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Comparing midazolam to stop seizures when given through muscle versus when given through nose.

Randomized controlled trial comparing efficacy of intranasal versus intramuscular midazolam in terminating seizure during pre surgical epilepsy VEEG monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016023
Enrollment
170
Registered
2018-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system Health Condition 2: G402- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

Interventions

Intervention1: Intranasal Midazolam: Total dose of 0.2 mg/kg administered equally in each nostril in children. In adults 5 mg in each nostril to a total dose of 10 mg Stat at each prolonged seizure Co

Sponsors

AIIMS
Lead Sponsor
Prof Manjari tripathi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All age groups patients with drug refractory epilepsy admitted in epilepsy monitoring unit for Video EEG , AIIMS New Delhi

Exclusion criteria

Exclusion criteria: 1.Patients with chronic kidney and liver disease 2.Patients with shock, hypotension and known respiratory illness. 3. Acute precipitant of seizure was major trauma, hypoglycemia, cardiac arrest or heart rate less than 40 beats per minute. 4.Pregnant patients 5.Patients known allergic to midazolam. 6. Patients with known Coagulopathy

Design outcomes

Primary

MeasureTime frame
Mean time in minutes/seconds required to terminate clinical and electrical seizure activity as documented by video EEG after drug administrationTimepoint: Patients having focal seizures for duration more than 5 minutes or generalized seizures more than 2 minutes will be given intranasal or intravenous midazolam as per randomization in following mentioned dose—

Secondary

MeasureTime frame
1.Serious adverse events related to midazolam. 2. Local side effects related to drug route . 3. Any injury related to seizuresTimepoint: â?¢ Patients having focal seizures for duration more than 5 minutes or generalized seizures more than 2 minutes will be given intranasal or intravenous midazolam as per randomization in following mentioned dose—

Countries

India

Contacts

Public ContactRAJA GULFAM SHAIKH

AIIMS, New Delhi

manjaritaiims@gmail.com9868398269

Outcome results

None listed

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