Phase 3
N=893
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
Status Epilepticus
Bottom Line
View on ClinicalTrials.gov: NCT00809146 ↗Enrolled (actual)
893
Serious AEs
28.6%
Results posted
Apr 2012
Primary outcome: Primary: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given — 329; 282 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intramuscular route of active treatment (Drug); Intravenous route of active treatment (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Robert Silbergleit
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given |
329; 282 | <0.001 sig |
| SECONDARY Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival |
63; 64 | — |
| SECONDARY Number of Subjects Hospitalized |
258; 292 | — |
| SECONDARY Number of Subjects Admitted to an Intensive Care Unit (ICU) |
128; 161 | — |
| SECONDARY Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival |
51; 47 | — |
| SECONDARY Number of Subjects With Hypotension |
12; 13 | — |
| SECONDARY Number of Subjects With IM Injection-site Complications |
4; 2 | — |
| SECONDARY Number of Subjects With IV Injection-site Complications |
0; 3 | — |
| SECONDARY Length of Intensive Care Unit (ICU) Stay in Days |
5.7; 4.1 | 0.09 |
| SECONDARY Length of Hospital Stay in Days |
6.7; 5.5 | 0.11 |
Summary
The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
Eligibility Criteria
Inclusion Criteria
- Paramedics or reliable witnesses verify 5 minutes of either continuous seizure activity or of repeated convulsive seizure activity where the patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.
- Patient is still seizing at the time of paramedic treatment with study medications.
- Estimated weight equal to or greater than 13 kg.
- Subject to be transported to a RAMPART participating hospital.
Exclusion Criteria
- Major trauma as the precipitant of the seizure
- Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)
- Known allergy to midazolam or lorazepam
- Cardiac arrest or heart rate (HR) <40 beats per minute
- Sensitivity to benzodiazepines
- Medical alert tag marked with "RAMPART declined"
- Prior treatment of this seizure with diazepam autoinjector as part of another study
- Known pregnancy
- Prisoners
Data sourced from ClinicalTrials.gov (NCT00809146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.