Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy|
- Length of Seizure After Study Medication Administration [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Length of seizure.
- Respiratory Depression Requiring Intubation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Respiratory depression was defined as intubation at Emergency Department discharge.
- Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.
|Study Start Date:||June 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Intranasal Midazolam 0.2mg/kg
GIve once for seizure longer than 5 minutes
Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
Other Name: Diastat
Active Comparator: Rectal Diazepam 0.3-0.5 mg/kg
Given once for seizure longer than 5 minutes
Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
Other Name: Versed
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326612
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84113|
|Principal Investigator:||Maija Holsti, MD, MPH||University of Utah|
|Study Chair:||Francis Filloux, MD||University of Utah|
|Study Chair:||Jeff Schunk, MD||University of Utah|