Treatment of out-of-hospital status epilepticus with diazepam rectal gel

Fitzgerald, Brian; Okos, A; Miller, John W.

doi:10.1016/s105913110200170x

Cited by 27 publications

(11 citation statements)

References 14 publications

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“…Management of these emergencies has markedly improved since the advent of out‐of‐hospital treatments such as rectal diazepam (Dieckmann, 1994; Alldredge et al., 2001; Kapur, 2002; Fitzgerald et al., 2003). There are physical and social constraints to the use of the rectal route.…”

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confidence: 99%

A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations

et al. 2010

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SUMMARYRectal diazepam is established as a standard rescue or emergency treatment for seizure or status epilepticus; however, the rectal route of administration has not been universally accepted. To determine if an alternative route of administration of a benzodiazepine was equally effective, we compared a novel midazolam HCl concentrated nasal spray (MDZ-n) with diazepam rectal solution (DZP-r) in the treatment of prolonged seizures in a residential epilepsy center. In 21 adult patients with medically refractory epilepsy, 124 seizureexacerbations were treated by their caregivers, alternatively with 10 mg DZP-r and 10 mg concentrated MDZ-n, two or three treatments with each medication for each patient. No difference was demonstrated in efficacy or time to effect between the two drugs. Common treatment emerging adverse effects were drowsiness for both drugs in more than 50% of the administrations, and short-lasting local irritation after 29% of MDZ-n. No severe adverse events occurred. The nasal spray was preferred to the rectal solution by 16 of 21 caregivers and patients conjointly. MDZ-n was equal to DZP-r with respect to efficacy and side effects in the suppression of seizure exacerbations. The majority of patients and caregivers preferred the nasal spray over the rectal formulation.

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confidence: 99%

A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations

et al. 2010

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“…From Table 3, according to r 2 and n values, the release kinetic model of all suppositories complies with Higuchi and Cross Mayer Peppas. In all formulas, n is bigger than 0.45 and smaller than 0.89, this indicates a non-Fickian diffusion [18].…”

Section: Kinetic Analysis Resultsmentioning

confidence: 71%

Preparation and in Vitro Evaluation of Fast Release Diazepam Suppositories for Febrile Seizures

Alsamman

Othman

2017

Asian J Pharm Clin Res

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Objective: The objective of this study was to optimize the best formula for fast release suppositories of diazepam.Methods: Suppositories were prepared by fusion method using Witepsol H15 as oleaginous base, polyethylene glycol as a water-soluble polymer, and Poloxamer 188 as water miscible base. All suppositories were evaluated for physical characteristics, in vitro drug release and kinetic models. The effects of incorporating Tween 80 as a non-ionic surfactant, propylene glycol as a cosolvent, and effervescent pair on the release rate of diazepam from suppositories were investigated. Differential scanning calorimetry and Fourier transform infrared spectrometry were used to characterize physical mixtures of diazepam and the different used bases.Results: Many formulations of diazepam have been prepared and in vitro evaluated. PEG suppositories released diazepam more efficiently than poloxamer and witepsol suppositories. The including of an effervescent pair in the formulation of suppositories greatly enhanced the release of diazepam. The addition of tween 80 to witepsol suppositories, PG to poloxamer suppositories, increased the rate and extent of diazepam release. Conclusion:Fast release of diazepam has been obtained from suppositories containing the effervescent pair (formula F3), which also have good physical properties.

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Section: Discussionmentioning

confidence: 99%

“…Rectal diazepam emerged as the primary treatment option for breakthrough seizures in the past. However rectal diazepam has slower onset of action than the intravenously delivered drug and is not as effective at controlling seizures (10).Other disadvantages include low social acceptability and high cost of the commercial preparation [10][11][12].Intranasal (I/N) midazolam was safe and effective in numerous clinical trials [13][14][15][16][17][18][19]. On I/N route drug is directly absorbed into the blood and CSF via nasal mucosa.…”

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confidence: 99%

Buccal Clonazepam versus Intravenous (I/V) Midazolam for Management of Acute Breakthrough Seizure –A Randomized Controlled Trial

Kumar¹

2016

JPNC

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Objectives: To compare efficacy and safety of buccal Clonazepam with I/V Midazolam in acute seizure therapy. Methods:A prospective, open label randomized controlled trial done on children with acute breakthrough seizure in known epileptics .200 breakthrough episodes were randomized to inject able midazolam (0.2mg/kg) or buccal clonazepam (0.01mg/kg) given on even days (IV Midazolam) and odd days (buccal Clonazepam).Results: Ninety two (92.0%) seizures were controlled IV Midazolam and eighty six (86.0%) in buccal Clonazepam group. No statistical significant (p=0.175) was observed .Recurrence after initial control was 8.0% in IV Midazolam and 9.0% in buccal Clonazepam group with no statistical significant (p=0.800) .Vital monitoring parameters maintained in both groups .16.0% revealed adverse reactions 10 min post drug administration, 4.0% in the midazolam, and 12.0% in clonazepam group (p value=0.119). Adverse effects required no intervention. Conclusions MonitoringPatients were monitored for vital parameters including heart rate, respiratory rate, blood pressure, saturation for ten minutes. The side effects of each drug were compared in different age groups with different semiology and etiology of seizures. We used Clonazepam (0.25/0.50/1.00mg) mouth dissolving dispersible clonazepam tablets. Statistical AnalysisData was recorded on a predesigned proforma and it was managed on a Microsoft Excel spread sheet. Statistical analysis was performed using software between the 2 groups: IV Midazolam and Buccal clonazepam. Categorical variables were summarized by frequency .Proportions were compared by chi-square test or Fisher's exact test (where expected frequency <5). Continuous variables having a normal distribution were summarized by mean and standard deviation; for others median was used .for continuous variables, student's 't' test , Mann Whitney U test or Wilcoxon signed rank sum test were applied as appropriate .P value of <0.05 was taken as significant . ResultsThe baseline characteristics of two drug groups with respect to age, sex, etiology of seizures, types of seizure, duration of seizure,EEG,neuroimaging were statistically comparable (

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Treatment of out-of-hospital status epilepticus with diazepam rectal gel

Cited by 27 publications

References 14 publications

A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations

A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations

Preparation and in Vitro Evaluation of Fast Release Diazepam Suppositories for Febrile Seizures

Buccal Clonazepam versus Intravenous (I/V) Midazolam for Management of Acute Breakthrough Seizure –A Randomized Controlled Trial

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