Intranasal Administration Of Midazolam Research Articles

Efficacy and Tolerability of Intranasal Midazolam Administration for Antiseizure Treatment in Adults: A Systematic Review.

The objective of this study was to assess the efficacy and tolerability of intranasal midazolam (in-MDZ) administration for antiseizure treatment in adults. Embase and Medline literature databases were searched. We included randomized trials and cohort studies (excluding case series) of adult patients (≥18 years of age) examining in-MDZ administration for epilepsy, epileptic seizures, or status epilepticus published in English between 1985 and 2022. Studies were screened for eligibility based on predefined criteria. The primary outcome was the efficacy of in-MDZ administration, and the secondary outcome was its tolerability. Extracted data included study design, patient characteristics, intervention details, and outcomes. Risk of bias was assessed using the Cochrane Risk of Bias Tool. A total of 12 studies with 929 individuals treated with in-MDZ were included. Most studies were retrospective, with their number increasing over time. Administered in-MDZ doses ranged from 2.5 to 20mg per single dose. The mean proportion of successful seizure termination after first in-MDZ administration was 72.7% (standard deviation [SD] 18%), and the proportion of seizure recurrence or persistent seizures ranged from 61 to 75%. Most frequent adverse reactions to in-MDZ were dizziness (mean 23.5% [SD 38.6%]), confusion (one study; 17.4%), local irritation (mean 16.6% [SD 9.6%]), and sedation (mean 12.7% [SD 9.7%]). Administration of in-MDZ seems promising for the treatment of prolonged epileptic seizures and seizure clusters in adults. Limited evidence suggests that intranasal administration is safe. Further research is warranted because of the heterogeneity of cohorts, the variation in dosages, and the lack of uniformity in defining successful seizure termination.

An Unusual Case of Delayed Midazolam Anaphylaxis and a Review of the Current Literature.

Midazolam is a commonly used, well-tolerated, anxiolytic, sedative, anesthesia induction agent, and an adjunct for procedural sedation that is used widely in the emergency department. The ability to administer midazolam via multiple routes, including intranasal, makes it a particularly common choice for use in children. Intranasal administration is safe, easy, and well tolerated and has been shown to be an effective method of obtaining anxiolysis and/or sedation. Adverse drug reactions, including allergic reactions, can occur with any medication. However, anaphylaxis is an uncommon phenomenon from midazolam. Despite being one of the most common medications used in the emergency department and operating room, there are only a handful of unequivocal cases of anaphylaxis secondary to midazolam. The rarity of this presentation may lead to delays in care and potential adverse outcomes as a result. We present one such case of a 10-year-old patient who experienced anaphylaxis after administration of intranasal midazolam to facilitate a computed tomography scan.

Out-of-hospital rescue medication in dogs with emergency seizure disorders: an owner perspective.

Emergency seizure disorders such as status epilepticus and cluster seizures are unlikely to cease spontaneously while prolonged seizure activity become progressively more resistant to treatment. Early administration of rescue medication in canine epileptic patients, in particular benzodiazepines, at seizure onset by the owners can be life-saving and brain protecting. Clinical studies in dogs evaluating the use of rescue medication in hospital environment exist, however, the owner perspective has not been assessed to date. To evaluate the use of rescue medication in dogs with seizure emergencies by the owner at home. Observational study based on online surveys of owners of dogs with emergency seizure disorders. The questionnaire was answered by 1,563 dog owners, of which 761 provided complete and accurate answers suitable for analysis. Of these, 71% administered diazepam, 19% midazolam, 6% levetiracetam, 3% lorazepam, and 4% more than one rescue or other medication. Overall, the success rates based on owners' perspective for intranasal midazolam and rectal diazepam were 97 and 63%, respectively. Owners reported a compliance level of 95 and 66% for intranasal midazolam and rectal diazepam administration, respectively. Even though rectal diazepam was the most used rescue medication in this survey population, intranasal midazolam was perceived by the owners as a better option regarding effectiveness, time to seizure cessation and owner compliance.

Development of a pharmacokinetic and pharmacodynamic model for intranasal administration of midazolam in older adults: a single-site two-period crossover study

BackgroundIntranasal midazolam can produce procedural sedation in frail older patients with dementia who are unable to tolerate necessary medical or dental procedures during domiciliary medical care. Little is known about the pharmacokinetics and pharmacodynamics of intranasal midazolam in older (>65 yr old) people. The aim of this study was to understand the pharmacokinetic/pharmacodynamic properties of intranasal midazolam in older people with the primary goal of developing a pharmacokinetic/pharmacodynamic model to facilitate safer domiciliary sedation care. MethodsWe recruited 12 volunteers: ASA physical status 1–2, aged 65–80 yr, and received midazolam 5 mg intravenously and 5 mg intranasally on two study days separated by a 6 day washout period. Concentrations of venous midazolam and 1ʹ–OH–midazolam, Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score, bispectral index (BIS), arterial pressure, ECG, and respiratory parameters were measured for 10 h. ResultsTime to peak effect of intranasal midazolam for BIS, MAP, and SpO2 were 31.9 (6.2), 41.0 (7.6), and 23.1 (3.0) min, respectively. Intranasal bioavailability was lower compared with intravenous administration (Fabs 95%; 95% confidence interval: 89–100%). A three-compartment model best described midazolam pharmacokinetics following intranasal administration. A separate effect compartment linked to the dose compartment best described an observed time-varying drug-effect difference between intranasal and intravenous midazolam, suggesting direct nose-to-brain transport. ConclusionsIntranasal bioavailability was high and sedation onset was rapid, with maximum sedative effects after 32 min. We developed a pharmacokinetic/pharmacodynamic model for intranasal midazolam for older persons and an online tool to simulate changes in MOAA/S, BIS, MAP, and SpO2 after single and additional intranasal boluses. Clinical trial registrationEudraCT (2019-004806-90).

PHARMACOKINETICS AND PHARMACODYNAMICS OF PROPOFOL AND DEXMEDETOMIDINE DURING ELECTIVE PROCEDURAL SEDATIONS AND CHARACTERISTICS OF THEIR COMBINATION (LITERATURE REVIEW)

In the previous publication, we outlined the general principles of procedural sedation (PS), the depth of suppression of consciousness and spontaneous motor activity, the minimum quantity of patients' pre-procedural examinations and the aspects of informed consent obtaining. The principles of vital signs monitoring, patients' immobilisation, and the detection and treatment of adverse events have been described. A key aspect of the PS is the readiness to ensure patency of the airways and oxygenation at least one level deeper than the existing level of the PS.
 In this publication, attention is focused on the pharmacokinetics and pharmacodynamics of propofol and dexmedetomidine - the main drugs for elective PS and on the combination between them. In a future publication, we plan to characterize other key medications for PS, such as midazolam, ketamine, thiopental, and fentanyl.
 Propofol is a short-track anaesthesia drug, and it was the most widely distributed in the 21st century because after its use patients quickly and fully regain consciousness. At the same time, to achieve the necessary deep level of sedation and prevent unintended movements of the patient, it is often required to use high doses of propofol that can cause clinically significant suppression of the patency of the upper respiratory airways, depth of breathing, and hemodynamic. Therefore, in this publication, we promote the implementation of multimodal sedation and analgesia with the use of moderate doses of several drugs, which allows a significant reduction in the dose of propofol and thus increase the safety of PS. Dexmedetomidine has both sedative and analgesic properties with a minimal effect on the patency of the upper airways and the depth of breathing, thus is the best drug to combine with propofol in PS.
 In children, intranasal administration of dexmedetomidine and midazolam is an important alternative method of premedication, which provides a gentle entry into sedation and prevents the child's stress reactions to the placement of a venous catheter. Although the use of dexmedetomidine in children's practice is still "off-label" and outside the indications approved by the FDA in this publication we provide evidence to justify its safety and effectiveness of its usage in paediatrics PS.

Efficacy and safety of intranasal midazolam versus intranasal ketamine as sedative premedication in pediatric patients: a meta-analysis of randomized controlled trials

BackgroundIntranasal midazolam and ketamine have been widely used as sedative premedication in children. It is difficult to determine which one yields better sedative effects for clinical practice. We conducted the present meta-analysis by summarizing the evidences to evaluate the efficacy and safety of intranasal midazolam versus intranasal ketamine as sedative premedication in pediatric patients.MethodsWe searched PubMed, Embase, and Cochrane Library from inception to April 2022. All randomized controlled trials (RCTs) used intranasal midazolam and ketamine as sedatives in children were enrolled. The risk of bias in RCTs was assessed by Cochrane risk of bias tool. Condition of parental separation, anesthesia induction or facemask acceptance, sedation level, different hemodynamic parameters and adverse events were considered as the outcomes in our study.ResultsA total of 16 studies with 1066 patients were enrolled. Compared with midazolam, administration of intranasal ketamine might be associated with severer changes in hemodynamics parameters including mean blood pressure (SMD = -0.53, with 95% CI [-0.93, -0.13]) and heart rate (HR) (SMD = -1.39, with 95% CI [-2.84, 0.06]). Meanwhile, administration of intranasal midazolam was associated with more satisfactory sedation level (61.76% vs 40.74%, RR = 1.53, with 95%CI [1.28, 1.83]), more rapid onset of sedation (SMD = -0.59, with 95%CI [-0.90, -0.28]) and more rapid recovery (SMD = -1.06, with 95%CI [-1.83, -0.28]). Current evidences also indicated that the differences of various adverse effects between two groups were not significant.ConclusionsGiven that administration of midazolam via intranasal route provides more satisfactory sedative level with less fluctuation of hemodynamics parameters and more rapid onset and recovery, it might be considered as the preferred sedative premedication for pediatric patients compared to ketamine. However, the widespread evidences with low or moderate quality indicated that superiority of intranasal midazolam in pediatric sedation needs to be confirmed by more studies with high quality and large sample size in future.Trial registrationThe protocol of present study was registered with PROSPERO (CRD42022321348).

Intranasal Midazolam Premedication for Digital Image-Assisted Fundus Examination in Preterm Neonates.

We aimed to evaluate the feasibility and tolerability of fundus examination in preterm newborns after implementing a premedication with intranasal midazolam as a quality improvement project in a neonatal intensive care unit (NICU). Prospective examination of all fundus examinations between January and June 2022, before 0 (T0) and after 1 (T1), 15 (T15), and 60 (T60) minutes from intranasal midazolam administration. The EDIN (Echelle de Douleur et Incomfort du Nouveau-né [newborn pain and discomfort score-in French]) pain score was calculated and various physiologic parameters were recorded. Data were analyzed with repeated measures ANOVA (analysis of variance). A total of 36 fundus examinations were performed in 27 noninvasively ventilated patients. The mean EDIN score went from 0.8 ± 1 at T0 to 0.72 ± 1.05 at T1, then to 0.22 ± 0.59 at T15, and to 0 ± 0 at T60 (p < 0.001). Thus, it remained below the threshold of 5, which is associated with significant pain. The mean heart rate decreased from 164 ± 16 at T0, to 161 ± 16 at T1, then to 154 ± 14 at T15, and to 153 ± 12 at T60 (p < 0.001). There was no significant change in the oxygen saturation/inspired oxygen fraction ratio across the four time points (p = 0.202) and the mean arterial pressure was similar before and after the administration of midazolam (60 ± 10 vs. 59 ± 10, p = 0.571). Intranasal midazolam provides good comfort and normal physiological parameters; therefore, the implementation of a NICU protocol to improve quality of retinal examinations seems feasible and well tolerated. · Fundus examinations did not cause pain after premedication with intranasal midazolam.. · No respiratory or circulatory adverse effect was reported.. · Implementing such a premedication protocol in the NICU seems feasible, helpful, and well tolerated..

Evaluation of the Efficacy of Nasal Sedation Midazolam Compared with Dexmedetomidine in the Management of Uncooperative Children with Down Syndrome during Dental Treatment.

Objective This study aimed to compare the intranasal administration of midazolam and dexmedetomidine in uncooperative children with Down syndrome. Materials and Methods The sample consisted of 20 children with Down syndrome aged 5 to 11 years who were divided equally into two groups: Group 1 (experimental) nasal dexmedetomidine and Group 2 (control) nasal midazolam. The efficacy of both the drugs was evaluated according to Ohio State University Behavioral Rating Scale (OSUBRS), University of Michigan scale (UMSS), and Houpt general behavior scale. Results Both substances have been effective in the management of children with Down syndrome. There were no statistically significant differences for Ohio State University Behavioral Rating Scale (OSUBRS) (P value = 0.631), University of Michigan scale (UMSS) (P value = 0.739), and Houpt general behavior scale (P value = 0.481). Conclusion Both midazolam and dexmedetomidine nasal can be used to sedate children with Down syndrome.

Comparison of intranasal dexmedetomidine and midazolam as premedication on haemodynamic stability

Background: Premedication in pediatric population helps to produce a relaxed state with reduced anxiety and increased. These pre-medications, midazolam and dexmedetomidine are effectively used as sedatives. The present study was planned to compare intranasal dexmedetomidine with intranasal midazolam as a pre-anesthetic medication in children. Fear of unpleasant and painful procedures, separation from parents and unwillingness to breathe through an anaesthesia face mask may produce stormy anaesthetic induction in unpremeditated patients. Because of this premedication should be an integral part of paediatric anaesthetic practice. Aims and Objectives: To evaluate the Intranasal administration of Midazolam and Dexmedetomidine as Premedication on Haemodynamic Stability among Paediatric Patients. Material &amp; Methods: This Comparative study was carried out at Department of Anaesthesiology, P K DAS Institute of Medical Sciences, Vaniamkulam, Ottapalam Kerala, India . A total of 70 Paediatric Patients of both sex age group between 1- 5 year from the routine surgical list of our Hospital were included in the study. The children were divided into two groups i.e. 35 in each based on the premedication received and by random allotted numbers.

Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review.

Objective: The objective of this study was to evaluate the efficacy and safety of intranasal midazolam as part of a paediatric sedation and analgesic procedure during the suturing of traumatic lacerations in paediatric emergency departments. Methodology: A systematic review of clinical trials was completed in July 2021. The databases consulted were PUBMED, SCOPUS, WEB OF SCIENCE, NICE and Virtual Health Library. Eligibility criteria: randomised and nonrandomised clinical trials. Two independent, blinded reviewers performed the selection and data extraction. The participants were 746 children, of whom, 377 received intranasal midazolam. All of the children were admitted to an emergency department for traumatic lacerations that required suturing. The quality of the articles was evaluated with the Jadad scale. This systematic review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: Nine studies were included in the review. The intranasal administration of midazolam in healthy children produces anxiolysis and minimal/moderate sedation without serious side effects. Although there are combinations of parenteral drugs that produce deeper sedation, they also have greater adverse effects. No significant differences in the initiation of sedation and the suture procedure were found between the intranasal route and the parenteral route. Conclusions: The use of intranasal midazolam in healthy children produces sufficiently intense and long-lasting sedation to allow for the suturing of traumatic lacerations that do not present other complications; therefore, this drug can be used effectively in paediatric emergency departments.

Clinical evaluation of the intranasal administration of midazolam and reverse effects of flumazenil in Eurasian Buzzards (Buteo buteo)

Midazolam, the most commonly used drug in birds, has sedative, muscle relaxant, anxiolytic, amnestic, and appetite-enhancing effects. In this study, we aimed to reach the proper sedation level with intranasal (IN) administration of midazolam, and quick and safe recovery with intranasal flumazenil application after a certain period of time. The buzzards in the experiment reached the desired and controllable sedation at 6.7 ± 1.6 min after administration of IN midazolam at a dose of 2 mg / kg of body weight. In the saline group (%0.9 NaCl), the doses of midazolam and flumazenil calculated according to their weight were administered intranasally as 0.9% NaCl. The heart rate was 290.4 ± 17.81 and 294.8 ± 18.19 beats/min in the midazolam group, and 300.8 ± 17.76 beats/min in the saline group. Cloacal temperature was 41.42 ± 07, 41.39 ± 0.85 °C in the midazolam group and 41.6 ± 0.45 °C in the saline group. The respiratory rate was 48.8 ± 4.5, 47.1 ± 4.3 breaths/min in the midazolam group and 54.6 ± 2.7 breaths/min in the saline group. Flumazenil was used as an antagonist at 0.05 mg/kg intranasally, and after 14.1 ± 1.8 minutes the sedation effect disappeared. Then the buzzards returned to their standard behavior. In conclusion, we suggest IN use of midazolam and use of flumazenil for faster recovery in buzzards as a simple, fast, practical, and economical mode of sedation for minimally invasive procedures.

Intranasal Fentanyl and Midazolam Use in Children 3 Years of Age and Younger in the Emergency Department.

Although the efficacy and safety profiles of both intranasal fentanyl and midazolam are well studied in pediatric patients, few studies examine their use in younger children. To examine and report our experiences in a pediatric emergency department (ED) with intranasal fentanyl and midazolam in children aged 3 years and younger. This retrospective study investigated intranasal fentanyl and midazolam administration, alone and in combination, in children 3 years and younger treated in a pediatric ED. Of 6198 patients included, 1762 received intranasal fentanyl alone, 1115 received intranasal midazolam alone, and 3321 received combination therapy. The median (interquartile range [IQR]) patient age was 2.2 (1.5-3) years. Initial median (IQR) fentanyl dose was 2.7 (2-3) µg/kg, with 13.3% receiving a repeat dose. Initial median (IQR) midazolam dose was 0.3 (0.2-0.3) mg/kg, with 3.3% receiving a second dose. Children receiving both fentanyl and midazolam had median (IQR) initial doses of 2.8 (2.1-3) µg/kg and 0.3 (0.2-0.3) mg/kg, respectively. Of these, 3.2% received repeat doses of both medications. Laceration repairs (33.8%) and incision and drainage (22.2%) accounted for the majority of indications. Only 2.9% (n = 178) received additional opioids. No serious adverse events requiring a reversal agent or respiratory support were reported. Intranasal fentanyl and midazolam, alone and in combination, can provide analgesia and anxiolysis to children aged 3 years and younger in the ED setting. Further prospective studies are needed to better evaluate their safety and efficacy in this younger population.

Effects of intramuscular and intranasal administration of midazolam–dexmedetomidine on sedation and some cardiopulmonary variables in New Zealand White rabbits

ObjectiveTo compare the sedative and cardiopulmonary effects of intranasal (IN) and intramuscular (IM) administration of dexmedetomidine and midazolam combination in New Zealand White rabbits. Study designA randomized, crossover experimental study. AnimalsA total of eight healthy New Zealand White rabbits, aged 6–12 months, weighing 3.1 ± 0.3 kg (mean ± standard deviation). MethodsThe animals were randomly assigned to administration of dexmedetomidine (0.1 mg kg–1) with midazolam (2 mg kg–1) by either IN or IM route separated by 2 weeks. The electrocardiogram, pulse rate (PR), peripheral haemoglobin oxygen saturation (SpO2), mean noninvasive arterial pressure (MAP), respiratory frequency (fR) and rectal temperature were measured before drug administration (baseline), T0 (onset of sedation) and at 5 minute intervals until recovery. The onset of sedation, duration of sedation and sedation score (SS) were also recorded. ResultsThe PR was significantly lower in treatment IM than in treatment IN over time (p = 0.027). MAP < 60 mmHg developed in two and four rabbits in treatments IN and IM, respectively. SpO2 progressively decreased over time in both treatments. fR was lower than baseline at several time points in both treatments. Onset of sedation was shorter in treatment IN (90 ± 21 seconds) than in treatment IM (300 ± 68 seconds) (p = 0.036). Duration of sedation was longer in treatment IM (55.2 ± 8.7 minutes) than in treatment IN (39.6 ± 2.1 minutes) (p = 0.047). No significant difference in SS was observed between treatments (p > 0.05). Conclusions and clinical relevanceCombination of dexmedetomidine (0.1 mg kg–1) and midazolam (2 mg kg–1) decreased fR, PR and SpO2 regardless of the administration route in New Zealand White rabbits. A more rapid action and shorter duration of sedation were observed after treatment IN than after treatment IM administration.

The Effectiveness of Intranasal Midazolam for the Treatment of Prehospital Pediatric Seizures: A Non-inferiority Study

Background: Intranasal (IN) midazolam allows for rapid, painless treatment of pediatric seizures in the prehospital setting and may be a preferred administration route if determined to be non-inferior to intravenous (IV) or intramuscular (IM) routes. We sought to evaluate the effectiveness of IN midazolam for terminating prehospital pediatric seizures compared to midazolam administered by alternate routes. Methods: We performed a retrospective, non-inferiority analysis using data from a regional Emergency Medical Services (EMS) database. We included pediatric patients ≤ 14 years treated with midazolam (0.1 mg/kg) by EMS for non-traumatic seizures. The primary outcome was the proportion of patients requiring redosing of midazolam after initial treatment with IN midazolam compared to those that received IV or IM midazolam. We established a priori a risk difference of 6.5% as the non-inferiority margin. Results: We evaluated outcomes from 2,034 patients (median age 6 years [interquartile range 3 − 10 years], 55% male). Initial administration routes were 461 (23%) IN, 547 (27%) IM, 1024 (50%) IV, and 2 (0.1%) intraosseous (IO). Midazolam redosing occurred in 116 patients (25%) who received IN midazolam versus 222 patients (14%) treated initially with midazolam via alternate routes (risk difference 11% [95%CI 7 − 15%]). The age-adjusted odds ratio for redosing midazolam after intranasal administration compared to alternate route administration was 2.0 (95% CI 1.6 − 2.6). Conclusion: Prehospital treatment of pediatric seizure with intranasal midazolam was associated with increased frequency of redosing compared to midazolam administered by other routes, suggesting that 0.1 mg/kg is a subtherapeutic dose for intranasal midazolam administration.

Comparison of preadministered and coadministered lidocaine for treating pain and distress associated with intranasal midazolam administration in children: A randomized clinical trial.

ObjectivePain and distress associated with intranasal midazolam administration can be decreased by administering lidocaine before intranasal midazolam (preadministered lidocaine) or combining lidocaine with midazolam in a single solution (coadministered lidocaine). We hypothesized coadministered lidocaine is non‐inferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration.MethodsRandomized, outcome assessor–blinded, noninferiority trial. Children aged 6 months to 7 years undergoing laceration repair received intranasal midazolam with preadministered or coadministered lidocaine. Pain and distress were evaluated with the Observational Scale of Behavioral Distress—Revised (OSBD‐R) (primary outcome; non‐inferiority margin 1.8 units) and the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Faces, Legs, Activity, Cry, Consolability (FLACC) scales and cry duration (secondary outcomes). Secondary outcomes also included adverse events, clinician and caregiver satisfaction, and pain and distress associated with intranasal lidocaine administration.ResultsFifty‐one patients were analyzed. Mean OSBD‐R scores associated with intranasal midazolam administration were 6.4 (95% confidence interval [CI] 5, 7.8) and 7 (95% CI 5.2, 8.9) units for preadministered and coadministered lidocaine, respectively. The difference of 0.6 (95% CI –1.7, 2.8) units represented an inconclusive non‐inferiority determination. CHEOPS and FLACC scores and cry duration were similar between groups. OSBD‐R, CHEOPS, and FLACC scores and cry duration associated with intranasal lidocaine administration were 3.8, 9.9, and 6 units, and 56 seconds, respectively. Clinicians considered coadministered lidocaine easier to administer.ConclusionPain and distress associated with intranasal midazolam administration were similar when using coadministered or preadministered lidocaine, but our non‐inferiority determination was inconclusive. Administration of intranasal lidocaine by itself was associated with a measurable degree of pain and distress.Keywords: intranasal, midazolam, anxiolysis, sedation, emergency department, emergency medicine, pain, distress, pediatric, lidocaine, laceration

WITHDRAWN: Comparison of Preadministered and Coadministered Lidocaine for Treating Pain and Distress Associated With Intranasal Midazolam Administration in Children: A Randomized Clinical Trial

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INTRANASAL MIDAZOLAM FOR THE TREATMENT OF SEIZURES IN CHILDREN IN RURAL INDIA

Background: About 5% of healthy children experience at least one convulsive episode in their lifetime with onset during childhood in more than half the cases. The current evidence suggests that prolonged seizures are best stopped with early treatment. Objective: The objective of the study was to assess the role of intranasal administration of midazolam for seizure cessation at home by caregiver in semi-urban and rural settings. Materials and Methods: A total of 50 children in the age group of 6 months–14 years were included in the study, who previously had a history of convulsions and were on regular follow-up. The study was conducted over a period of 6 months. The parents were instructed to give intranasal midazolam (INM) if seizure activity lasted for more than 3 minutes and the need of giving it 2nd time if the seizure was not aborted and to bring the child to nearest pediatrics emergency set up for the further management. Results: The subjects were divided into three groups according to age: Group A consisted of children between 6 months and 4 years, Group B of 4 and 9 years, and Group C had 9 and 14 years old children. Average duration of aborting seizures before INM use was 16.22 min and after its use was 4.66 min. Seizures were aborted in 45 children within 10 min. Conclusion: INM is safe and efficacious in aborting seizures at home in semi-urban and rural settings.

Comparative Analysis of Intravenous Midazolam with Nasal Spray for Conscious Sedation in Minor Oral and Maxillofacial Surgeries.

Aim:The aim of the current study was to evaluate the efficacy of nasal spray midazolam by collating it with conventional intravenous midazolam for conscious sedation in minor oral surgeries.Materials and Methods:Sixty patients were selected randomly and divided into two groups: group A for intranasal midazolam atomized spray (n = 30) and group B for intravenous midazolam (n = 30). Physiological parameters, anxiety score, sedation rating, patient’s cooperation score, and retrograde and anterograde amnesia were recorded for each patient during preoperative, intraoperative, and postoperative period. Final evaluation of safety and efficacy in the nasal and intravenous routes of midazolam drug during minor oral surgery was compared.Results:In this study, both intranasal and intravenous groups showed decrease in systolic blood pressure and diastolic blood pressure intraoperatively but within physiological limits and increase in the average pulse rates in both the groups. The average oxygen saturation levels were maintained to normal range in both the groups. The average respiratory rate decreased in both intranasal and intravenous groups during surgical procedure. The preoperative to postoperative anxiety scores were decreased significantly in the both groups and there was no significant difference in pre- to postoperative anxiety scores between the groups.Conclusion:Both intravenous and intranasal administration of midazolam showed better patient cooperation, satisfaction, and clinical effectiveness. Intranasal midazolam spray is effective in the reduction of subjective stress, reliable anxiolysis while preserving protective reflexes.

Quantification of Pain and Distress Associated With Intranasal Midazolam Administration in Children and Evaluation of Validity of Four Observational Measures.

The aims of this study were to quantify the pain and distress associated with the administration of intranasal (IN) midazolam in young children using 4 observational measures and to evaluate the degree of validity of these measures. We conducted a prospective observational pilot study. Children aged 1 to 7 years requiring IN midazolam were enrolled. Children were videotaped, and scores were assigned to baseline and administration phases using the Observational Scale of Behavioral Distress-Revised (OSBD-R), Children's Hospital of Eastern Ontario Pain Scale (CHEOPS), and the Faces-Legs-Activity-Cry-Consolability (FLACC) scale. The cry duration following administration was assessed. Interrater reliability and convergent validity were determined for all 4 measures. Internal consistency and responsivity for the OSBD-R, CHEOPS, and FLACC scales were determined. We enrolled 20 children. The mean OSBD-R, CHEOPS, and FLACC scores associated with administration of IN midazolam were 27.1 (SD, 13.5), 11.5 (SD, 1.2), and 8.9 (SD, 2.7), respectively. The mean cry duration was 105.5 (SD, 68.8) seconds. The intraclass correlation coefficients for all measures ranged from 0.82 to 0.99. The Cronbach α's for the OSBD-R, CHEOPS, and FLACC were between 0.71 and 0.97. Pearson correlation coefficients for comparisons between OSBD-R, CHEOPS, and FLACC were between 0.82 and 0.96 but were between 0.32 and 0.51 for comparisons involving cry duration. We have identified estimates of pain and distress associated with administration of IN midazolam in young children that can be used to determine desired effect sizes for trials that study interventions to treat this pain and distress. The OSBD-R, CHEOPS, and FLACC scales are suitable choices for outcome measures.

Adverse events and satisfaction with use of intranasal midazolam for emergency department procedures in children

PurposeProcedural sedation is commonly performed in the emergency department (ED). Having safe and fast means of providing sedation and anxiolysis to children is important for the child's tolerance of the procedure, parent satisfaction and efficient patient flow in the ED. ObjectiveTo evaluate fasting times associated with the administration of intranasal midazolam (INM) and associated complications. Secondary objectives included assessing provider and caregiver satisfaction scores. MethodsA prospective observational study was conducted in children presenting to an urban pediatric emergency department who received INM for anxiolysis for a procedure or imaging. Data collected included last solid and liquid intake, procedure performed, sedation depth, adverse events and parent and provider satisfaction. Results112 patients were enrolled. The mean age was 3.8 years. There were no adverse events experienced by any patients. Laceration repair was the most common reason for INM use. The median depth of sedation was 2.0 (cooperative/tranquil). The median liquid NPO time was 172.5 min and the median NPO time for solids was 194.0 min. 29.8% were NPO for liquids ≤2 h and 62.5% were NPO for solids ≤2 h. Parent and provider satisfaction was high: 90.4% of parents' and 88.4% of providers' satisfaction scores were a 4 or 5 on a 5 point Likert scale. ConclusionOur data suggest that short NPO of both solids and liquids are safe for the use of INM. Additionally, parent and provider satisfaction scores were high with the use of INM.