A Comparison of Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures

Dreifuss, Fritz E.; Rosman, N. Paul; Cloyd, James C.; Pellock, John M.; Kuzniecky, Ruben; Lo, Warner; Matsuo, Fumisuke; Sharp, Gregory B.; Conry, Joan A.; Bergen, Donna; Bell, Walter E.

doi:10.1056/nejm199806253382602

Cited by 254 publications

(195 citation statements)

References 30 publications

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“…Respiratory depression after rectal administration of diazepam in children was reported in five class III trials, ranging from 1.2 percent to 6.4 percent (35,41,42,45,47), while two class III trials (37,40) and two class I trials in acute repetitive seizures (59,60) reported no incidence of respiratory depression with rectal diazepam use in children. No respiratory depression was reported in one study of six children treated with rectal lorazepam (35).…”

Section: Pediatric Studiesmentioning

confidence: 99%

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

Glauser

Shinnar

Gloss³

et al. 2016

Epilepsy Curr

948

937

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CONTEXT: The optimal pharmacologic treatment for early convulsive status epilepticus is unclear. OBJECTIVE: To analyze efficacy, tolerability and safety data for anticonvulsant treatment of children and adults with convulsive status epilepticus and use this analysis to develop an evidence-based treatment algorithm. DATA SOURCES: Structured literature review using MEDLINE, Embase, Current Contents, and Cochrane library supplemented with article reference lists. STUDY SELECTION: Randomized controlled trials of anticonvulsant treatment for seizures lasting longer than 5 minutes. DATA EXTRACTION: Individual studies were rated using predefined criteria and these results were used to form recommendations, conclusions, and an evidence-based treatment algorithm. RESULTS: A total of 38 randomized controlled trials were identified, rated and contributed to the assessment. Only four trials were considered to have class I evidence of efficacy. Two studies were rated as class II and the remaining 32 were judged to have class III evidence. In adults with convulsive status epilepticus, intramuscular midazolam, intravenous lorazepam, intravenous diazepam and intravenous phenobarbital are established as efficacious as initial therapy (Level A). Intramuscular midazolam has superior effectiveness compared to intravenous lorazepam in adults with convulsive status epilepticus without established intravenous access (Level A). In children, intravenous lorazepam and intravenous diazepam are established as efficacious at stopping seizures lasting at least 5 minutes (Level A) while rectal diazepam, intramuscular midazolam, intranasal midazolam, and buccal midazolam are probably effective (Level B). No significant difference in effectiveness has been demonstrated between intravenous lorazepam and intravenous diazepam in adults or children with convulsive status epilepticus (Level A). Respiratory and cardiac symptoms are the most commonly encountered treatment-emergent adverse events associated with intravenous anticonvulsant drug administration in adults with convulsive status epilepticus (Level A). The rate of respiratory depression in patients with convulsive status epilepticus treated with benzodiazepines is lower than in patients with convul-

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Section: Pediatric Studiesmentioning

confidence: 99%

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

Glauser

Shinnar

Gloss³

et al. 2016

Epilepsy Curr

948

937

View full text Add to dashboard Cite

show abstract

“…A new form of treatment for acute seizure activity that may be used at home is diazepam administered in a rectal solution, but this is approved for use in selected refractory patients to control acute, repetitive seizure activity and is not used after a single unprovoked seizure. 64,65 Summary. Whereas evidence from studies of treatment after only a single unprovoked seizure is lacking, Class I and II evidence concerning the AED accepted for use as first-line anticonvulsants in children (PB, PHT, VPA, CBZ) indicates that clinically relevant cognitive and behavioral effects may occur, particularly with PB.…”

Section: What Are the Nature And Frequency Of Side Effects Of Aed Commentioning

confidence: 99%

Practice parameter: Treatment of the child with a first unprovoked seizure

Hirtz¹,

Berg²,

Bettis³

et al. 2003

Neurology

181

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Abstract-The Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society develop practice parameters as strategies for patient management based on analysis of evidence regarding risks and benefits. This parameter reviews published literature relevant to the decision to begin treatment after a child or adolescent experiences a first unprovoked seizure and presents evidence-based practice recommendations. Reasons why treatment may be considered are discussed. Evidence is reviewed concerning risk of recurrence as well as effect of treatment on prevention of recurrence and development of chronic epilepsy. Studies of side effects of anticonvulsants commonly used to treat seizures in children are also reviewed. Relevant articles are classified according to the Quality Standards Subcommittee classification scheme. Treatment after a first unprovoked seizure appears to decrease the risk of a second seizure, but there are few data from studies involving only children. There appears to be no benefit of treatment with regard to the prognosis for long-term seizure remission. Antiepileptic drugs (AED) carry risks of side effects that are particularly important in children. The decision as to whether or not to treat children and adolescents who have experienced a first unprovoked seizure must be based on a risk-benefit assessment that weighs the risk of having another seizure against the risk of chronic AED therapy. The decision should be individualized and take into account both medical issues and patient and family preference. NEUROLOGY 2003;60:166 -175 Population-based studies of the incidence of first unprovoked seizures suggest that there are between 25,000 and 40,000 children per year in the United States who experience a first unprovoked seizure. [1][2][3][4] Until relatively recently, it was common practice for physicians to begin long-term, daily antiepileptic drug (AED) therapy after a child or adolescent experienced a single seizure of any type. The rationale for this practice was based on the belief that all seizures were likely to recur and that seizures could be dangerous and cause brain damage. Furthermore, it was thought that if any recurrence were to take place, this would lead to progressively more seizures. It was also assumed that AED were safe, had few side effects, and were effective in prevention of seizure recurrences. These assumptions have undergone substantial modification over the last 20 years, leading to a more optimistic view about the nature of seizures and a more conservative approach to the use of treatment. However, no clear evidence-based guidelines have emerged regarding the initiation of treatment after a first unprovoked seizure in the pediatric population.Practice parameters are developed by the Quality

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“…[11][12][13][14][15][16] However, it requires a patient to be partially undressed, which can be viewed as problematic for the patient, school staff, and other students, especially in partially conscious students when there is no ready means of privacy to preserve the patient's dignity. Families may appreciate consultation about these issues before formulation and implementation of an action plan.…”

Section: Rectal Diazepam Gelmentioning

confidence: 99%

Rescue Medicine for Epilepsy in Education Settings

Devore¹,

Kang²,

Gilbert³

et al. 2016

Pediatrics

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Children and adolescents with epilepsy may experience prolonged seizures in school-associated settings (eg, during transportation, in the classroom, or during sports activities). Prolonged seizures may evolve into status epilepticus. Administering a seizure rescue medication can abort the seizure and may obviate the need for emergency medical services and subsequent care in an emergency department. In turn, this may save patients from the morbidity of more invasive interventions and the cost of escalated care. There are signifi cant variations in prescribing practices for seizure rescue medications, partly because of inconsistencies between jurisdictions in legislation and professional practice guidelines among potential fi rst responders (including school staff). There also are potential liability issues for prescribers, school districts, and unlicensed assistive personnel who might administer the seizure rescue medications. This clinical report highlights issues that providers may consider when prescribing seizure rescue medications and creating school medical orders and/or action plans for students with epilepsy. Collaboration among prescribing providers, families, and schools may be useful in developing plans for the use of seizure rescue medications.

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A Comparison of Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures

Abstract: Rectal diazepam gel, administered at home by trained care givers, is an effective and well-tolerated treatment for acute repetitive seizures.

Cited by 254 publications

References 30 publications

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

Practice parameter: Treatment of the child with a first unprovoked seizure

Rescue Medicine for Epilepsy in Education Settings

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