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.
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.
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.