Clinical trial NCT00326612
Conditions: Seizures
Keywords: Seizures
Sponsor: University of Utah
Start date: 2006-06-01; Completion date: 2008-12-01
Enrollment: 358 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: GIve once for seizure longer than 5 minutes arm 2: Given once for seizure longer than 5 minutes
Interventions: intervention 1: Midazolam intervention 2: Diazepam
Intervention descriptions: intervention 1: Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes. intervention 2: Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.

Protocol documents: