scholarly journals Assessing efficacy and safety of buccally inoculated midazolam and intravenously administered diazepam for relieving pediatric primary generalized epileptic seizures

2021 ◽  
Vol 13 (2) ◽  
pp. 97-105
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  

Objective: to confirm a therapeutic equivalence and similar safety profile of “Midazolam, oromucosal (buccal) solution” and “Sibazon, solution for intravenous and intramuscular administration” used in children aged from 1 year to 18 years suffering from primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted with 25 patients having primary generalized and bilateral tonic, clonic and tonic-clonic seizures due to epilepsy or epileptic syndrome. The study used age-appropriate doses of Midazolam with a single buccal administration as well as diazepam (Sibazon) for single intramuscular administration. Midazolam dosing was as follows: 5 mg for children of the younger age group (1 tube-dropper 5 mg/ml), 7.5 mg for children of the middle age group (1 tube-dropper 5 mg/ml and 1 tube-dropper 2.5 mg/ml), 10 mg for older children (2 tube-droppers 5 mg/ml). The drug effectiveness was assessed by primary and secondary criteria. The number of cases of drug administration in each group was used as the primary criteria, in which the convulsions ended up within 10 minutes after using the drug and did not resume within 60 minutes after drug administration. The following criteria were used as secondary: no repeated convulsive seizures within 24 hours after drug administration, no repeated convulsive seizure within 48 hours after drug administration, time before repeated convulsive seizure within 48 hours after drug administration. Clinical assessment was carried out according to clinical data, electroneurophysiologic (electroencephalographic) studies, electrocardiography, clinical blood and urine tests, aswell as biochemical blood tests by measuring glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, and creatinine clearance level.Results. Compliance with the first efficacy criterion after using Midazolam and Sibazon was observed in 11 (84.6%) and 9 (75%) patients in Group 1 and Group 2, respectively, showing insignificant differences (Fisher's exact test (FET): p=0.645). The number of no cases of repeated convulsive seizure within 24 hours after drug administration differed significantly and was 12 (92.3%) and 6 (50%), respectively (FET: p=0.030). The number of cases with no second seizures within 48 hours after drug administration in Group 1 and Group 2 was 12 (92.3%) and 5 (41.7%), respectively, showing insignificant differences (FET: p=0.0112). No serious adverse events were reported during the study. No patients cancelled participation in the study due to developed adverse event.Conclusion. The data obtained evidence about compatibility of therapeutic efficacy profile and similar safety profile for “Midazolam, oromucosal (buccal) solution” and “Sibazon, solution for intravenous and intramuscular administration” that agrees with multiple data of earlier studies.

2021 ◽  
Vol 13 (3) ◽  
pp. 200-210
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  

Objective: to prove the therapeutic equivalence and similar safety profile of “Sibazon, rectal solution” (international nonproprietary name: diazepam) and “Sibazon, solution for intravenous and intramuscular administration” in children with primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted in 20 patients suffering from epilepsy with generalized seizures aged 1 to 17 years. Clinical blood and urine tests, biochemical blood analysis were used for diagnostics (glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, creatinine clearance), as well as data on electrocardiographic (ECG) and electroencephalographic (EEG) studies. The patients were divided into two groups: in Group 1 (n=8), a rectal solution was used, in Group 2 (n=12) – a solution for intravenous and intramuscular administration.Results. The number of cases in which seizures were completed within 10 minutes after using the drug without resuming within subsequent 60 minutes, in Group 1 was 7 (87.5%), and in Group 2 – 9 (75.0%) (Fisher exact test (FET): p=0.617). Repeated primary generalized or bilateral tonic/clonic/tonic-clonic seizures within 24 hours after drug administration, in Group 1 were absent in 5 (62.5%) patients, in Group 2 – in 6 (50%) (FET: p=0.670); within 48 hours after drug administration – in 5 (62.5%) and 7 (58.3%) children, respectively (FET: p=1.00). Physical examination revealed no pathology in all patients at the final visit. While comparing ECG and EEG data at the final visit, no inter-group differences were found by the number of children with deviations from the norm. The results of laboratory studies confirmed that using the studied drugs had no negative effect on the main indicators of clinical and biochemical blood tests as well as clinical urine analysis.Conclusion. The effectiveness of the rectal form of Sibazon in relieving pediatric generalized epileptic seizures is comparable to that of Sibazon for intramuscular administration. The drug rectal form, due to easy-to-use administration, is preferable for outpatient practice. “Sibazon, rectal solution” is safe and has good tolerability.


2014 ◽  
Vol 25 (4) ◽  
pp. 211-216 ◽  
Author(s):  
Francisco Noya ◽  
Deirdre McCormack ◽  
Donna L Reynolds ◽  
Dion Neame ◽  
Philipp Oster

OBJECTIVES:To describe the immunogenicity and safety of a two-dose series of a quadrivalent meningococcal (serogroups A, C, Y and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) administered to toddlers.METHODS: Children were randomly assigned (1:1) at study entry to receive MenACYW-D at 12 and 18 months of age (group 1; n=61) or meningococcal serogroup C conjugate vaccine (MCC) at 12 months of age (group 2; n=62). All received routine childhood immunizations. A, C, Y and W antibody titres were measured in group 1 before and one month after the 18-month MenACYW-D vaccination and were measured in group 2 at one and seven months post-MCC vaccination. Antibodies elicited by diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine andHaemophilus influenzaeb conjugate (DTaP-IPV-Hib) vaccine coadministered at the 18-month vaccination were measured one month later. Safety data were collected.RESULTS: At 19 months of age, ≥96% in group 1 achieved protective titres for the four meningococcal serogroups after dose 2; 67% in group 2 exhibited protective titres against serogroup C 28 days after MCC vaccination at 12 months of age, declining to 27% seven months later. DTaP-IPV-Hib elicited high antibody concentrations/titres in groups 1 and 2, consistent with historical values. The safety profiles after each dose generated no unexpected safety signals; no serious adverse events were related to vaccination.DISCUSSION: A two-dose series of MenACYW-D given concomitantly with a DTaP-IPV-Hib booster dose at 18 months of age demonstrated a good immunogenicity and safety profile. A two-dose series of MenACYW-D can be used as an alternative to one dose of MCC and provides protection against additional serogroups (NCT ID: NCT01359449).


Author(s):  
Milena Kostadinovic ◽  
Dejan Nikolic ◽  
Ivana Petronic ◽  
Dragana Cirovic ◽  
Mirko Grajic ◽  
...  

We aimed to evaluate the prevalence of sociodemographic factors with the presence and different degrees of walking difficulties in elderly above 65 years, and to analyze association between evaluated variables and the presence and degree of waking difficulties. In the population based study, 3540 individuals age above 65 years from Serbia were recruited. Further predictors were analyzed: gender, age, level of education, marital status, body mass index (BMI), index of well-being and place of residence. We assessed difficulty in walking half a km on level ground without the use of any aid (Group-1); and difficulty in walking up or down 12 steps (Group-2). Walking difficulties were categorized as no difficulty, some difficulty, a lot of difficulty and cannot do at all. For present difficulty significant predictors were: age (Group-1 (OR-3.022)/Group-2 (OR-3.825)), gender (Group-1 (OR-0.337)/Group-2 (OR-0.311)), educational level (Group-1 (OR-0.689)/Group-2 (OR-0.556)) and place of residence (Group-2 (OR-1.523)) while for non-performing the task, significant predictors were: age (Group-1 (OR-1.998)/Group-2 (OR-2.096)), gender (Group-1 (OR-0.629)/Group-2 (OR-0.495)), BMI (Group-1 (OR-1.219)/Group-2 (OR-1.305)), marital status (Group-1 (OR 0.764)/Group-2 (OR-0.769)), educational level (Group-1 (OR-0.679)/Group-2 (OR-0.719)) and index of well-being (Group-2 (OR-0.764)). Understanding of predictors, and their role on functional decline in elderly is of great importance for the development of specific population-based health programs to prevent further functional loss and preserve achieved functional gains.


PEDIATRICS ◽  
1978 ◽  
Vol 62 (3) ◽  
pp. 294-298 ◽  
Author(s):  
Robert Hodgkinson ◽  
M. Bhatt ◽  
G. Grewal ◽  
G. F. Marx

The early neonatal neurobehavioral scale ‘was administered to three groups of newborns at 2, 4, and 24 hours of age. Group 1 consisted of 28 babies whose mothers had received no narcotics during labor, group 2 of 33 babies whose mothers had received meperidine hydrochloride alone during labor, and group 3 of 40 babies whose mothers had received meperidine followed by 0.4 mg of naloxone hydrochloride intravenously approximately 15 minutes before delivery. Babies who were not exposed to meperidine showed a statistically significantly greater percentage of high scores than those exposed to meperidine alone for all items on the neurobehavioral scale at 2 and 4 hours and for all items except tone and Moro response at 24 hours. Similarly, babies whose mothers had received meperidine and naloxone showed a significantly greater percentage of high scores than those whose mothers had received meperidine alone at 2 hours of age. At 4 hours a difference was found for tone and rooting and at 24 hours for overall score, placing, and total decrement score. It is concluded that naloxone given intravenously to the mother reverses the effect of meperidine on neonatal neurobehavior for approximately two hours after birth. At 4 and 24 hours, however, the neurobehavior of neonates exposed to meperidine and naloxone is depressed almost as much as that of babies exposed to meperidine alone.


2019 ◽  
Vol 1 (3) ◽  
pp. 53-60
Author(s):  
I. V. Feldblyum ◽  
V. V. Romanenko ◽  
M. G. Menshikova ◽  
I. A. Okuneva ◽  
A. E. Makarov ◽  
...  

Aim is comparative evaluation of the safety and immunogenicity of inactivated poliomyelitis vaccine (IPV) «Bilthoven Biologicals B.V.» (Netherlands) and «Imovax Polio» (France) with subcutaneous and intramuscular modes of administration. Materials and methods. In a doubleblind, comparative clinical randomized multicenter study, 120 children at the age of 3 months participated as volunteers. They were divided into 4 groups: 1 and 2 groups were given IPV intramuscular (group 1) and subcutaneous (group 2) mode of administration, children of groups 3 and 4 were given the vaccine «Imovax Polio». Results. IPV is characterized by a high safety profile and immunogenicity both in subcutaneous and intramuscular modes of administration and it is comparable in its characteristics with the vaccine «Imovax Polio». Conclusion. Vaccine IPV (Netherlands) is recommended for registration in the territory of the Russian Federation and its further using in the National Vaccination Schedule.


Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384


2021 ◽  
Vol 11 (2) ◽  
pp. 28-34
Author(s):  
D. A. Grishina ◽  
N. A. Suponeva

Background. The study of the sensitive portion of the medial plantar nerve is relevant not only in the examination of patients with tibial nerve mononeuropathy or its branches, but also in the diagnosis of polyneuropathies.Objective: to analyze the normative parameters of the sensory potential recorded during the study of the medial plantar nerve by the orthodromic method in healthy adults.Materials and methods. 126 sensitive fibers of the medial plantar nerves were studied on the Dantec Keypoint G4 device (Denmark) in 63 healthy individuals (31 men and 32 women; age from 20 to 80 years). 3 groups were identified taking into account age: group 1 included healthy people aged 20 to 39 years (n = 23); group 2 consisted of people aged 40 to 60 years (n = 20); and 3 – older than 60 years (n = 20). The parameters of the sensory potential of the medial plantar nerve are analyzed.Results. The sensory potential in the study of the sensitive portion of the medial plantar nerve was registered in all 126 healthy subjects. Comparative statistical analysis did not demonstrate significant differences between groups 1–3 in the values of such parameters of the sensory potential as the latency of the onset, the duration of the negative phase and the rate of propagation of excitation. At the same time, in groups 2 and 3, the magnitude of the amplitude from peak to peak of the sensory potential was significantly lower compared to group 1, and averaged 8.92 and 7.86 MV, respectively.Conclusion. Knowledge of the regulatory parameters will allow expanding the use of electroneuromyography of the sensitive portion of the medial plantar nerve in clinical and research practice.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
G Zucchelli ◽  
V Barletta ◽  
F Fiorentini ◽  
...  

Abstract Introduction the management of patients with infection or malfunction of a cardiac implantable electronic device (CIED) may be challenging. Purpose The aim of the study is to evaluate the safety and efficacy of transvenous lead extraction (TLE) in elderly patients. Methods a retrospective analysis of patients who underwent to TLE in our center was performed. Patients were divided in two groups: 1) patients 80 years of age or older, 2) patients younger than 80 years. All patients were treated with manual traction or mechanical dilatation. Results our analysis included 1316 patients, with a total of 2513 leads extracted. Group 1 (≥80 years) counted 202 patients and group 2 (<80 years) 1114 patients. The group of elderly patients presented more comorbidities, as hypertension, chronic kidney disease, atrial fibrillation and pulmonary disease. Patients 80 years of age or older had more pacemakers than ICDs, whereas the dwelling time of the oldest lead, the number of leads and the presence of abandoned leads was similar despite patients age. In group 1 the rate of radiological success for lead was higher than in group 2 (99.0% vs 95.9%; P < 0.001). The clinical success was obtained in 1273 patients (96.7%), without significative differences between groups (98.0% vs 96.4%; P = 0.36). Major complications occurred in 10 patients (0.7%), without significative differences (1.5% vs 0.6%; P = 0.24) (figure 1). Conclusion TLE in elderly patients is a safe and effective procedure. In patients older than 80 years there are not more major complications than in younger patients, and the efficacy of the procedure seems to be superior. Abstract Figure 1


2020 ◽  
Vol 8 (6) ◽  
pp. 232596712092793
Author(s):  
Christopher Antonacci ◽  
Thomas R. Atlee ◽  
Peter N. Chalmers ◽  
Christopher Hadley ◽  
Meghan E. Bishop ◽  
...  

Background: Pitching velocity is one of the most important metrics used to evaluate a baseball pitcher’s effectiveness. The relationship between age and pitching velocity after a lighter ball baseball training program has not been determined. Purpose/Hypothesis: The purpose of this study was to examine the relationship between age and pitching velocity after a lighter ball baseball training program. We hypothesized that pitching velocity would significantly increase in all adolescent age groups after a lighter baseball training program, without a significant difference in magnitude of increase based on age. Study Design: Cohort study; Level of evidence, 2. Methods: Baseball pitchers aged 10 to 17 years who completed a 15-week training program focused on pitching mechanics and velocity improvement were included in this study. Pitchers were split into 3 groups based on age (group 1, 10-12 years; group 2, 13-14 years; group 3, 15-17 years), and each group trained independently. Pitch velocity was assessed at 4 time points (sessions 3, 10, 17, and 25). Mean, maximum, and mean change in pitch velocity between sessions were compared by age group. Results: A total of 32 male baseball pitchers were included in the analysis. Mean/maximum velocity increased in all 3 age groups: 3.4/4.8 mph in group 1, 5.3/5.5 mph in group 2, and 5.3/5.2 mph in group 3. While mean percentage change in pitch velocity increased in all 3 age groups (group 1, 6.5%; group 2, 8.3%; group 3, 7.6%), the magnitude of change was not significantly different among age groups. Program session number had a significant effect on mean and maximum velocity, with higher mean and maximum velocity seen at later sessions in the training program ( P = .018). There was no interaction between age and program session within either mean or maximum velocity ( P = .316 and .572, respectively). Conclusion: Age had no significant effect on the magnitude of increase in maximum or mean baseball pitch velocity during a velocity and mechanics training program in adolescent males.


Author(s):  
Hemavathi G. ◽  
Jagruthi C.

Background: Mid trimester termination of pregnancy is one of the most controversial areas of gynecological practice. It has moral, emotional, social and technical issues. This study was designed for comparison of efficacy and safety of Mifepristone-Misoprostol combination with exrtaamniotic Ethacridine Lactate-misoprostol for termination of second trimester pregnancy.Methods: The present was undertaken among the patients admitted to hospitals attached to J.J.M. Medical College; Bapuji hospital, Women and Children hospital and Chigateri general hospital Davangere during the study period   from November 2016 - October 2017.  Patients coming for second trimester abortion to above mentioned hospitals were assigned serial number from 1 to 80 and all patients with even number will be allocated to group 1 and all patients with odd number will be allocated in group 2, each group comprising 40 women each.Results: Majority of the cases in both the groups were between 21-25 yrs. Majority of the cases in both the groups were multigravidas. 11 cases from group 1 and 12 cases from group 2 were of gestational age between 14-16 wks. 29 cases from group 1 and 28 cases from group 2 were of gestational age between 18-20 wks. In the present study the mean induction abortion interval for group 1 was 19.56±1.82 hours and group 2 was 14.13±2.72 hours. This was statistically significant. Of the 40 cases in each group, 37 had complete abortion i.e. 92.5% 3 cases (7.5%) from both the groups had incomplete abortion. The side effects were relatively more in more in group 1 when compared to group 2.Conclusions: It was concluded that with this combination success rate was high (92.5 %), with Short induction abortion interval, less rate of incomplete abortion without any major complications.


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