Clinical trial NCT00326612: Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Official title: Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seizures
Keywords: Seizures
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Primary Children's Hospital
First posted: 2006-05-17
Enrollment: 358
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Children seventeen years and under will be identified through a Pediatric Neurology clinic at Primary Children's Medical Center,
* Known seizure disorder, AND
* Either have or will be prescribed a rescue anti-epileptic (rectal diazepam, or Diastat) for home use by their neurologist.

Exclusion Criteria:

* The neurologist does not prescribe a rescue medication for home use,
* 18 years of age or older,
* They have absence seizures, OR
* They have been prescribed lorazepam for home use for seizure activity.

Primary outcomes:
measure: Length of Seizure After Study Medication Administration
timeFrame: 24 hours
Secondary outcomes:
measure: Respiratory Depression Requiring Intubation
timeFrame: 24 hours
measure: Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours
timeFrame: 24 hours
measure: Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.
timeFrame: 24 hours
measure: Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.
timeFrame: 24 hours
measure: Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication
timeFrame: 12 hours
measure: Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Maija Holsti, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Francis Filloux, MD
role: STUDY_CHAIR
affiliation: University of Utah
name: Jeff Schunk, MD
role: STUDY_CHAIR
References:
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