Seizures
Conditions
Keywords
Seizures
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.
Interventions
DRUGMidazolam
Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes.
DRUGDiazepam
Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.
Sponsors
Primary Children's Hospital
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Seizure After Study Medication Administration | 24 hours | Length of seizure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 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. | 24 hours | — |
| Respiratory Depression Requiring Intubation | 24 hours | Respiratory depression was defined as intubation at Emergency Department discharge. |
| Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication | 12 hours | — |
| Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. | 24 hours | Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department. |
| Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | 24 hours | — |
Countries
United States
Participant flow
Recruitment details
Recruited from a pediatric Neurology clinic.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Midazolam 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes | 50 |
| Rectal Diazepam 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes | 42 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | They did not have a seizure requiring tx | 129 | 137 |
Baseline characteristics
| Characteristic | Rectal Diazepam | Intranasal Midazolam | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 42 Participants | 50 Participants | 92 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 7.3 years STANDARD_DEVIATION 4.5 | 6.8 years STANDARD_DEVIATION 5 | 7.0 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment United States | 42 participants | 50 participants | 92 participants |
| Sex: Female, Male Female | 20 Participants | 26 Participants | 46 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 42 |
| serious Total, serious adverse events | 1 / 50 | 0 / 42 |
Outcome results
Primary
Length of Seizure After Study Medication Administration
Length of seizure.
Time frame: 24 hours
Population: Analysis was per protocol
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intranasal Midazolam | Length of Seizure After Study Medication Administration | 3.0 Minutes | Inter-Quartile Range 15.7 |
| Rectal Diazepam | Length of Seizure After Study Medication Administration | 4.3 Minutes | Inter-Quartile Range 11.3 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Midazolam | Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | 21 participants |
| Rectal Diazepam | Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | 17 participants |
95% CI: [0.4, 2.7]
Secondary
Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Midazolam | Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | 4 participants |
| Rectal Diazepam | Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | 3 participants |
95% CI: [0.2, 8.2]
Secondary
Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Midazolam | Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication | 1 participants |
| Rectal Diazepam | Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication | 1 participants |
95% CI: [0, 67.3]
Secondary
Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Midazolam | Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | 5 participants |
| Rectal Diazepam | Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | 5 participants |
95% CI: [0.2, 3.9]
Secondary
Respiratory Depression Requiring Intubation
Respiratory depression was defined as intubation at Emergency Department discharge.
Time frame: 24 hours
Population: Analysis was per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Midazolam | Respiratory Depression Requiring Intubation | 1 participants |
| Rectal Diazepam | Respiratory Depression Requiring Intubation | 0 participants |
Secondary
Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.
Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.
Time frame: 24 hours
Population: Analysis was per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Midazolam | Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. | 3 participants |
| Rectal Diazepam | Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. | 1 participants |
95% CI: [0.2, 140.7]