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| Sponsors and Collaborators: |
University of Utah Primary Children's Medical Center Foundation |
|---|---|
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00326612 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy |
| Estimated Enrollment: | 200 |
| 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 |
|---|---|
| 1: Experimental |
Drug: Midazolam
Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
|
| 2: Active Comparator |
Drug: Diazepam
Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| 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
| Responsible Party: | Division of Pediatric Emergency Medicine, Dept. of Pediatrics ( Maija Holsti, MD, MPH ) |
| Study ID Numbers: | 15275 |
| Study First Received: | May 15, 2006 |
| Last Updated: | December 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00326612 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Seizures |
|
Anesthetics, Intravenous Neurotransmitter Agents Tranquilizing Agents Diazepam Seizures Psychotropic Drugs Adjuvants, Immunologic Central Nervous System Depressants Central Nervous System Diseases Anesthetics Antiemetics |
Brain Diseases Midazolam Signs and Symptoms Anesthetics, General Epilepsy Muscle Relaxants, Central Hypnotics and Sedatives Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Anticonvulsants |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Antiemetics Neuromuscular Agents Brain Diseases Signs and Symptoms Therapeutic Uses Muscle Relaxants, Central Hypnotics and Sedatives Anesthetics, Intravenous Tranquilizing Agents |
Diazepam Nervous System Diseases Seizures Gastrointestinal Agents Central Nervous System Diseases Central Nervous System Depressants Midazolam Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Epilepsy Autonomic Agents GABA Agents Neurologic Manifestations Anti-Anxiety Agents |
