Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

This study has been completed.
Sponsor:
Collaborator:
Primary Children's Medical Center Foundation
Information provided by (Responsible Party):
Maija Holsti, University of Utah
ClinicalTrials.gov Identifier:
NCT00326612
First received: May 15, 2006
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Seizures
Drug: Midazolam
Drug: Diazepam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Length of Seizure After Study Medication Administration [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Length of seizure.


Secondary Outcome Measures:
  • Respiratory Depression Requiring Intubation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.


Enrollment: 358
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Versed

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326612

Locations
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Primary Children's Medical Center Foundation
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maija Holsti, Associate Professor Division of Pediatric Emergency Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT00326612     History of Changes
Other Study ID Numbers: 15275
Study First Received: May 15, 2006
Results First Received: March 10, 2011
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Utah:
Seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diazepam
Midazolam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents

ClinicalTrials.gov processed this record on April 17, 2014