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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Seizures |
| Interventions: |
Drug: Midazolam Drug: Diazepam |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruited from a pediatric Neurology clinic. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Intranasal Midazolam | 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes |
| Rectal Diazepam | 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes |
| Intranasal Midazolam | Rectal Diazepam | |
|---|---|---|
| STARTED | 179 | 179 |
| COMPLETED | 50 | 42 |
| NOT COMPLETED | 129 | 137 |
| They did not have a seizure requiring tx | 129 | 137 |
Baseline Characteristics
| Description | |
|---|---|
| Intranasal Midazolam | 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes |
| Rectal Diazepam | 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes |
| Intranasal Midazolam | Rectal Diazepam | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
50 | 42 | 92 |
|
Age
[units: participants] |
|||
| <=18 years | 50 | 42 | 92 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
6.8 ± 5.0 | 7.3 ± 4.5 | 7.0 ± 4.8 |
|
Gender
[units: participants] |
|||
| Female | 26 | 20 | 46 |
| Male | 24 | 22 | 46 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 50 | 42 | 92 |
Outcome Measures
| 1. Primary: | Length of Seizure After Study Medication Administration [ Time Frame: 24 hours ] |
| 2. Secondary: | Respiratory Depression Requiring Intubation [ Time Frame: 24 hours ] |
| 3. Secondary: | Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours [ Time Frame: 24 hours ] |
| 4. 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 ] |
| 5. Secondary: | Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. [ Time Frame: 24 hours ] |
| 6. Secondary: | Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication [ Time Frame: 12 hours ] |
| 7. Secondary: | Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. [ Time Frame: 24 hours ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Maija Holsti, 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 |