Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Primary Children's Hospital
• Treatments: Diazepam; Midazolam

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.