Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam for Control of Seizures in Children
A Randomized Controlled Trial Comparing the Efficacy of Intranasal Midazolam and Conventional Treatment With Intravenous Diazepam for Control of Seizures in Children
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2021
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedStudy Start
First participant enrolled
May 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedMay 13, 2021
May 1, 2021
6 months
March 28, 2021
May 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time taken for seizures to be controlled
Intranasal midazolam will take less time for cessation of seizure than intravenous diazepam
From administration of drug to the cessation of seizures up to 10 minutes
Study Arms (2)
Intravenous Diazepam
OTHERIntravenous diazepam (0.2mg/kg/dose) single dose stat
Intranasal Midazolam
OTHERIntranasal midazolam (0.2mg/kg/dose) single dose stat
Interventions
Eligibility Criteria
You may qualify if:
- Children 1-10 years both male and female visiting/admitted in Children Hospital PIMS with acute episode of seizure (febrile or afebrile)
You may not qualify if:
- Children requiring emergency resuscitation
- Children with uncontrolled epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
nighat haider, mbbs,fcps
Shaheed Zulfiqar Ali Bhutto Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor of paediatrics
Study Record Dates
First Submitted
March 28, 2021
First Posted
May 13, 2021
Study Start
May 30, 2021
Primary Completion
November 30, 2021
Study Completion
November 30, 2021
Last Updated
May 13, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share