Trial · NCT00326612
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
NCT00326612, Phase 2, Completed, University of Utah; results first posted 2011-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures. Trials, record NCT00326612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326612
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
- NCT number
- NCT00326612
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 358 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Seizures
- Interventions
- Midazolam, Diazepam
- First posted
- 2006-05-17
- Last updated
- 2011-10-26
- Results first posted
- 2011-10-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Seizure After Study Medication Administration | 24 hours | Length of seizure. |
| Secondary | Respiratory Depression Requiring Intubation | 24 hours | Respiratory depression was defined as intubation at Emergency Department discharge. |
| Secondary | Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | 24 hours | |
| Secondary | Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | 24 hours | |
| Secondary | Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | 24 hours | |
| Secondary | Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication | 12 hours | |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Seizure After Study Medication Administration | 24 hours | Analysis was per protocol | Minutes | MEDIAN |
| SECONDARY | Respiratory Depression Requiring Intubation | 24 hours | Analysis was per protocol | participants | NUMBER |
| SECONDARY | Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | 24 hours | participants | NUMBER | |
| SECONDARY | Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | 24 hours | participants | NUMBER | |
| SECONDARY | Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | 24 hours | participants | NUMBER | |
| SECONDARY | Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication | 12 hours | participants | NUMBER | |
| SECONDARY | Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. | 24 hours | Analysis was per protocol | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Seizure After Study Medication Administration | Intranasal Midazolam | 3.0 | Inter-Quartile Range 15.7 | Minutes | |
| Length of Seizure After Study Medication Administration | Rectal Diazepam | 4.3 | Inter-Quartile Range 11.3 | Minutes | |
| Respiratory Depression Requiring Intubation | Intranasal Midazolam | 1 | 0.0 to 8.3 | participants | |
| Respiratory Depression Requiring Intubation | Rectal Diazepam | 0 | 0 to 5 | participants | |
| Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | Intranasal Midazolam | 5 | 2 to 12 | participants | |
| Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | Rectal Diazepam | 5 | 4 to 15 | participants | |
| Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | Intranasal Midazolam | 21 | participants | ||
| Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | Rectal Diazepam | 17 | participants | ||
| Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | Intranasal Midazolam | 4 | 1 to 10 | participants | |
| Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | Rectal Diazepam | 3 | 1 to 8 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intranasal Midazolam | 179 | |
| Overall Study | STARTED | Rectal Diazepam | 179 | |
| Overall Study | COMPLETED | Intranasal Midazolam | 50 | |
| Overall Study | COMPLETED | Rectal Diazepam | 42 | |
| Overall Study | NOT COMPLETED | Intranasal Midazolam | 129 | |
| Overall Study | NOT COMPLETED | Rectal Diazepam | 137 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Intubation | Respiratory, thoracic and mediastinal disorders | Intranasal Midazolam | 1 | 50 | 1 |
| serious | Intubation | Respiratory, thoracic and mediastinal disorders | Rectal Diazepam | 0 | 42 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Midazolam | ||
| Total, all-cause mortality | Rectal Diazepam | ||
| Total, other adverse events | Intranasal Midazolam | 0 | 50 |
| Total, other adverse events | Rectal Diazepam | 0 | 42 |
| Total, serious adverse events | Intranasal Midazolam | 1 | 50 |
| Total, serious adverse events | Rectal Diazepam | 0 | 42 |
Source ClinicalTrials.gov
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intranasal Midazolam vs Rectal Diazepam: Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. | Trial comparisons |
| Intranasal Midazolam vs Rectal Diazepam: Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication | Trial comparisons |
| Intranasal Midazolam vs Rectal Diazepam: Respiratory Depression Requiring Intubation | Trial comparisons |
| Intranasal Midazolam vs Rectal Diazepam: Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. | Trial comparisons |
| Intranasal Midazolam vs Rectal Diazepam: Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. | Trial comparisons |
| Intranasal Midazolam vs Rectal Diazepam: Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours | Trial comparisons |
| Intranasal Midazolam vs Rectal Diazepam: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00326612
GET https://conductscience.org/api/trials/v1/NCT00326612/papers?page=2