Status:
COMPLETED
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Primary Children's Hospital
Conditions:
Seizures
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
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...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00326612
Start Date
June 1 2006
End Date
December 1 2008
Last Update
October 26 2011
Active Locations (1)
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1
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113