Background: Midazolam is a water soluble benzodiazepine which is frequently administered by intravenous and oral routes in our institution. Its nasal spray has become recently available.Objectives: To compare the efficacy of midazolam administered orally and by intranasal spray, with the specific objective of assessing their efficacy in terms of acceptability to the patients, whether they achieve a satisfactory sedation score, and the overall ease of inducing general anesthesia. Patients and Methods: Sixty healthy children of ASA grade I or II, aged 2-6 years who were undergoing elective surgery of approximately 30 minutes duration, were assigned to receive midazolam premedication in a randomized controlled trial. They were divided into 2 groups of 30 patients each. Group I: 30 patients received midazolam orally (parenteral solution mixed in honey). Group II: 30 patients received a commercially available midazolam nasal spray.Results: The study shows that children better accepted the drug when administered orally than when administered intranasally, although satisfactory sedation scores at 10 and 20 minutes were better in the nasal spray group than in the oral group [i.e., 6 (20%) vs. 0 (0%) at 10 min and 16 (53.3%) vs.13 (43.3%), respectively]. Satisfactory ease of induction scores [24 (80%) vs. 13 (43.3%)], recovery times [11.63±4.19 minutes vs. 25.20±9.36 minutes], and post-anesthesia recovery scores were better in the nasal spray group (group II) than in the oral group (group I).Conclusions: On the basis of our study, we conclude that nasal midazolam spray is acceptable and is a good alternative to oral midazolam as premedication in the pediatric population.

Background. The aim of this investigation was to compare the sedative effects of oral midazolam/chloral hydrate and mid-azolam/promethazine combinations on fearful children needing dental treatment. Methods. This crossover double-blind clinical trial was conducted on 30 children aged 2‒ 6 years, who had at least two similar teeth needing pulp treatment. Standard vital signs were recorded before and after premedication. Wilson sedation scale was used to judge the level of sedation. Cases were divided into two groups based on the sequence of medication received. This was to overcome the sequence effect. Group I received oral midazolam (0. 4 mg/kg/chloral hydrate (50 mg/kg) at the first visit while they received midazolam (0. 4 mg/kg)/promethazine (5 mg/kg) in their second visit. Group II received the premed-ication in the opposite sequence. The operator and child were blinded to the medication administered. Sedative efficacy of the two combinations were assessed and judged by two independent pediatric dentists based on the Wilson scale. Data were analyzed with ANOVA and paired t-test. Results. Only 10% of children who received chloral hydrate with midazolam exhibited high improvement in their behavior while 53% showed reasonable positive changes and 12% had no change or even deterioration of behavior. The difference between the effect of the two combination drugs was statistically significant (P<0. 05) in favor of the chloral hydrate group. Conclusion. The results showed a significant difference in the sedation level induced between the two groups. Midazo-lam/chloral hydrate combination more effectively improved the co-operation for dental treatment.

Background- Although midazolam and ketamine are widely administrated as oral premedications for children, only a few studies have investigated the cardiovascular, respiratory and sedative effects of these drugs in children with congenital heart disease (CHD).Methods- We compared three methods of administering midazolam and ketamine and a combination of these two drugs as an oral premedication in 165 children with CHD, ASA class II-III, aged 2-8 years, and candidates for cardiac surgery. In this prospective, randomized double-blinded study, we examined hemodynamics, respiratory rate, hemoglobin oxygen saturation, degree of sedation, adverse events such as nausea, vomiting, hallucinations and finally face-mask acceptance or IV line insertion reaction at induction time in three groups. Patients received midazolam 0.5 mg/kg, ketamine 6 mg/kg, or midazolam 0.25 mg/kg plus ketamine 3 mg/kg, 45 minutes before the induction of anesthesia.Results- Heart rate, respiratory rate and hemoglobin oxygen saturation were stable in all three groups. However, systolic and diastolic blood pressure were significantly higher in the ketamine group than those in the other two groups (p=0.001). Sedation score was gradually increased in all the groups, with maximum rate after 45 minutes. After 30 minutes, the midazolam+ketamine group had significantly higher sedation than the other groups (p=0.04). All patients in the three groups had satisfactory separation from their parents. At the time of induction, the cooperation score for face mask acceptance was 81 to 84% among the groups, with no significant differences. However, cooperation at IV line insertion time in the ketamine and the midazolam+ketamine groups (23%, 24%) was better than that in the midazolam group (12%, p=0.03).There were six episodes of emesis in the ketamine group and one episode of nausea in the midazolam+ketamine group.Conclusion- Midazolam and ketamine alone or as a mixed combination are safe oral premedicants in children with CHD undergoing cardiac surgery.

Introduction: Both midazolam and promethazine are recommended to be used as sedatives in many studies but each have some side effects that limits their use. Combination therapy as an alternative method, may decreases these limitations. Therefore, this study aimed to compare midazolam with midazolam-promethazine regarding induction, maintenance, and recovery characteristics following pediatric procedural sedation and analgesia.Methods: Children under 7 years old who needed sedation for being CT scanned were included in this double-blind randomized clinical trial. The patients were randomly divided into 2 groups: one only received midazolam (0.5 mg/kg), while the other group received a combination of midazolam (0.5 mg/kg) and promethazine (1.25 mg/kg). University of Michigan Sedation Scale (UMSS) was used to assess sedation induction. In addition to demographic data, the child’s vital signs were evaluated before prescribing the drugs and after inducing sedation (reaching UMSS level 2). The primary outcomes in the present study were onset of action after administration and duration of the drugs’ effect.Results: 107 patients were included in the study. Mean onset of action was 55.4±20.3 minutes for midazolam and 32.5±11.1 minutes for midazolam-promethazine combination (p<0.001). But duration of effect was not different between the 2 groups (p=0.36). 8 (7.5%) patients were unresponsive to the medication, all 8 of which were in the midazolam treated group (p=0.006). Also in 18 (16.8%) cases a rescue dose was prescribed, 14 (25.9%) were in the midazolam group and 4 (7.5%) were in the midazolam-promethazine group (p=0.02). Comparing systolic (p=0.20) and diastolic (p=0.34) blood pressure, heart rate (p=0.16), respiratory rate (p=0.17) and arterial oxygen saturation level (p=0.91) showed no significant difference between the 2 groups after intervention. Conclusion: Based on the findings of this study, it seems that using a combination of midazolam and promethazine not only speeds up the sedation induction, but also decreases unresponsiveness to the treatment and the need for a rescue dose.

Introduction: Motion artifacts are a common problem in pediatric radiographic studies and are a common indication for pediatric procedural sedation. This study aimed to compare the combination of oral midazolam and ketamine (OMK) with oral midazolam alone (OM) as procedural sedatives among children undergoing computed tomography (CT) imaging. Methods: The study population was comprised of six-month to six-year old patients with medium-risk minor head trauma, who were scheduled to undergo brain CT imaging. Patients were randomly allocated to two groups: one group received 0.5 mg/kg midazolam (OM group, n = 33) orally and the other one received 0.2 mg/kg midazolam and 5 mg/kg ketamine orally (OMK group, n=33). The vital signs were monitored and recorded at regular intervals. The primary outcome measure was the success rate of each drug in achieving adequate sedation. Secondary outcome measures were the time to achieve adequate sedation, time to discharge from radiology department, and the incidence of adverse events. Results: Adequate sedation was achieved in five patients (15.2%) in OM group and 15 patients (45.5%) in OMK group, which showed a statistically significant difference between the groups (p = 0.015). No significant difference was noted between OM and OMK groups with respect to the time of achieving adequate sedation (33.80 ± 7.56 and 32.87 ± 10.18 minutes, respectively, p = 0.854) and the time of discharging from radiology department (89.60 ± 30.22 and 105.27 ± 21.98 minutes, respectively, p=0.223). The complications were minor and similar among patients of both groups. Conclusion: This study demonstrated that in comparison with OM, OMK was more effective in producing a satisfactory level of sedation in children undergoing CT examinations without additional complications, however, none of these two regimens fulfilled clinical needs for procedural sedation.