Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326612
Status:
COMPLETED
Last Update Posted:
2011-10-26
First Post:
2006-05-15
Brief Title:
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parentsguardians 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 parentsguardians 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 parentsguardians will be contacted by phone every two months and questioned at clinic visits to audit compliance of reporting of seizureshospitalizations 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 Procedures Parentsguardians 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 parentsguardians 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 parentsguardians will be contacted by phone every two months and questioned at clinic visits to audit compliance of reporting of seizureshospitalizations 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None