Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

Completed · Phase 2

Conditions studied: Seizures

In brief

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.

Key facts

Study ID

NCT00326612

Run by

University of Utah

People needed

358

Starts

2006-06-01

Expected to finish

2008-12-01

Last updated by the study team

2011-10-26

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Primary Children's Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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