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Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

NCT00326612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2011-10-26

Study results available
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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.

Conditions

Interventions

DRUG

Midazolam

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

DRUG

Diazepam

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

Sponsors & Collaborators

Principal Investigators

  • Maija Holsti, MD, MPH · University of Utah

  • Francis Filloux, MD · University of Utah

  • Jeff Schunk, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00326612 on ClinicalTrials.gov