Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will conduct a randomized controlled trial comparing the use of nasal
      midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute
      seizure activity in children under the age of 18 years with epilepsy in the community
      setting. The primary hypothesis is that nasal midazolam will be more effective and have
      shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses
      are that patients treated with nasal midazolam will have fewer respiratory complications,
      emergency department visits, and admissions.
    

Detailed description: 
      Study Design: This is a prospective randomized controlled study.

      Study Procedures: Parents/guardians will be provided with a stopwatch to help record seizure
      times on the "Parent Form". All parents of children who have a seizure lasting longer than
      five minutes will be randomized to treat their seizure with the study medication (either
      rectal diazepam or nasal midazolam). If a parent treats a child with a study medication for
      seizure activity they are required to call "911". Families will be instructed to only give
      one dose of the study medication. If the seizure persists, EMS may give a second medication
      and transport the patient to the ED as per their established protocol. All parents/guardians
      who participate in this study will be asked to fill out a "Pre-study Form" (to be filled out
      during enrollment into the study) and a "Parent Form" for every seizure that is treated with
      the study medication. They will be given a stamped returned envelope to return the
      questionnaire. Once the study medication is used once, they will be done with the study. Any
      further need of home rescue medications to treat acute seizure activity will be coordinated
      by their neurologist. If questions arise, a study coordinator will be available by phone. In
      addition, parents/guardians will be contacted by phone every two months and questioned at
      clinic visits to audit compliance of reporting of seizures/hospitalizations, adverse events
      and answer any questions that arise. The study packet also instructs all families to call the
      study coordinator immediately if any expected or unexpected complication occurs. The study
      coordinator will be called on all ED visits and hospitalizations. We will then collect and
      analyze adverse events to compare them between the two groups. Any ER visit or
      hospitalization will be considered an adverse event and will be analyzed for its relationship
      to the seizure or medication. All adverse events will be reported to the IRB. See Table 1 for
      doses for the two study medications.
    

Intervention name(s): Midazolam; Diazepam
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.; Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
Other intervention name(s): Diastat; Versed
Intervention MeSH terms: Midazolam; Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures