Phase 2
Completed N=358
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Seizures
Source: ClinicalTrials.gov NCT00326612 ↗
Enrolled (actual)
358
Serious AEs
1.1%
Results posted
Oct 2011
Primary outcomePrimary: Length of Seizure After Study Medication Administration — 3.0; 4.3 Minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Seizure After Study Medication Administration |
3.0; 4.3 | — |
| SECONDARY Respiratory Depression Requiring Intubation |
1; 0 | — |
| SECONDARY Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours |
5; 5 | — |
| SECONDARY Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication. |
21; 17 | — |
| SECONDARY Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication. |
4; 3 | — |
| SECONDARY Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication |
1; 1 | — |
| SECONDARY Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department. |
3; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00326612). 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. Informational only — not medical advice.