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Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam for Control of Seizures in Children

Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04885075
Collaborator
(none)
60
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

After approval , study will be conducted at the Children Hospital PIMS, Islamabad. Children 1-12 years presenting/admitted with seizures will be enrolled in the study after taking informed consent from the parents. Children's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive single dose of intravenous diazepam (0.2mg/kg/dose)after passing cannula, while Group B (GB) will receive single dose of intranasal midazolam (0.2mg/kg/dose).Response to treatment will be assessed by recording the time required for termination of seizures in both gruops.the time required for gaining intravenous accessin Group A will be recorded as well. Data will be collected through a structured performa.

Condition or Disease Intervention/Treatment Phase
  • Drug: IV diazepam
  • Drug: I/N Midazolam
 Phase 4

Detailed Description

Benzodiazepines are the first line of drugs for cessation of acute seizures.benzodizepines can be given intravenous,orally,per rectal and intranasal.Conventional treatment of acute seizures is intravenous diazepam in most hospital settings which requires an IV access,which is not possible for parents to give at home.The main problem in an actively seizuring child is to reach the hospital and maintaining an intravenous line.Midazolam is a water soluble benzodiazepine which is widely used as an anxiolytic and anticonvulsant ,can be given through intravenously,intramuscularly, oral,buccal and nasal mucosa as well.it becomes lipid soluble at physiologic PH levels and reaches the CNS with a rapid onset and shorter duration of action.It is administered into nostril in a way that it comes into direct contact with nasal mucosa.It is given in a dose of 0.2mg\kg and within a few minutes its level in serum are comparable to the injectables levels.It is a safe,cheap,easy to use and effective alternative to diazepam for use at home as well as in hospital settings.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Comparing the Efficacy of Intranasal Midazolam and Conventional Treatment With Intravenous Diazepam for Control of Seizures in Children
Anticipated Study Start Date :
May 30, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Intravenous Diazepam

Intravenous diazepam (0.2mg/kg/dose) single dose stat

Drug: IV diazepam
inj.diazepam 0.2mg/kg/dose stat
Other Names:
  • valium

    		•
    Other: Intranasal Midazolam

    Intranasal midazolam (0.2mg/kg/dose) single dose stat

    Drug: I/N Midazolam
    intranasal midazolam 0.2mg/kg/dose stat
    Other Names:
  • dormicum

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time taken for seizures to be controlled [From administration of drug to the cessation of seizures up to 10 minutes]

      Intranasal midazolam will take less time for cessation of seizure than intravenous diazepam

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children 1-10 years both male and female visiting/admitted in Children Hospital PIMS with acute episode of seizure (febrile or afebrile)
    Exclusion Criteria:

    • Children requiring emergency resuscitation

    • Children with uncontrolled epilepsy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shaheed Zulfiqar Ali Bhutto Medical University

    Investigators

    • Principal Investigator: nighat haider, mbbs,fcps, Shaheed Zulfiqar Ali Bhutto Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Nighat Haider, assistant professor of paediatrics, Shaheed Zulfiqar Ali Bhutto Medical University
    ClinicalTrials.gov Identifier:
    NCT04885075
    Other Study ID Numbers:
    • No.F.1-1/2015/ERB/SZABMU/602
    First Posted:
    May 13, 2021
    Last Update Posted:
    May 13, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Seizures
    Midazolam
    Diazepam

    Study Results

    No Results Posted as of May 13, 2021