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Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

Primary Purpose

Seizures

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Midazolam
Diazepam
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring Seizures

Eligibility Criteria

1 Week - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Primary Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intranasal Midazolam 0.2mg/kg

Rectal Diazepam 0.3-0.5 mg/kg

Arm Description

GIve once for seizure longer than 5 minutes

Given once for seizure longer than 5 minutes

Outcomes

Primary Outcome Measures

Length of Seizure After Study Medication Administration
Length of seizure.

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2006
Last Updated
September 19, 2011
Sponsor
University of Utah
Collaborators
Primary Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00326612
Brief Title
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Official Title
Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Primary Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Midazolam 0.2mg/kg
Arm Type
Active Comparator
Arm Description
GIve once for seizure longer than 5 minutes
Arm Title
Rectal Diazepam 0.3-0.5 mg/kg
Arm Type
Active Comparator
Arm Description
Given once for seizure longer than 5 minutes
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Diastat
Intervention Description
Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
Intervention Type
Drug
Intervention Name(s)
Diazepam
Other Intervention Name(s)
Versed
Intervention Description
Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
Primary Outcome Measure Information:
Title
Length of Seizure After Study Medication Administration
Description
Length of seizure.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Respiratory Depression Requiring Intubation
Description
Respiratory depression was defined as intubation at Emergency Department discharge.
Time Frame
24 hours
Title
Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours
Time Frame
24 hours
Title
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
Title
Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.
Time Frame
24 hours
Title
Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication
Time Frame
12 hours
Title
Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.
Description
Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maija Holsti, MD, MPH
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Filloux, MD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeff Schunk, MD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
Facility Information:
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States

12. IPD Sharing Statement

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Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

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