search
Back to results

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

Primary Purpose

Seizures

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
IV diazepam
I/N Midazolam
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Intravenous Diazepam

    Intranasal Midazolam

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Time taken for seizures to be controlled
    Intranasal midazolam will take less time for cessation of seizure than intravenous diazepam

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2021
    Last Updated
    May 12, 2021
    Sponsor
    Shaheed Zulfiqar Ali Bhutto Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04885075
    Brief Title
    Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam for Control of Seizures in Children
    Official Title
    A Randomized Controlled Trial Comparing the Efficacy of Intranasal Midazolam and Conventional Treatment With Intravenous Diazepam for Control of Seizures in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 30, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2021 (Anticipated)
    Study Completion Date
    November 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaheed Zulfiqar Ali Bhutto Medical University

    4. Oversight

    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

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seizures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous Diazepam
    Arm Type
    Other
    Arm Description
    Intravenous diazepam (0.2mg/kg/dose) single dose stat
    Arm Title
    Intranasal Midazolam
    Arm Type
    Other
    Arm Description
    Intranasal midazolam (0.2mg/kg/dose) single dose stat
    Intervention Type
    Drug
    Intervention Name(s)
    IV diazepam
    Other Intervention Name(s)
    valium
    Intervention Description
    inj.diazepam 0.2mg/kg/dose stat
    Intervention Type
    Drug
    Intervention Name(s)
    I/N Midazolam
    Other Intervention Name(s)
    dormicum
    Intervention Description
    intranasal midazolam 0.2mg/kg/dose stat
    Primary Outcome Measure Information:
    Title
    Time taken for seizures to be controlled
    Description
    Intranasal midazolam will take less time for cessation of seizure than intravenous diazepam
    Time Frame
    From administration of drug to the cessation of seizures up to 10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zunash fateh, mbbs
    Phone
    03344360704
    Email
    zunash.ammar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    nighat haider, mbbs,fcps
    Phone
    03361422244
    Email
    nighathaider@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nighat haider, mbbs,fcps
    Organizational Affiliation
    Shaheed Zulfiqar Ali Bhutto Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs