CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 358 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Midazolam 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00326612
NCT00326612Phase 2Completed
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Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy

University of Utah·interventional·Posted May 17, 2006·Updated Oct 26, 2011

In Brief

A Phase 2 clinical trial evaluating Midazolam and Diazepam for Seizures. Completed, enrolled 358 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizures
CountriesUnited States
CollaboratorsPrimary Children's Hospital

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.1 years ago

Interventions

Midazolamdrug

Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.

Diazepamdrug

Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.