Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00326612|
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : October 26, 2011
Last Update Posted : October 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Seizures||Drug: Midazolam Drug: Diazepam||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||358 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy|
|Study Start Date :||June 2006|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
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
- Length of Seizure After Study Medication Administration [ Time Frame: 24 hours ]Length of seizure.
- Respiratory Depression Requiring Intubation [ Time Frame: 24 hours ]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 ]
- 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 ]
- Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. [ Time Frame: 24 hours ]
- Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication [ Time Frame: 12 hours ]
- Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. [ Time Frame: 24 hours ]Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|