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Enteral Lorazepam as a weaning startegy in Refractory status epilepticus

Enteral lorazepam as a weaning strategy for midazolam responsive refractory status epilepticus : an open label Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056641
Enrollment
50
Registered
2023-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: G02- Meningitis in other infectious andparasitic diseases classified elsewhere

Interventions

Intervention1: enteral lorazepam: In all patients whose seizures will be responding to midazolam, the weaning of midazolam will be attempted for the first time 24 hours after the clinical and electrog

Sponsors

Manas Ranjan Sahoo
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1month to 14 year children with frequent seizures evolving into refractory status epilepticus

Exclusion criteria

Exclusion criteria: Conditions like GI bleeding where enteral lorazepam cannot be given 2. Refractory status epilepticus who have failed coma induction with midazolam, requiring iv anesthetics other than midazolam

Design outcomes

Primary

MeasureTime frame
Duration in days to taper midazolam after starting enteral lorazepam compared to conventional weaning by midazolam aloneTimepoint: 24hrs,36hrs,48hrs,72 hrs

Secondary

MeasureTime frame
No. days with refractory status epilepticus before starting enteral lorazepam 2.Dose of midazolam infusion when lorazepam was started (mg/kg/ minute) 3.Dose of enteral lorazepam at initiation (mg/kg/d) Timepoint: 2years

Countries

India

Contacts

Public ContactManas Ranjan Sahoo

AIIMS Raipur

drmrsahoo@gmail.com07893230151

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026