Trial · NCT00809146
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
NCT00809146, Phase 3, Completed, Robert Silbergleit; results first posted 2012-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications. Trials, record NCT00809146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00809146
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
- NCT number
- NCT00809146
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,023 participants, actual
- Lead sponsor
- Robert Silbergleit
- Conditions
- Status Epilepticus
- Interventions
- Intramuscular route of active treatment, Intravenous route of active treatment
- First posted
- 2008-12-17
- Last updated
- 2016-06-17
- Results first posted
- 2012-04-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given | Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes). | The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing. |
| Secondary | Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival | anytime before 30 minutes after ED arrival | Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation. |
| Secondary | Number of Subjects Hospitalized | at ED disposition on day of enrollment | Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. |
| Secondary | Number of Subjects Admitted to an Intensive Care Unit (ICU) | at time of disposition on day of enrollment | Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. |
| Secondary | Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival | within 12 hours after ED arrival | Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival. |
| Secondary | Number of Subjects With Hypotension | participants were followed for the duration of hospital stay, an average of 6 days | Acute hypotension is defined as a systolic blood pressure of \< 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor. |
| Secondary | Number of Subjects With IM Injection-site Complications | participants were followed for the duration of hospital stay, an average of 6 days | IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems. |
| Secondary | Number of Subjects With IV Injection-site Complications | participants were followed for the duration of hospital stay, an average of 6 days | IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care. |
| Secondary | Length of Intensive Care Unit (ICU) Stay in Days | participants were followed for the duration of hospital stay, an average of 6 days | Continuous days of initial ICU stay from time of admission |
| Secondary | Length of Hospital Stay in Days | participants were followed for the duration of hospital stay, an average of 6 days | Continuous acute care inpatient hospital days from day of admission until discharge |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given | Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes). | participants | NUMBER | |
| SECONDARY | Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival | anytime before 30 minutes after ED arrival | participants | NUMBER | |
| SECONDARY | Number of Subjects Hospitalized | at ED disposition on day of enrollment | participants | NUMBER | |
| SECONDARY | Number of Subjects Admitted to an Intensive Care Unit (ICU) | at time of disposition on day of enrollment | participants | NUMBER | |
| SECONDARY | Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival | within 12 hours after ED arrival | participants | NUMBER | |
| SECONDARY | Number of Subjects With Hypotension | participants were followed for the duration of hospital stay, an average of 6 days | participants | NUMBER | |
| SECONDARY | Number of Subjects With IM Injection-site Complications | participants were followed for the duration of hospital stay, an average of 6 days | participants | NUMBER | |
| SECONDARY | Number of Subjects With IV Injection-site Complications | participants were followed for the duration of hospital stay, an average of 6 days | participants | NUMBER | |
| SECONDARY | Length of Intensive Care Unit (ICU) Stay in Days | participants were followed for the duration of hospital stay, an average of 6 days | All participants with ICU length of stay data | days | MEAN |
| SECONDARY | Length of Hospital Stay in Days | participants were followed for the duration of hospital stay, an average of 6 days | All subjects with hospital length of stay data | days | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given | IM Midazolam | 329 | participants | ||
| Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given | IV Lorazepam | 282 | participants | ||
| Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival | IM Midazolam | 63 | participants | ||
| Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival | IV Lorazepam | 64 | participants | ||
| Number of Subjects Hospitalized | IM Midazolam | 258 | participants | ||
| Number of Subjects Hospitalized | IV Lorazepam | 292 | participants | ||
| Number of Subjects Admitted to an Intensive Care Unit (ICU) | IM Midazolam | 128 | participants | ||
| Number of Subjects Admitted to an Intensive Care Unit (ICU) | IV Lorazepam | 161 | participants | ||
| Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival | IM Midazolam | 51 | participants | ||
| Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival | IV Lorazepam | 47 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intramuscular (IM) Anticonvulsant | 448 | |
| Overall Study | STARTED | Intravenous (IV) Anticonvulsant | 445 | |
| Overall Study | COMPLETED | Intramuscular (IM) Anticonvulsant | 448 | |
| Overall Study | COMPLETED | Intravenous (IV) Anticonvulsant | 445 | |
| Overall Study | NOT COMPLETED | Intramuscular (IM) Anticonvulsant | 0 | |
| Overall Study | NOT COMPLETED | Intravenous (IV) Anticonvulsant | 0 |
Source ClinicalTrials.gov
Adverse events106
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 |
|---|---|---|---|---|---|---|
| other | Convulsion | Nervous system disorders | IM Midazolam | 45 | 514 | |
| other | Convulsion | Nervous system disorders | IV Lorazepam | 38 | 509 | |
| other | Mental status changes | Nervous system disorders | IM Midazolam | 20 | 514 | |
| other | Mental status changes | Nervous system disorders | IV Lorazepam | 20 | 509 | |
| other | Vomiting/Nausea | Gastrointestinal disorders | IM Midazolam | 15 | 514 | |
| other | Vomiting/Nausea | Gastrointestinal disorders | IV Lorazepam | 23 | 509 | |
| other | Pyrexia | General disorders | IM Midazolam | 23 | 514 | |
| other | Pyrexia | General disorders | IV Lorazepam | 14 | 509 | |
| serious | Depressed level of consciousness | Nervous system disorders | IM Midazolam | 49 | 514 | |
| serious | Depressed level of consciousness | Nervous system disorders | IV Lorazepam | 45 | 509 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IM Midazolam | ||
| Total, all-cause mortality | IV Lorazepam | ||
| Total, other adverse events | IM Midazolam | 103 | 514 |
| Total, other adverse events | IV Lorazepam | 95 | 509 |
| Total, serious adverse events | IM Midazolam | 137 | 514 |
| Total, serious adverse events | IV Lorazepam | 156 | 509 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS056975 | Neurologic Emergencies Treatment Trials Network: Clinical Coordinating Center | BARSAN, WILLIAM G | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2006 to 2015 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IM Midazolam vs IV Lorazepam: Number of Subjects Admitted to an Intensive Care Unit (ICU) | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects With Hypotension | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects Hospitalized | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects With IM Injection-site Complications | Trial comparisons |
| IM Midazolam vs IV Lorazepam: Number of Subjects With IV Injection-site Complications | Trial comparisons |
| IM Midazolam vs IV Lorazepam: 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/NCT00809146
GET https://conductscience.org/api/trials/v1/NCT00809146/events?page=2