Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

September 19, 2011 updated by: Maija Holsti, University of Utah

Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 of children who have a seizure lasting longer than five minutes will be randomized to treat their seizure with the study medication (either rectal diazepam or nasal midazolam). If a parent treats a child with a study medication for seizure activity they are required to call "911". Families will be instructed to only give one dose of the study medication. If the seizure persists, EMS may give a second medication and transport the patient to the ED as per their established protocol. All parents/guardians who participate in this study will be asked to fill out a "Pre-study Form" (to be filled out during enrollment into the study) and a "Parent Form" for every seizure that is treated with the study medication. They will be given a stamped returned envelope to return the questionnaire. Once the study medication is used once, they will be done with the study. Any further need of home rescue medications to treat acute seizure activity will be coordinated by their neurologist. If questions arise, a study coordinator will be available by phone. In addition, parents/guardians will be contacted by phone every two months and questioned at clinic visits to audit compliance of reporting of seizures/hospitalizations, adverse events and answer any questions that arise. The study packet also instructs all families to call the study coordinator immediately if any expected or unexpected complication occurs. The study coordinator will be called on all ED visits and hospitalizations. We will then collect and analyze adverse events to compare them between the two groups. Any ER visit or hospitalization will be considered an adverse event and will be analyzed for its relationship to the seizure or medication. All adverse events will be reported to the IRB. See Table 1 for doses for the two study medications.

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intranasal Midazolam 0.2mg/kg
GIve once for seizure longer than 5 minutes
Drug: Midazolam
Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
Other Names:
  • Diastat
Active Comparator: Rectal Diazepam 0.3-0.5 mg/kg
Given once for seizure longer than 5 minutes
Drug: Diazepam
Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
Other Names:
  • Versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Seizure After Study Medication Administration
Time Frame: 24 hours
Length of seizure.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Depression Requiring Intubation
Time Frame: 24 hours
Respiratory depression was defined as intubation at Emergency Department discharge.
24 hours
Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours
Time Frame: 24 hours
24 hours
Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.
Time Frame: 24 hours
24 hours
Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.
Time Frame: 24 hours
24 hours
Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication
Time Frame: 12 hours
12 hours
Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.
Time Frame: 24 hours
Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Primary Children's Hospital

Investigators

  • Principal Investigator: Maija Holsti, MD, MPH, University of Utah
  • Study Chair: Francis Filloux, MD, University of Utah
  • Study Chair: Jeff Schunk, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

September 19, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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