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Intranasal midazolam vs IV diazepam for pediatric seizures
NCT04885075Phase 4
Key facts
- Status
- Unknown
- Start
- May 2021
- Primary completion
- Nov 2021
- Sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Modality
- Small Molecules
- Drugs
- midazolam
- Conditions
- epilepsy
01
Overview
Phase 4, randomised, open-label trial of midazolam in epilepsy (2 arms), sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Primary endpoint: Time taken for seizures to be controlled at 10 minutes. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Intravenous Diazepam
Single dose of intravenous diazepam (0.2mg/kg/dose)
Intranasal Midazolam
Single dose of intranasal midazolam (0.2mg/kg/dose)
03
Who it enrols
Children 1-10 years with acute episode of seizure (febrile or afebrile), excluding those requiring emergency resuscitation or with uncontrolled epilepsy.
04
Endpoints
Primary
Time taken for seizures to be controlled
Secondary
Time required for gaining intravenous access
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