the patients studied, no significant differences were noted in number of pain episodes, need for additional intravenous sedation, or patient pain scores between the group receiving the nitrous oxide/oxygen mixture (n = 30) and those managed with conventional benzodiazepine/opiate injection (n = 29). Both methods were significantly more effective than placebo (n = 30). Six patients in the benzodiazepine/opiate group had oxygen desaturation, whereas none did in the nitrous oxide/oxygen group. Duration of stay after the procedure was significantly shorter in the gas inhalation group than in those receiving conventional intravenous sedation. Except for patients with severe chronic obstructive pulmonary disease, nitrous oxide/oxygen inhalation is a safe and acceptable alternative method of sedation and analgesia during colonoscopy. The safety and efficacy of an oral sedation technique for children having minor oral surgical procedures under local anesthesia were studied. One hundred healthy children between the ages of 2 and 7 yr received either a combination of midazolam (0.35 mg/kg) and ketamine (5 mg/kg) (Group A), or a combination of trimeprazine (3 mg/kg) and methadone (0.2 mg/kg) (Group B) 30 min preoperatively. Hemodynamic parameters, adverse reactions, postoperative recovery, and behavior were evaluated. More children were asleep, but rousable to verbal commands, 30 min after drug administration in Group A (40%) than in Group B (8%). Immediately before the dental procedure, 46% of children in Group A were asleep in contrast to 8% of children in group B. Significantly more children in Group A were awake, coughing, crying, and moving purposefully 30 and 60 min after admission to the recovery room. Two children (4%) in Group A vomited. Ten (20%) children in Group A hallucinated compared to none in Group B. The surgeon rated the procedure as good or very good in 94% of children in Group A compared to 78% in Group B. Our results show that the combination of midazolam and ketamine, administered orally, is a safe, effective, and practical approach to managing children for minor oral surgical procedures under local anesthesia. The purpose of the present study was to test the efficacy of oral-transmucosal route of administration of midazolam in young potentially un-cooperative children. A sample of 40 children up to 4 years of age with ASA I status were randomly divided into experimental and control groups of 20 each. The children in experimental group received 0.5-mg/kg-body weight midazolam mixed in strawberry syrup via the oral-transmucosal route and those in control group were given the same syrup diluted with normal saline. A class II amalgam restoration was performed and routine behavior management techniques were employed in both groups. It was found that the number of procedures successfully completed and sedation produced 15 minutes after test solution administration was significantly greater in the experimental group compared to the control group. The total treatment time was also much lesser in the experimental group children. There was no significant difference in the acceptability of the test solutions in the children of the two groups. 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. A double-blind study was undertaken to determine the efficacy of an oral dose of midazolam 7.5 mg as compared to placebo in a sample of 32 children who had refused dental care after the conventional psychological approach alone was used to reduce fear and apprehensive behavior. Parameters assessed before and 30 minutes after the oral administration of either midazolam or placebo were mental attitude, hypnotic activity, motor activity, quality of sedation and of dental treatment. A three-point scale was designed in each studied parameter and mean values +/- s.e.m. were compared before and after treatment by using Wilcoxon's rank test. It was shown that an oral dose of midazolam 7.5 mg significantly improved all parameters under evaluation (p < 0.01) as compared to placebo, effects which appeared thirty minutes after administration. It is concluded that oral midazolam provides a fast and adequate sedation in children refusing dental care. Thus, the drug is an alternative to other sedative or hypnotic drugs currently used in the premedication of the apprehensive child. This study compared the effect of two different dosages of hydroxyzine supported by 50% nitrous oxide inhalation sedation in child patients.
                Thirty uncooperative healthy children with an age range of 31-120 months were included in this study. Patients were randomly assigned into two groups. The patients in group 1 were given 20 mg of hydroxyzine (Atarax) 24 h preoperatively and on the operation day, 3.7 mg/kg hydroxyzine was administered orally. The patients in group 2 received 3.7 mg/kg hydroxyzine orally only on the operation day. All patients also received 50% nitrous oxide inhalation sedation. The child's behaviour was evaluated every 5 min by using Houpt Sedation Rating Scale. The oxygen saturation and heart rates were also followed.
                The mean age of the children in the study was 61.9 months (SD 11.9) for group 1 and 53.7 months (SD 12.8) for group 2. Evaluation of the results showed that there were no significant differences (P < 0.05) between behavioural attitudes and sedation degree of the patients.
                Twenty milligrams of hydroxyzine administered 24 h preoperatively has no significant benefit on sedation of the child. Dentists usually face a common problem dealing with pediatric patients due to their high levels of anxiety and fear, associated with dental procedures. Such children are usually managed by various pharmacological methods. The efficacy and safety of conscious sedation, using intravenous short acting group of drugs (midazolam, propofol and ketamine) in uncooperative children, requiring oral rehabilitation was thus evaluated in this study. A total of 30 uncooperative children, aged 3-6 years, belonging to ASA I, II category formed the study group. The efficacy of the three group of drugs was evaluated on the basis of the onset of sedation, duration of action, side effects encountered, and the overall cooperative behavior of the child throughout the course of the procedure, after obtaining parental consent. Results showed that propofol was highly effective in terms of onset of sedation, although increased body movements and crying, pain on injection and intermittent cough was observed as the main side effects of the drug. Midazolam showed the longest duration of action, but was not very effective in terms of treatment completion due to increased movements and crying. Maximum cooperation during the procedure was obtained with ketamine and no adverse effects were encountered. We preferred ketamine from the results of our study and recommended future evaluation of ketamine in combination with other sedatives. 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. We studied 411 children aged 3-10 years who were referred for dental treatment. They were randomly allocated to have inhalation conscious sedation with either sevoflurane/nitrous oxide mixture or nitrous oxide alone. Dental treatment was satisfactorily completed in 215/241 children who were given sevoflurane/nitrous oxide mixture (89%) compared with 89/170 who were given nitrous oxide alone (52%) (Chi square 70.3, p < 0.0001). All children remained conscious and responsive to verbal contact throughout the treatment and in the recovery room. No adverse side-effects were recorded in either group and there were no significant differences in oxygen saturation, heart rate, recovery profile, or time to discharge home between the groups. The study concluded that, for every 100 children treated with sevoflurane/nitrous oxide mixture, 37 children would be saved a general anaesthetic if given combined sevoflurane and nitrous oxide mixture rather than nitrous oxide alone. The use of sevoflurane in low concentrations 0.1-0.3% to supplement nitrous oxide and oxygen for inhalation conscious sedation is safe, practical, and significantly more effective than nitrous oxide alone in children having dental treatment. This study was undertaken with a view to determine the acceptance and treatment possibilities of midazolam, depending upon its oral and rectal application for pediatric patients requiring an oral surgery procedure (tooth extraction) and having a pretreatment behavioral score of 1 or 2 according to the Frankl Scale. Oral (0.5 mg/kg) and rectal (0.35 mg/kg) midazolam was compared in view of acceptance of the mode of treatment and local anesthesia, level of amnesia, and adverse effects. Although oral or rectal midazolam application has similar characteristics in respect to ease of working, the oral midazolam application should generally be preferred because it is more easily accepted by pediatric patients. Pre-anesthetic anxiety and emergence agitation are major challenges for anesthesiologists in pediatric anesthesia. Thus, sedative premedication and parental presence during induction of anesthesia (PPIA) are used to treat pre-anesthetic anxiety in children. The aim of the present study was to test if a combination of mother presence and midazolam premedication is effective for improving emergence condition in children undergoing general anesthesia.
                Sixty children were allocated to one of three groups: a sedative group (0.5 mg/kg oral midazolam), a PPIA group or a sedative and PPIA group. When anesthesia was induced with 7% sevoflurane in 100% oxygen, qualities of mask induction were rated. Anesthesia was maintained with sevoflurane (1.5-2.5%) in 60% oxygen and intravenous fentanyl 4 microg/kg. During emergence from anesthesia, the score of the child's emergence behavior was rated.
                The children in the midazolam group showed a better quality of mask induction compared with those in the PPIA group, the addition of parental presence to oral midazolam did not provide additional improvement of mask induction. In contrast, the children in the midazolam + PPIA group were less agitated than those in the other groups at emergence from anesthesia.
                Parental presence during induction of anesthesia enhanced the effect of oral midazolam on emergence behavior of children undergoing general anesthesia. 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.
                Double blind random controlled trial.
                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.
                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.
                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. Midazolam is widely used as a preanesthetic medication for children. Prior studies have used extemporaneous formulations to disguise the bitter taste of IV midazolam and to improve patient acceptance, but with unknown bioavailability. In this prospective, randomized, double-blinded study we examined the efficacy, safety, and taste acceptability of three doses (0.25, 0.5, and 1.0 mg/kg, up to a maximum of 20 mg) of commercially prepared Versed((R)) syrup (midazolam HCl) in children stratified by age (6 mo to <2 yr, 2 to <6 yr, and 6 to <16 yr). All children were ASA class I-III scheduled for elective surgery. Subjects were continuously observed and monitored with pulse oximetry. Ninety-five percent of patients accepted the syrup, and 97% demonstrated satisfactory sedation before induction. There was an apparent relationship between dose and onset of sedation and anxiolysis (P < 0.01). Eight-eight percent had satisfactory anxiety ratings at the time of attempted separation from parents, and 86% had satisfactory anxiety ratings at face mask application. The youngest age group recovered earlier than the two older age groups (P < 0.001). There was no relationship between midazolam dose and duration of postanesthesia care unit stay. Before induction, there were no episodes of desaturation, but there were two episodes of nausea and three episodes of emesis. At the time of induction, during anesthesia, and in the postanesthesia care unit, there were several adverse respiratory events. Oral midazolam syrup is effective for producing sedation and anxiolysis at a dose of 0.25 mg/kg, with minimal effects on respiration and oxygen saturation even when administered at doses as large as 1.0 mg/kg (maximum, 20 mg) as the sole sedating medication to healthy children in a supervised clinical setting.
                Commercially prepared oral midazolam syrup is effective in producing sedation and anxiolysis in doses as small as 0.25 mg/kg; there is a slightly faster onset with increasing the dose to 1.0 mg/kg. At all doses, 97% of patients demonstrated satisfactory sedation, whereas 86% demonstrated satisfactory anxiolysis when the face mask was applied. The aim of this study was to compare the clinical success of three conscious sedation regimens for pediatric dental patients. A clinical trial was performed wherein dental treatment was administered to pediatric patients ASA I and II under conscious sedation.. Fifty-four children were divided into three groups of 18 patients each, randomly assigned Group A received hydroxyzine (2 mg/kg 2 h before treatment and a subsequent dose of 1 mg/kg 20 min before treatment) orally; group B received 0.50 mg/kg midazolam mixed with 1.5 mg/kg hydroxyzine 20 min before treatment orally; group C received chloral hydrate, 50 mg/kg mixed with 1.5 mg/kg hydroxyzine 20 min before treatment orally. The Ohio State Behavioral Rating Scale (OSBRS) showed statistically significant differences between groups B and C with respect to group A. The regimens of midazolam or chloral hydrate mixed with hydroxyzine represent excellent choices for conscious sedation regimens for pediatric dental patients. The present study was undertaken to evaluate Midazolam as a Paediatric conscious sedative agent for a routine Indian dental setup and to compare its efficacy and safety when administered by intranasal and intramuscular routes, at a dosage of 0.2 mg/kg body weight. The present study was accomplished in two phases: Phase 1: Preliminary dose finding pilot study on 10 children. Phase 2: Single dose, randomized parallel clinical trial on 40 children between the ages of 2 and 5 years. These children were randomly assigned to two groups consisting of 20 subjects each. Group M, received Midazolam intramuscularly, while Group N received Midazolam intranasally. Both the intranasal and intramuscular groups showed highly significant decrease in crying levels, motor movements and sensory perception levels, post-sedation (P P < 0.001). Midazolam could be safely and successfully employed by intranasal and intramuscular routes for Paediatric conscious sedation in a routine dental setup with basic facilities at a dosage of 0.2 mg/ kg body weight. Whenever the clinical situation warrants a faster action, peak and recovery, the intranasal route should be the obvious choice. In a prospective, double-blind study, we examined the effects of routine sedation and pharyngeal anesthesia on cardiorespiratory parameters during gastroscopy.
                Intravenous sedation and topical pharyngeal anesthesia are used to alleviate the discomfort during upper gastrointestinal endoscopy. Cardiorespiratory changes during gastroscopy are common.
                Two hundred fifty two consecutive outpatients undergoing gastroscopy were assigned into 4 groups: (1) sedation with intravenous midazolam and placebo throat spray (midazolam group), (2) placebo sedation and pharyngeal anesthesia with lidocaine throat spray (lidocaine group), (3) placebo sedation and placebo throat spray (placebo group), and (4) no intravenous cannula nor throat spray (control group). Arterial oxygen saturation (SaO2), systolic and diastolic blood pressure and continuous electrocardiogram were recorded before, during, and after the endoscopic procedure.
                Gastroscopy increased heart rate in all study groups. Premedication with intravenous midazolam or lidocaine spray alleviated this rise (P<0.001, repeated measures analysis of variance) and decreased the incidence of tachycardia. Similarly, sedation with midazolam or topical pharyngeal anesthesia decreased the rise in systolic blood pressure (P<0.001). Midazolam produced lower SaO2 values during gastroscopy compared with lidocaine, placebo or control groups (P<0.001). However, episodes of desaturation (SaO2 </=92) were no more common in the midazolam group than in other groups.
                Premedication with midazolam alleviated the rise in heart rate and systolic blood pressure but induced a statistically significant decrease in arterial oxygen saturation. However, gastroscopy proved to be a safe procedure both with and without sedation. Thirty children presenting to the dental clinic of a pediatric hospital who required brief but urgent dental care, and who could not be satisfactorily examined or treated, were administered one of three medications--ketamine (Ketalar), 3 mg/kg; midazolam (Versed), 0.4 mg/kg; or sufentanil (Sufenta), 1.5 or 1.0 micrograms/kg--intranasally in a randomized, double-blinded protocol. The patients were brought to the day surgery area following appropriate fasting and administered one of the medications diluted in a dose of 0.1 mL/kg normal saline while sitting in a nurse's arms. Cardiorespiratory monitors were applied when tolerated, and the child was placed on the operating room table. Each child was injected locally with up to one dental cartridge of 2% lidocaine with 1:100,000 epinephrine before dental extractions. A sedation score was recorded using a scale where 1 = hysterical/untreatable, 5 = ideal sedation, and 10 = obtunded and desaturated, requiring airway management assistance. Midazolam administration resulted in acceptable sedation (mean score: 4) with no desaturations below 90% as measured by pulse oximetry and a mean recovery room observation time of only 3 +/- 2 min (+/- SD). Ketamine also had a mean sedation score of 4 and a short recovery period (7 +/- 7 min); however, two children experienced brief desaturations. Sufentanil at 1.5 micrograms/kg was noted to produce much more heavily sedated children (mean score 7), with a high incidence of significant oximetry desaturation (80%) and prolonged recovery room duration (58 +/- 40 min). Use of 1.0 microgram/kg sufentanil resulted in no desaturations, less sedation (mean score 4), and a brief recovery time (7 +/- 13 min).(ABSTRACT TRUNCATED AT 250 WORDS) To evaluate the effect of midazolam alone on sedation in young children for dental restorative care.
                Forty children, aged 5 to 10 years with a mean age of 7.3 years, participated in this study. Twenty-one patients were assigned to intervention group received 0. 5 mg/kg of oral midazolam 20 minutes prior to the beginning of dental treatment, and 19 patients in control group received placebo liquid 20 minutes before treatment All patients received painless local anesthetic injection and were restrained with children's board and bands. Blood pressure (BP), heart rate (HR), oxygen saturation, treatment compliance scores of the Ramsay scale, the Briekopf and Buttner scale, Frankl scale, and the Houpt scale were recorded. Each procedure was taped and all the data were evaluated every 5 minutes by an anesthetist or experienced dentist who was unaware of the drug given to the child.
                HR in intervention group (82.5 +/- 5.1 bpm) was much lower than that in control group (95.2 +/- 8.9 bpm; F = 31.20, P < 0.001). Intervention group had a significantly lower systolic BP level (94.8 +/- 5.6 mm Hg) than control group (98.5 +/- 5.5 mm Hg; F = 4.34, P = 0.04), but the diastolic BP (63.0 +/- 3.5 mm Hg) was not significantly lower than control group (65.5 +/- 4.8 mm Hg; F = 3.31, P = 0.07). Children in intervention group showed more compliance. The patients' scores of the Ramsay scale, Briekopf and Buttner scale, Frankl scale, and Houpt scale in intervention group (1.37 +/- 0.96, 1.37 +/- 0.83, 1.32 +/- 0.67, and 2.32 +/- 1.49, respectively) were significantly lower than those in control group (3.71 +/- 1.23, 2.71 +/- 0.96, 2.71 +/- 0.90, and 4.71 +/- 1.19; F = 44.66, 22.36, 30.39, and 31.88, respectively, all P < 0.001).
                Oral midazolam alone is safe and produces effective sedation for the dental treatment of young children. Oral midazolam application should be generally preferred because it is more easily accepted by pediatric patients. 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. The effect of oral premedication was studied in a double-blind, randomised trial of 200 children undergoing day-stay anaesthesia. Midazolam 0.25 mg/kg, midazolam 0.5 mg/kg, diazepam 0.5 mg/kg or a placebo was given orally one hour prior to anaesthesia. Patient state was assessed at nine stages, from administration of the premedication up to and including induction of anaesthesia, using a four-point behavioural scale. Patient state was also assessed postoperatively in the recovery area and the day-stay ward. There was no difference between the four groups until induction of anaesthesia. At this stage 82% of children were either asleep or awake and calm. Patients who received midazolam 0.5 mg/kg were more likely to be asleep or awake and calm at induction rather than other groups (P = 0.05). Children receiving midazolam 0.5 mg/kg or diazepam 0.5 mg/kg slept longest in the post anaesthetic recovery room (P less than 0.005), and spent most time there (P less than .005). There was no difference between groups in the length of time spent in the day-stay ward or in the number of overnight admissions. The study shows that a high proportion of unsedated children are calm at induction of anaesthesia and that oral midazolam is an effective premedication in children for day-stay anaesthesia. We compared the effects of oral clonidine (4 microg/kg) and midazolam (0.5 mg/kg) on the preanesthetic sedation and postoperative recovery profile in children during tonsillectomy with or without adenoidectomy. In a double-blinded, double-dummy study design, 134 ASA physical status I-II children aged 4-12 yr were randomized to receive a combination of either clonidine and placebo (Group A), or placebo and midazolam (Group B) at 60-90 min and 30 min, respectively, before the induction of anesthesia. Children in the clonidine group exhibited more intense anxiety on separation and during induction of anesthesia via a mask as measured by the modified Yale Preoperative Anxiety Scores. They also had significantly lower mean intraoperative arterial blood pressures, shorter surgery, anesthesia, and emergence times, and a decreased need for supplemental oxygen during recovery compared with the midazolam group. However, the clonidine group had larger postoperative opioid requirements, maximum excitement and pain scores based on the Children's Hospital of Eastern Ontario scale in the Phase 1 postanesthetic care unit. There were no differences between the two groups in the times to discharge readiness, postoperative emesis, unanticipated hospital admission rates, postdischarge maximum pain scores, and 24 h analgesic requirements. The percentage of parents who were completely satisfied with the child's preoperative experience was significantly higher in the midazolam group. There were no differences in parental satisfaction with the recovery period. We conclude that under the conditions of this study, oral midazolam is superior to oral clonidine as a preanesthetic medication in this patient population. Implications: We compared preanesthetic sedation and postoperative recovery after oral clonidine (4 microg/kg) and midazolam (0.5 mg/kg) in children during tonsillectomy. The clonidine group had greater preoperative anxiety and shorter surgery and anesthesia times, but required more postoperative analgesia. Delayed recovery and discharge times did not differ. Midazolam was superior to clonidine as oral preanesthetic medication for these patients. The purpose of this study was to evaluate in a randomized, double-blinded fashion the sedative and behavioral responses of children undergoing pediatric dental procedures as outpatients and who had received a combination of either oral chloral hydrate 50 mg/kg, not to exceed 1 gm, with hydroxyzine 25 mg (Group 1); or oral midazolam 0.5 mg/kg with acetaminophen elixir 10 mg/kg (Group 2). The children were rated according to sleep, movement, crying and overall behavior at preselected intervals that included presedation, introduction to the operating suite, injection, and overall behavior. There were no statistical differences between the two groups in regards to age, weight, length of procedure, or sex. Group 1 was more asleep in the later time intervals (P < 0.05). Their were no statistically significant differences between the groups in relation to the overall evaluation for the procedure. In conclusion, midazolam/acetaminophen is as effective as chloral hydrate/hydroxyzine in the sedation of young children undergoing outpatient dental procedures. Although midazolam is used for sedation of mechanically ventilated newborn babies, this treatment has not been evaluated in a randomised trial. We have done a prospective placebo-controlled study of the effects of midazolam on haemodynamic variables and sedation as judged by a five-item behaviour score. 46 newborn babies on mechanical ventilation for respiratory distress syndrome were randomly assigned to receive midazolam (n = 24) or placebo (n = 22) as a continuous infusion. Doses of midazolam were calculated to obtain plasma concentrations between 200 and 1000 ng/mL within 24 h of starting treatment and to maintain these values throughout the study. Haemodynamic and ventilatory variables were noted every hour, as were complications and possible side-effects of treatment. Mean (SD) duration of inclusion was 78.7 (30.9) h. 1 patient in the treatment group and 7 in the placebo group were withdrawn because of inadequate sedation (p < 0.05). Midazolam gave a significantly better sedative effect than placebo, as estimated by the behaviour score (p < 0.05). Heart rate and blood pressure were reduced by treatment but remained within the normal range for gestational age and there was no effect on ventilatory indices. The incidence of complications was similar in the two groups. No midazolam-related side-effects were noted. Continuous infusion of midazolam at doses adapted to gestational age induces effective sedation in newborn babies on mechanical ventilation, with positive effects on haemodynamic variables. The course of the respiratory distress syndrome was not influenced by this treatment. Midazolam was given over only a few days and the limited effects on heart rate and blood pressure that we report should not encourage long-term administration. Failure of dental treatment caused by anxiety is a common problem in children. Oral midazolam has been the most commonly used premedication for pediatric patient but the use of midazolam may be associated with paradoxical reactions in children. Melatonin may induce a natural sleepiness and improve sedation. We have investigated premedication with melatonin compared with midazolam in children under nitrous oxide/oxygen (N(2)O/O(2)) sedation for dental treatment.
                In a randomized study, 60 children received either 3 mg of melatonin [Melatonina (3 mg(R)) 60 min before the procedure (n = 15); group I], 0.5 mg.kg(-1) melatonin 60 min before the procedure (n = 15; group II), 0.75 mg.kg(-1) midazolam [Dormicum (15 mg/3 ml (R)) 15 min before the procedure (n = 15); group III] or 3 ml of 0.09 NaCl 15 min (n = 7) or 60 min before the procedure (n = 8; group IV) orally. The children were sedated with 40/60% N(2)O/O(2) inhalation. The heart rate and O(2) saturation were monitored during the treatment period. The level of sedation was assessed according to the Ramsay Sedation Scale. The children's sedation success during dental treatment was classified. The sedation success and other sedation-related events recorded. Comparisons among the four groups were made using one-way anova or Kruskal-Wallis test, and if any significant differences were noted, the Tukey's HSD or Mann-Whitney U-test were used for intergroup comparisons. All differences were considered significant at P < 0.05.
                The evaluation of sedation success was as follows: group I: satisfactory (n = 1), average satisfactory (n = 4), and unsatisfactory (n = 10); group II: satisfactory (n = 2), average satisfactory (n = 3), and unsatisfactory (n = 10); group III: satisfactory (n = 9), average satisfactory (n = 6); and group IV: satisfactory (n = 1), average satisfactory (n = 3), and unsatisfactory (n = 11).
                In these doses and clinical conditions, melatonin was similar to that of placebo and did not contribute to N(2)O/O(2) sedation of anxious children. 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.
                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.
                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.
                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. We evaluated the efficacy of clonidine given orally preoperatively for preventing postoperative vomiting (POV) in children undergoing propofol-nitrous oxide anaesthesia for strabismus surgery. Sixty children, ASA physical status I, aged 2-12 years, received diazepam, 0.4 mg x kg(-1) or clonidine, 4 microg x kg(-1) (n=30 each) orally, in a randomized double-blind manner. These drugs were given 105 min before an inhalational induction of anaesthesia. A complete response, defined as no POV and no need for rescue antiemetic medication, during 0-24 h after anaesthesia was 67% with diazepam and 93% with clonidine, respectively (P=0.024). No clinically adverse event was observed in any of the groups. In summary, pretreatment with oral clonidine enhances the antiemetic efficacy of propofol for the prevention of POV after paediatric strabismus surgery. To determine efficacy of midazolam as a sedative in mechanically ventilated newborns.
                Double blind randomized placebo controlled trial.
                Neonatal Unit of Tertiary Hospital.
                Sedation over 48 h of observation.
                Neonates with birth weight less than 2000 g who were mechanically ventilated within 7 days of life were randomly assigned to midazolam and placebo group. Midazolam and placebo were administered as bolus (0.2 mg/kg) followed by continuous infusion (0.06 mg/kg/h). Both groups received morphine infusion (10 microg/kg/h). Sedation score was noted at 6 hourly intervals for 48 hours. Hemodynamic variables, ventilatory variables, complications and side effects of treatments were also recorded.
                Thirty-three neonates were enrolled (17 in midazolam, 16 in placebo group). The groups were comparable for birth weights and gestation. The midazolam group had significantly better sedation from 18-24 hours after enrollment compared to placebo group. At 48 h there were no significant differences in proportion of infants with adequate sedation between midazolam and placebo group. The two groups were comparable with respect to heart rate, perfusion, ventilatory indices and blood gas parameters. None of the infants were noted to have hypotension on loading with midazolam or placebo. Seizures were noted in 2 neonates in placebo group 24 hours after enrollment (insignificant statistically).
                Sedation provided by continuous infusion of midazolam and morphine appears to be comparable to morphine alone in newborn babies on mechanical ventilation, with no significant adverse effects. The course of mechanical ventilation is not influenced by use of midazolam.
There is some weak evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is very weak evidence that nitrous oxide inhalation may also be effective. There is a need for further well designed and well reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.