Effect of midazolam through nasal versus intravenous route in controlling seizures in children.
- Conditions
- Disorder of central nervous system, unspecified,
- Registration Number
- CTRI/2024/01/061644
- Lead Sponsor
- Government medical college and hospital, Chandigarh
- Brief Summary
A seizure is a neurological emergency in children that results from an uncontrolled or
synchronous electrical disturbance in the brain. These disturbances can cause a variety of
brief signs and symptoms, such as altered perception of sensations, confusion, uncontrollable
jerking movements, and loss of consciousness.
Delayed treatment has been associated with a higher risk of death, longer seizure duration,
and continuous administration of medication to stop seizures, all of which can result in
morphological cortical brain damage and might cause irreversible neuronal injury due to
excitotoxicity. Recent guidelines for managing seizures have placed a strong emphasis on
necessity to commence drug treatment as early as feasible to avoid complications. Prompt
and efficient treatment is necessary for children undergoing acute seizures to terminate
seizure activity and avert the development of prolonged seizures and status epilepticus. IV
administration of the drugs could be the best route to achieve this and is most used in routine
emergency practices. But in children with active seizures, gaining IV access can be
challenging especially in primary health centers and this might lead to significant delay in
seizure cessation. Additionally, the majority of seizure emergencies arise outside of medical
facilities, underscoring the importance of medical interventions that caregivers can swiftly
and securely administer. So other routes that are minimally invasive with similar efficacy like
buccal, intranasal, or rectal routes need to be considered.
Benzodiazepines are the first-line drugs for acute seizure control in children. Midazolam, a
short-acting benzodiazepine, being water and lipid soluble (physiological pH),
crosses nasal mucosa and blood-brain barrier causing a rapid rise in plasma and CSF
concentrations. The administration of Buccal Midazolam is frequently impeded by
symptoms such as jaw clenching, excessive salivation, or involuntary swallowing. Following
nasal administration, midazolam has higher bioavailability, bypassing hepatic clearance.
Intranasal midazolam offers an excellent alternative especially for an out-of-hospital setting
and is socially acceptable unlike rectal midazolam. Approximately six minutes after
intranasal administration of 0.2 mg/kg, the plasma concentration of midazolam
reaches 100 ng/ml. However, IV midazolam is used in daily practices in our emergency
setting for children presenting with seizures which require the prompt establishment of
intravenous lines whereas IN formulations of midazolam, being non-invasive provide an
alternative strategy in this direction, and numerous studies were done to assess its anti-seizure
efficacy which have observed favorable outcomes, especially taking into account the
time required to establish IV line and patient considerations including patient positioning and
the need for privacy when employing the rectal mode of administration; IN midazolam may
prevent delay in commencing treatment.
Hence a comparison of the two different routes of administration is not possible unless RCT
is done wherein both routes are used in supervised emergency conditions. Compared to the
IV route, the use of IN midazolam is easier for parents and is more accessible. This
medication can be administered not only in medical centers but also at home, provided that
the parents of children with acute seizures receive appropriate instructions. The utilization of
intranasal midazolam for controlling acute seizures may lead to better patient care and
increased safety for healthcare professionals. There are reports in the literature regarding the
comparison of IN midazolam with other benzodiazepines used intravenously or other
routes, however, no data is available regarding the comparison of IN vs IV midazolam.
Therefore,“the purpose of this clinical trial is to assess the effectiveness of intranasal
midazolam in comparison to intravenous administration for treating acute seizures in
paediatric patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
All children between the ages of 1 month and 18 years presenting with acute seizures for at least 5 minutes duration in pediatric emergency and in patient department of GMCH 32, Chandigarh.
- Non consenting parents 2) Children <5kg weight 3) Children with upper respiratory tract infections 4) Children who had received anticonvulsants within 1 hour before admission 5) Children with severe cardiorespiratory decompensation 6) Children with CSF rhinorrhea 7) Known allergy to benzodiazepines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seizure cessation Interval between arrival of patients at the hospital with active seizures/ witnessed seizures more than 5 minutes and the control of seizures
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions among the patients receiving intranasal & intravenous midazolam. 30 minutes
Trial Locations
- Locations (1)
Government medical college and hospital, Chandigarh.
🇮🇳Chandigarh, CHANDIGARH, India
Government medical college and hospital, Chandigarh.🇮🇳Chandigarh, CHANDIGARH, IndiaDrSherlin JeberzhiahPPrincipal investigator9677683551sherlinjeberzhiahp@gmail.com