Purpose To determine the efficacy of intranasal (IN) midazolam in the management of pediatric patients between 6 months and 16 years of age presenting with an active seizure. Our hypothesis is that IN midazolam is more effective in stopping seizure activity than rectal (PR) diazepam and can do so in a shorter period of time from the time of presentation to hospital.
Methods Inclusion criteria: (1) age between 6 months and 16 years old and (2) active seizure activity and duration of greater than 10 minutes. Exclusion criteria include (1) age less than 6 months old; (2) previous administration of any anti-epileptic medication for the presenting seizure episode; (3) spontaneous cessation of seizure; and (4) critical level of illness or injury, such that the following the study protocol would distract health professionals from providing other life-sustaining care. All children meeting the inclusion criteria will be treated in the same way. Each child will be assigned a package containing either an intravenous (IV) preparation of midazolam (which will be used IN) and a diazepam placebo, or midazolam placebo and PR preparation of diazepam. Both drug and placebo will be administered as contemporaneously as possible. After administration, patients will be monitored at regular intervals for 1 hour. Vital signs, time of seizure cessation, and any adverse events will be recorded. Treatment would be considered successful if seizures cease within 5 minutes of administration; successful but delayed if within 5 to 10 minutes; and failure if seizures persist beyond 10 minutes or recur.
Results This study is currently in the process of enrolling patients.
Implications for Practice Intranasal midazolam is a proven safe and effective means of managing acute seizures in children and may be a superior alternative to rectal diazepam for several reasons. It can provide more reliable serum concentrations and bioavailability, in addition to a simpler and less complicated route of administration. This would decrease time to seizure cessation and thus morbidity. In addition, the intranasal route provides a more palatable alternative for health care providers and parents who find rectal administration less acceptable because of the undignified nature of the procedure.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.