Midazolam In Children Research Articles

Perioperative dexmedetomidine compared to midazolam in children undergoing open-heart surgery: A pilot randomised controlled trial

ObjectiveThere is a need for evidence on the best sedative agents in children undergoing open heart surgery for congenital heart disease. This study aimed to evaluate the feasibility and safety of dexmedetomidine in this group compared with midazolam. DesignDouble blinded, pilot randomized controlled trial. SettingCardiac operating theatre and paediatric intensive care unit in Brisbane, Australia. ParticipantsInfants (≤12 months of age) undergoing their first surgical repair of a congenital heart defect. InterventionsDexmedetomidine (up to 1.0mcg/kg/hr) versus midazolam (up to 80mcg/kg/hr), commenced in the cardiac operating theatre prior to surgery. Main outcome measuresThe primary outcome was the time spent in light sedation (Sedation Behavior Scale [SBS] -1 to +1); Co-primary feasibility outcome was recruitment, retention and protocol adherence. Secondary outcomes were use of supplemental sedatives, ventilator free days, delirium, vasoactive drug support, and adverse events. Neurodevelopment and health-related quality of life (HRQoL) were assessed at 12 months post-surgery. ResultsSixty-six participants were recruited. The number of SBS scores in the light sedation range were greater in the dexmedetomidine group at 24 hours, 48 hours, and overall study duration (0-14 days) versus the midazolam group (24hr: 76/170 [45%] vs 60/178 [34%], aOR 4.14 [95% CI 0.48, 35.92]; 48hr: 154/298 [52%] vs 122/314 [39%], aOR 6.95 [95% CI 0.77, 63.13]; 0-14 days: 597/831 [72%] vs 527/939 [56%], aOR 3.93 [95% CI 0.62, 25.03]). Feasibility was established with no withdrawals or loss to follow-up at 14 days and minimal protocol deviations. There were no differences between the groups relating to clinical, safety, neurodevelopment or HRQoL outcomes. ConclusionsThe use of dexmedetomidine was associated with more time spent in light sedation when compared with midazolam. The feasibility of conducting a blinded RCT of midazolam and dexmedetomidine in children undergoing open heart surgery was also established. The findings justify further investigation in a larger trial. Clinical trial registrationACTRN12615001304527.

COMPARISON OF ORAL MIDAZOLAM VERSUS ORAL TRICLOFOS FOR SEDATION OF CHILDREN POSTED FOR COMPUTED TOMOGRAPHY SCAN - A RANDOMIZED CONTROLLED, DOUBLE BLIND CLINICAL STUDY

Background: To maintain immobility of children for good quality computed tomography (CT) scans, sedation may be used. Present study was planned to compare the efficacy of oral triclofos and oral midazolam in children undergoing CT. Methodology: The prospective, comparative, randomized Indian study was conducted in Department of Anaesthesia at a J.J. Hospital and Grant Medical college. Study population was paediatric subjects between 2 years and 5 years (both inclusive) with ASA-I, exhibiting fearful or refractory behaviour at previous CT Scans. Oral triclofos 100 mg/kg was given to one group (100 patients) and oral midazolam 0.75 mg/kg in other group (100 patients) in preoperative room with facility of oxygen and multipolar monitor. Standardized scoring systems (Ramsay Sedation Scale, Aldrete Recovery Score) were used for evaluation. Vascular parameters, time of sedation onset and duration of recovery were also assessed. Results: Mean age and gender distribution were comparable between study groups (p>0.05). On comparing heart rate, systolic and diastolic BP between the Midazolam and Triclofos groups at all time-points, no significant difference was found (p>0.05). Mean sedation score and recovery score in the Midazolam group were found to be significantly higher compared to Triclofos group (p<0.05). Mean onset of sedation was found to be significantly quicker in the Midazolam group (p<0.05). In addition, the mean duration of sedation and duration of CT scans were significantly lower in the Midazolam group (p<0.05). Conclusion: Midazolam was found to have a better sedative profile compared to Triclofos in paediatric patients undergoing CT.

Comparative Analysis of Sedative Efficacy of Dexmedetomidine and Midazolam in Pediatric Dental Practice: A Systematic Review and Meta-Analysis.

Children are particularly terrified of having dental treatment. They are physically resistant, frail, and unwilling to cooperate. This severe distress during the pre-operative phase could cause the dentist to have issues with behavior control. Additionally, it may make pediatric dental treatments less effective. In order to reduce anxiety and control behavior in children receiving dental care, sedation is a pharmacological management technique that supports the provision of effective and high-quality dental services. The aim is to compare and evaluate the efficacy of sedative agents like dexmedetomidine and midazolam in pediatric dental practice. A thorough review of the literature was conducted using electronic databases like “MEDLINE, PubMed, and CENTRAL (Cochrane Central Register of Controlled Trials), as well as the World Health Organization International Clinical Trials Registry Platform, www.clinicaltrials.gov, conference proceedings abstracts, a bibliography of pertinent references, and manual searches of journals, conferences, and books”. There were no restrictions on the language or the date of publication when searching the electronic databases.Randomized controlled trials were included which compared dexmedetomidine and midazolam in children up to 16 years of age subjected to dental treatment. Information on procedures, participants, interventions, outcome measures, and results were independently extracted by three review writers (TS, SL, and RO). Trial authors were contacted for papers that were confusing or lacking information. The risk of bias was evaluated for each study. We adhered to the Cochrane statistical recommendations. Three trials totaling 229 participants were included. All three studies were rated as having a low risk of bias, with none of them having a high or unclear risk. Meta-analysis was done for the available data for the primary outcomes like sedation level and recovery time. We searched for randomized controlled trials up to Jan 31, 2020. Participants are randomly assigned to an intervention or control group in randomized controlled trial research. While patients in the control group often get a placebo therapy or procedure, those in the interventional group receive the treatment being studied.We found three studies eligible to include in the review. One study evaluated 73 individuals who received general anesthesia for dental treatment. There were 72 and 84 individuals in the second and third investigations, respectively. All the participants of the three studies were divided randomly into two groups and were subjected to dexmedetomidine and midazolam as sedative agents. We gave the evidence an "extremely low certainty" rating. Because there are just three short trials with unusual parameters for comparison, the results are questionable. Overall, the results do not allow us to draw any firm conclusions. Three randomized controlled trials included in this systematic review reported data with varying conclusions; hence we recommend more randomized controlled trials to be conducted on this subject matter.

Systematic review and meta-analysis comparing the efficacy of dexmedetomidine to midazolam as premedication and a sedative agent in pediatric patients undergoing dental procedures.

Pediatric dental surgeries are associated with the emotions of fear, anxiety, and other behavioral disturbances of children that need to be managed. Sedation using drugs like dexmedetomidine (DEX) and midazolam (MID) is a common pharmacological behavior managing technique. We conducted this meta-analysis to evaluate the efficacy of both these drugs in current literature. A thorough literature search was conducted on PubMed, MEDLINE, Google Scholar, and Cochrane's database for randomized studies that compared sedative efficacy of dexmedetomidine with midazolam in children of 0-15 years of age undergoing dental surgeries. Sedation in children during dental procedure, when used as a premedication, at the time of separation from parents and at the time of mask induction, onset time, duration of anesthesia, and surgery were evaluated. The mean differences (MDs), odds ratio (OR), and their 95% confidence intervals (CIs) were calculated both for continuous and dichotomous outcome data using random-effects model. Seven studies met out inclusion criteria and were analyzed. Results of premedication with DEX was associated with more anxiolysis (OR=0.29, 95% CI: 0.17-0.52, p=0.0001; I2=0%) and at the time of separation from parents (OR=0.36, 95% CI: 0.19-0.69, p=0.002; I2=52%) in comparison to MID. No significant differences in results were seen at mask induction (OR=0.63, 95% CI: 0.34-1.18, p=0.15; I2=47%) and for sedation in children during dental procedures (OR=0.52, 95% CI: 0.07-3.70, p=0.51; I2=72%). Also, there were no significant differences in onset time, duration of anesthesia, and surgery between the two agents. DEX proved to be a better premedicant than MID for pediatric patients. No significant difference in efficacy of both sedative agents was observed in children undergoing dental treatment. More clinical trials need to be conducted to see its efficacy in dental surgeries in children of standardized ages and with standard doses.

Comparing the Sedative Effect of Oral and Intranasal Midazolam and their Effect on Behavior in Pediatric Dental Patients.

AimTo systematically identify and evaluate the available literature based on the sedative effect of oral midazolam compared with midazolam administered intranasally and also compare their effect on behavior of pediatric dental patients.ObjectiveThis systematic review compares the sedative effect and the effect on behavior with oral midazolam and intranasal midazolam.MethodsA search was undertaken through PubMed Central, Cochrane Database of Systematic Reviews, Lilacs, Science Direct and SIGLE. All the studies included the comparison of the sedative effect of oral and intranasal midazolam. Database search identified 178 articles. 165 articles were excluded based on titles and duplication. and complete text of 13 articles were thoroughly evaluated. Four articles were included based on the inclusion criteria to meet the criteria. The selected studies analyzed the children's behavior or anxiety by oral midazolam in comparison to intranasal midazolam administration.ResultsAmong the four studies included in the present review, risk of bias was high in all the articles. The high risk was obtained due to inadequate blinding of personnel and participants in the study, improper allocation concealment and inadequacy in blinding of the outcome assessment. Also, difference observed between oral and intranasal midazolam routes on behavior and sedation level in the studies included in this review was not statistically significant.ConclusionStudies comparing the effect on behavior of oral and intranasal midazolam in children are limited. More number of high-quality clinical trials evaluating the sedative effect and effect on behavior of oral and intranasal midazolam in pediatric dental patients is required.How to cite this articleKotian N, Subramanian EMG, Jeevanandan G. Comparing the Sedative Effect of Oral and Intranasal Midazolam and their Effect on Behavior in Pediatric Dental Patients. Int J Clin Pediatr Dent 2022;15(1):128-134.

COMPARISON OF INTRANASAL DEXMEDETOMIDINE V/S MIDAZOLAM AS A PREMEDICATION IN CHIDREN WITH CONGENITAL HEART DISEASE UNDERGOING CARDIAC SURGERY

Background: The intranasal route is a reliable way to administer preanaesthetics and sedatives to children. The aim of present study was to compare the anxiolytic and sedative effects of intranasal dexemedetomidine and midazolam as a premedication in children with congenital heart disease undergoing cardiac surgery.. Patients and Methods: Fifty chidrens 2-12 years of age group of either sex with congenital heart disease undergoing cardiac surgery were randomly allocated into two groups. Group A-(n=25) - received intranasal dexmedetomidine as premedication.(0.1 µg/kg diluted in 2ml NS ) Group B- (n=25)- received intranasal midazolam as premedication. (0.2 mg/kg diluted in 2ml NS) Heart rate, mean arterial blood pressure and oxygen saturation were monitored upto30 minute after drug administration. The sedation score, anxiety score and child separation score were recorded until the child taken to the OR. The postoperative agitation score was also observed. Results and Conclusion: Premedication with intranasal dexmedetomidine attained significant and satisfactory sedation with better parental separation and lower anxiety levels without any adverse effects as compared with intranasal midazolam in children with congenital heart disease undergoing cardiac surgery.

Sedation With Midazolam After Cardiac Surgery in Children With and Without Down Syndrome: A Pharmacokinetic-Pharmacodynamic Study.

To compare the pharmacokinetics and pharmacodynamics of IV midazolam after cardiac surgery between children with and without Down syndrome. Prospective, single-center observational trial. PICU in a university-affiliated pediatric teaching hospital. Twenty-one children with Down syndrome and 17 without, 3-36 months, scheduled for cardiac surgery with cardiopulmonary bypass. Postoperatively, nurses regularly assessed the children's pain and discomfort with the validated COMFORT-Behavioral scale and Numeric Rating Scale for pain. A loading dose of morphine (100 µg/kg) was administered after coming off bypass; thereafter, morphine infusion was commenced at 40 µg/kg/hr. Midazolam was started if COMFORT-Behavioral scale score of greater than 16 and Numeric Rating Scale score of less than 4 (suggestive of undersedation). Plasma midazolam and metabolite concentrations were measured for population pharmacokinetic- and pharmacodynamic analysis using nonlinear mixed effects modeling (NONMEM) (Version VI; GloboMax LLC, Hanover, MD) software. Twenty-six children (72%) required midazolam postoperatively (15 with Down syndrome and 11 without; p = 1.00). Neither the cumulative midazolam dose (p = 0.61) nor the time elapsed before additional sedation was initiated (p = 0.71), statistically significantly differed between children with and without Down syndrome. Population pharmacokinetic and pharmacodynamics analysis revealed no statistically significant differences between the children with and without Down syndrome. Bodyweight was a significant covariate for the clearance of 1-OH-midazolam to 1-OH-glucuronide (p = 0.003). Pharmacodynamic analysis revealed a marginal effect of the midazolam concentration on the COMFORT-Behavioral score. The majority of children with and without Down syndrome required additional sedation after cardiac surgery. This pharmacokinetic and pharmacodynamic analysis does not provide evidence for different dosing of midazolam in children with Down syndrome after cardiac surgery.

Premedication with Midazolam in Children: A Randomised Control Study between Oral and Intranasal Routes

Premedication with Midazolam in Children: A Randomised Control Study between Oral and Intranasal Routes

Efficacy and Safety of Fentanyl in Combination with Midazolam in Children on Mechanical Ventilation

BackgroundTo evaluate the efficacy and safety of fentanyl for sedation therapy in mechanically ventilated children.MethodsThis was a double-blind, randomized controlled trial of mechanically ventilated patients between 2 months and 18 years of age. Patients were randomly divided into two groups; the control group with midazolam alone, and the combination group with both fentanyl and midazolam. The sedation level was evaluated using the Comfort Behavior Scale (CBS), and the infusion rates were adjusted according to the difference between the measured and the target CBS score.ResultsForty-four patients were recruited and randomly allocated, with 22 patients in both groups. The time ratio of cumulative hours with a difference in CBS score (measured CBS–target CBS) of ≥ 4 points (i.e., under-sedation) was lower in the combination group (median, 0.06; interquartile range [IQR], 0–0.2) than in the control group (median, 0.15; IQR, 0.04–0.29) (P < 0.001). The time ratio of cumulative hours with a difference in CBS score of ≥ 8 points (serious under-sedation) was also lower in the combination group (P < 0.001). The cumulative amount of midazolam used in the control group (0.11 mg/kg/hr; 0.07–0.14 mg/kg/hr) was greater than in the combination group (0.07 mg/kg/hr; 0.06–0.11 mg/kg/hr) (P < 0.001). Two cases of hypotension in each group were detected but coma and ileus, the major known adverse reactions to fentanyl, did not occur.ConclusionFentanyl combined with midazolam is safe and more effective than midazolam alone for sedation therapy in mechanically ventilated children.Trial RegistrationClinicalTrials.gov Identifier: NCT02172014

Characterization of Intestinal and Hepatic CYP3A-Mediated Metabolism of Midazolam in Children Using a Physiological Population Pharmacokinetic Modelling Approach

PurposeChanges in drug absorption and first-pass metabolism have been reported throughout the pediatric age range. Our aim is to characterize both intestinal and hepatic CYP3A-mediated metabolism of midazolam in children in order to predict first-pass and systemic metabolism of CYP3A substrates.MethodsPharmacokinetic (PK) data of midazolam and 1-OH-midazolam from 264 post-operative children 1–18 years of age after oral administration were analyzed using a physiological population PK modelling approach. In the model, consisting of physiological compartments representing the gastro-intestinal tract and liver,intrinsic intestinal and hepatic clearances were estimated to derive values for bioavailability and plasma clearance.ResultsThe whole-organ intrinsic clearance in the gut wall and liver were found to increase with body weight, with a 105 (95% confidence interval (CI): 5–405) times lower intrinsic gut wall clearance than the intrinsic hepatic clearance (i.e. 5.08 L/h (relative standard error (RSE) 10%) versus 527 L/h (RSE 7%) for a 16 kg individual, respectively). When expressed per gram of organ, intrinsic clearance increases with increasing body weight in the gut wall, but decreases in the liver, indicating that CYP3A-mediated intrinsic clearance and local bioavailability in the gut wall and liver do not change with age in parallel. The resulting total bioavailability was found to be age-independent with a median of 20.8% in children (95%CI: 3.8–50.0%).ConclusionIn conclusion, the intrinsic CYP3A-mediated gut wall clearance is substantially lower than the intrinsic hepatic CYP3A-mediated clearance in children from 1 to 18 years of age, and contributes less to the overall first-pass metabolism compared to adults.

Comparison of sedation scores after nebulized and intravenous Midazolam in children

Background: An efficacious, reliable, and non-invasive route of administration for midazolam, a drug used for sedation and pre-anesthetic medication, would have obvious advantages. This study compares the sedation achieved by nebulized route and intravenous route as procedural sedation.Methods: A randomized double-blinded interventional study was designed to compare the effect of nebulized midazolam with intravenous midazolam as a sedative medication in 86 children undergoing imaging procedures like CT scan, MRI scan, EEG. Ramsay sedation scores and parameters of cardiovascular and respiratory function were measured over 20 min and summarized Results: The mean sedation score in both groups was comparable at baseline, 10 minutes and 20 minutes with p values of 0.1, 0.1, 0.09 respectively. Parameters of cardiovascular and respiratory function were comparable in both the groups. Conclusion: Present study showed that nebulized midazolam when given at a higher dose of 1 mg/kg was found to be as potent as intravenous midazolam, opening up a door for a sedative which is easier to administer, has better acceptance with lesser complication.

Evaluating Clinical Effectiveness and Pharmacokinetic Profile of Atomized Intranasal Midazolam in Children Undergoing Laceration Repair

BackgroundAtomized intranasal midazolam is a common adjunct in pediatrics for procedural anxiolysis. There are no previous studies of validated anxiety scores with pharmacokinetic data to support optimal procedure timing. ObjectivesWe describe the clinical and pharmacokinetic profile of atomized intranasal midazolam in children presenting for laceration repair. MethodsChildren 11 months to 7 years of age and weighing <26 kg received 0.4 mg/kg of atomized intranasal midazolam for simple laceration repair. Blood samples were obtained at 3 time points in each patient, and the data were fit with a 1-compartment model. Patient anxiety was rated with the Observational Scale of Behavioral Distress. Secondary outcomes included use of adjunctive medications, successful completion of procedure, and adverse events. ResultsSixty-two subjects were enrolled, with a mean age of 3.3 years. The median time to peak midazolam concentration was 10.1 min (interquartile range 9.7–10.8 min), and the median time to the procedure was 26 min (interquartile range 21–34 min). There was a trend in higher Observational Scale of Behavioral Distress scores during the procedure. We observed a total of 2 adverse events, 1 episode of vomiting (1.6%) and 1 paradoxical reaction (1.6%). Procedural completion was successful in 97% of patients. ConclusionsAtomized intranasal midazolam is a safe and effective anxiolytic to facilitate laceration repair. The plasma concentration was >90% of the maximum from 5 to 17 min, suggesting this as an ideal procedural timeframe after intranasal midazolam administration.

Effects of dexmedetomidine versus midazolam for premedication in paediatric anaesthesia with sevoflurane: A meta-analysis.

BackgroundDexmedetomidine (DEX), an α2-adrenergic receptor agonist, produces ideal sedation and early postoperative recovery for premedication in paediatric surgery, reducing preoperative anxiety and facilitating smooth induction of anaesthesia. We performed a meta-analysis to compare the effects of DEX and midazolam (MDZ) in paediatric anaesthesia with sevoflurane.MethodsPubMed, Ovid, Web of Science, and Public Health Management Corporation were searched through December 2016 for randomized controlled trials (RCTs) that compared DEX and MDZ in children undergoing sevoflurane anaesthesia. The risk ratio (RR) with 95% incidence interval (95%CI) was used for dichotomous variables.ResultsTwelve RCTs involving 422 patients in the DEX group and 448 patients in the MDZ group were included. Patients in the DEX group had a significantly lower incidence of unsatisfactory sedation (RR [95%CI] = 0.71 [0.57–0.89]), unsatisfactory parental separation (RR [95%CI] = 0.56 [0.35–0.87]), and rescue analgesia (RR [95%CI] = 0.52 [0.35–0.77]) than patients in the MDZ group. However, both groups had a similar incidence of unsatisfactory mask acceptance, emergence agitation, and postoperative nausea and vomiting.ConclusionCompared with MDZ, DEX is beneficial in paediatric anaesthesia with sevoflurane because of its lower incidence of unsatisfactory sedation, parental separation, and rescue analgesia.

Pre Medication With Midazolam in Children For Smooth Separation From Parents: A Comparison Of Two Different Routes of Administration

Premedication with midazolam is widely used in paediatric anaesthesia to reduce fear, anxiety, emotion, psychological trauma and ensure smooth separation from parents. However, various routes and dosing regimens are recommended for paediatric premedication and variable efficacy is found when use in different routes. The aim of our study to compare the efficacy and acceptable route between intranasal versus sublingual midazolam premedication for smooth separation from parents before entering the operation theater. It will be a comparative, cross-sectional prospective clinical study. 120 unmedicated children, ASA I or II, Age 1–6 years, who will be scheduled for routine elective surgery and who will be planned to receive midazolam as a premedicant drug, will be randomly assigned to one of the two groups. Group–I receives intranasal midazolam 0.2 mg kg-1 and Group–II receives sublingual midazolam 0.2 mg kg-1 after having obtained the parent’s informed consent. Heart rate, Systolic blood pressure, SpO2, Sedation and Anxiolysis Scores will be assessed in 4-point scale by the anaesthesiologist every 3 min prior to surgery. Sixty patients will be enrolled in each group, I and II. Data will be compiled and analyzed in computer, using statistical software package SPSS.&#x0D; JCMCTA 2016 ; 27 (2) : 24 - 30

Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial

The optimal intranasal volume of administration for achieving timely and effective sedation in children is unclear. We aimed to compare clinical outcomes relevant to procedural sedation associated with using escalating volumes of administration to administer intranasal midazolam. We conducted a randomized, single-blinded, 3-arm, superiority clinical trial. Children aged 1 to 7 years and undergoing laceration repair requiring 0.5 mg/kg intranasal midazolam (5 mg/mL) were block-randomized to receive midazolam using 1 of 3 volumes of administration: 0.2, 0.5, or 1 mL. Procedures were videotaped, with outcome assessors blinded to volume of administration. Primary outcome was time to onset of minimal sedation (ie, score of 1 on the University of Michigan Sedation Scale). Secondary outcomes included procedural distress, time to procedure start, deepest level of sedation achieved, adverse events, and clinician and caregiver satisfaction. Ninety-nine children were enrolled; 96 were analyzed for the primary outcome and secondary outcomes, except for the outcome of procedural distress, for which only 90 were analyzed. Time to onset of minimal sedation for each escalating volume of administration was 4.7 minutes (95% confidence interval [CI] 3.8 to 5.4 minutes), 4.3 minutes (95% CI 3.9 to 4.9 minutes), and 5.2 minutes (95% CI 4.6 to 7.0 minutes), respectively. There were no differences in secondary outcomes except for clinician satisfaction with ease of administration: fewer clinicians were satisfied when using a volume of administration of 0.2 mL. There was a slightly shorter time to onset of minimal sedation when a volume of administration of 0.5 mL was used compared with 1 mL, but all 3 volumes of administration produced comparable clinical outcomes. Fewer clinicians were satisfied with ease of administration with a volume of administration of 0.2 mL.

Oral midazolam versus oral triclofos for sedation of children for computed tomography scan - a randomized clinical trial

Background: Effective and safe pediatric procedural sedation is still a concern especially in areas outside operation theatres. The aim of the study was to compare the efficacy and safety of oral triclofos and oral midazolam in children undergoing computed tomography.Methods: A prospective randomized double blind study was conducted in 100 children aged one to five years. Group-I (n=50) received oral triclofos 100 mg/kg and Group-II (n=50) oral midazolam 0.75 mg/kg. Both groups were given oral atropine 0.03 mg/kg and supplemented with intravenous midazolam upto 0.1 mg/kg in case of inadequate effect. Onset and duration of sedation, success for completion of procedure and time to recovery were noted. Student’s t test and Z test of proportions were used for statistical analysis.Results Majority of children 36(72%) in Group-I achieved Ramsay Sedation Score &gt;4 as compared to 25(50%) in Group-II. Computed tomography scan could be successfully completed at comparable rate (52% vs 56%). Success rate improved to 96% vs 80% after supplementing intravenous midazolam in Group I &amp; II respectively (p&lt; 0.05). Onset (37.91minutes ± 7.96 vs 26 ± 10), duration of sedation ( 117.91minutes ± 72.41 vs 66.2minutes ± 33) were significantly shorter and recovery (98.19minutes ± 72.58 vs 47.4minutes ± 31.42) in Group I &amp; II respectively was faster in children who received oral midazolam (p&lt; 0.05).Conclusion We conclude that both drugs were equally effective and safe for computed tomography scan in children. However better recovery profile of midazolam makes it more suitable for day care procedures.Journal of Society of Anesthesiologists of Nepal 2015; 2(2): 41-45

An evaluation of the effectiveness and safety of midazolam in children undergoing dental surgery

ObjectiveThe aim of this study was to evaluate the effectiveness and safety of oral midazolam in children undergoing dental surgery. Materials and methodsA prospective, randomized, controlled trial was conducted to assess the effectiveness and safety of midazolam in children. Patients aged 2–9 years who underwent dental surgery under general anesthesia were randomly allocated into one of the four groups: midazolam 0.2mg/kg dose group (n=30); midazolam 0.21–0.4mg/kg dose group (n=15); midazolam more than 0.41mg/kg dose group (n=15) or the placebo group (n=31). The effectiveness of midazolam on sedation was assessed by the evaluation of vital signs, such as the respiratory and heart rate, oxygen saturation and the patients’ reactive behaviors, in comparison with the placebo. ResultsThe scores of the ratings for sleep, movement and crying, as well as patients’ reactions at the moment of separation from their parents and their collaboration with the staff were statistically significantly better among patients who received oral midazolam compared with the placebo. There were statistically significant direct correlations between the doses of midazolam and higher sleep, movement, crying and reaction scores 30min after premedication as well as higher scores of patients upon separation from their parents. There were only a few clinically insignificant side effects. ConclusionsOral midazolam, at a single dose from 0.2 to 0.6mg/kg, is effective and safe, and provides the expected sedative effects in children required by premedication for dental surgery.

Inter-individual variation in midazolam clearance in children

ObjectivesTo determine the extent of inter-individual variation in clearance of midazolam in children and establish which factors are responsible for this variation.MethodsA systematic literature review was performed to identify papers...

The Use of Midazolam in Paediatric Dentistry: A Review of the Literature

Context: Behaviour management and carrying out dental procedures for very young pre-cooperative, highly anxious or medically disabled children could be a challenging task. Various drugs and methods have been introduced to render treatment for this group of child patients. Midazolam is a benzodiazepine used as an adjunct to behaviour management techniques in the dental treatment of child patients. Evidence Acquisition: To conduct this review of the literature, Pub-Med and Scopus were searched using the following terms: midazolam, oral, transmucosal, intravenous, intramuscular, rectal, premedication, paediatric dentistry, general anaesthesia. Fourty-five published papers relating to the use of midazolam in paediatric dentistry were shortlisted out of an initial 124 publications and assessed according to the “critical appraisal skills programme” criteria. Randomized controlled trials, non- randomized studies, clinical trials and case reports were reviewed with regard to midazolam's indications, contraindications, drug interactions and various administration routes when used as a single sedative agents. Research and reviews based on the single-drug use of midazolam in children with adequate sample size as well as clinical guidelines were included. However, those conducted on adult populations, using poly-pharmacy for sedation and clinical investigations with flaws or non-significant results were excluded. Conclusions: Midazolam could be used as a safe and effective drug for conscious sedation, general anaesthetic premedication and the treatment of seizures during dental treatment. However, further research on paediatric patients would be beneficial.

Reported side effects of intravenous midazolam sedation when used in paediatric dentistry: a review.

Intravenous (IV) midazolam may be of value as an alternative paediatric dental sedation technique, but there is some apprehension concerning its routine use due to a lack of evidence regarding its safety and side effects. To review all available literature reporting the side effects of IV midazolam in children undergoing dental procedures. Both randomised controlled trials (RCT) and non-randomised studies were reviewed. Reported side effects were categorised as either significant or minor, and the percentage prevalence of significant or minor side effects per episode of treatment was calculated. Five RCTs were included, in which no significant side events were reported; however, minor side effects were recorded (n = 33, 19.5%), with paradoxical reaction being the most common (n = 11, 6.5%). Six non-randomised studies were included, in which no significant side effects were reported; however, minor side effects were reported (n = 118, 16.8%) with paradoxical reaction being the most common (n = 89, 12.7%). Although no significant side effects were recorded, of the minor side effects reported paradoxical reaction was the most common. Due to inconsistency in side effect reporting, the authors suggest the application of a standardised adverse event reporting tool for future studies of sedation in paediatric dentistry.