Elsevier

Pediatric Neurology

Volume 34, Issue 5, May 2006, Pages 355-359
Pediatric Neurology

Original article
Intranasal Midazolam vs Rectal Diazepam in Acute Childhood Seizures

https://doi.org/10.1016/j.pediatrneurol.2005.09.006Get rights and content

One hundred eighty-eight seizure episodes in 46 children were randomly assigned to receive treatment with rectal diazepam and intranasal midazolam with doses of 0.3 mg/kg body weight and 0.2 mg/kg body weight, respectively. Efficacy of the drugs was assessed by drug administration time and seizure cessation time. Heart rate, blood pressure, respiratory rate, and oxygen saturation were measured before and after 5, 10, and 30 minutes following administration of the drugs in both groups. Mean time from arrival of doctor to drug administration was 68.3 ± 55.12 seconds in the diazepam group and 50.6 ± 14.1 seconds in the midazolam group (P = 0.002). Mean time from drug administration to cessation of seizure was significantly less in the midazolam group than the diazepam group (P = 0.005). Mean heart rate and blood pressure did not vary significantly between the two drug groups. However, mean respiratory rate and oxygen saturation differed significantly between the two drug groups at 5, 10, and 30 minutes after drug administration. Intranasal midazolam is preferable to rectal diazepam in the treatment of acute seizures in children. Its administration is easy, it has rapid onset of action, has no significant effect on respiration and oxygen saturation, and is socially acceptable.

Introduction

Seizure, a common neurologic medical emergency, continues to be associated with significant morbidity and mortality in the pediatric age group and affects 4-7% of children [1]. Early domiciliary treatment of seizures in the community, school, or home with drugs that can be administered by parents, teachers, or nonmedical staff may be beneficial and can decrease morbidity and mortality [2]. In planning domiciliary therapy, the safety, ease of administration, choice of drug, route of therapy, and the practicability of familiarization by the user are important issues. Various drugs administered through different routes have been tried in the management of acute seizures.

Rectal diazepam has been used successfully for home and hospital treatment of acute seizures [3]. Its use may be socially embarrassing and undesirable. Moreover, some special arrangement is required to administer it, which is difficult to arrange in homes, schools, and daycare centers. An effective treatment that can be easily administered by a more convenient, socially acceptable route is therefore needed.

Midazolam, a benzodiazepine, has been described as an alternative rescue medication in the management of acute seizures [4], [5]. Recent studies have demonstrated intranasal midazolam to be effective in the management of acute childhood seizures [6], [7], [8], [9], [10]. However, not many comparative studies have been undertaken, and the search for an easily administrable, effective drug to control acute seizure continues.

In the light of the above background, the present study was undertaken to compare the efficacy and side effects of intranasal midazolam and rectal diazepam in the treatment of acute childhood seizures.

Section snippets

Materials and Methods

This study was a randomized, controlled, single masked study. All types of seizures including febrile seizures and all types of epilepsy in children of either sex, ages 3 months to 12 years, who attended the Institute’s outpatient department or emergency were included in the study. A written consent was obtained from the parents or guardians of children regarding their willingness to participate in the study. The study was approved by the Institute ethical committee.

Drugs used in this study

Results

Of 188 seizure episodes in 46 children under study, 96 episodes were treated with rectal diazepam and 92 with intranasal midazolam. The diagnoses of these 46 children and the type of seizures are summarized in Table 1 and Table 2, respectively. Comparative baseline characteristics of the two groups under study are presented in Table 3A, Table 3B.

After comparing the baseline characteristics between the two groups, which did not vary significantly, an analysis of the 188 seizure episodes (96

Discussion

Early termination of seizures is important to prevent many adverse consequences and reduce the risk of development of status epilepticus. In a hospital setup, intravenous diazepam is commonly used for control of acute seizures, but it requires prompt establishment of an intravenous line and has the disadvantage of being a respiratory depressant [12]. Rectal diazepam is another alternative route, but is not always reliable owing to its variable bioavailability and wide range of serum

References (18)

There are more references available in the full text version of this article.

Cited by (129)

  • Use of new intranasal benzodiazepines at a typical adult epilepsy center

    2022, Epilepsy and Behavior
    Citation Excerpt :

    Furthermore, in the pediatric population it must be taken into consideration that intranasal diazepam is approved for use in patients 6 years of age and older, while intranasal midazolam is approved for 12 years of age and older. A few studies have compared intranasal midazolam versus rectal diazepam for at home treatment of ARS [10–12]. Holsti et al. [10] showed that there was no detectable difference in efficacy between the two, but the data suggested that there may be a trend toward faster seizure control in the intranasal midazolam group.

  • Dravet Syndrome: A Review of Current Management

    2020, Pediatric Neurology
    Citation Excerpt :

    Peak maximal plasma concentrations are typically reached within 0.5 hours.95 Comparator studies between rectal diazepam and alternative delivery routes are logistically complicated, but prospective studies provide some evidence of at least comparable efficacy.91,102,103 Somnolence is an adverse event common to all modes of delivery.90-101

  • Intranasal delivery of antiseizure drugs

    2020, Drug Delivery Devices and Therapeutic Systems
View all citing articles on Scopus
View full text