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

NCT ID: NCT04885075

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2021-11-30

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.

Conditions

Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Diazepam

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

Group Type: OTHER

IV diazepam

Intervention Type: DRUG

inj.diazepam 0.2mg/kg/dose stat

Intranasal Midazolam

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

Group Type: OTHER

I/N Midazolam

Intervention Type: DRUG

intranasal midazolam 0.2mg/kg/dose stat

Interventions

IV diazepam

inj.diazepam 0.2mg/kg/dose stat

Intervention Type: DRUG

I/N Midazolam

intranasal midazolam 0.2mg/kg/dose stat

Intervention Type: DRUG

Other Intervention Names

valium; dormicum

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dr Nighat Haider

assistant professor of paediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nighat haider, mbbs,fcps

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University

Central Contacts

zunash fateh, mbbs

Role: CONTACT

zunash.ammar@gmail.com

03344360704

nighat haider, mbbs,fcps

Role: CONTACT

nighathaider@hotmail.com

03361422244

Other Identifiers

No.F.1-1/2015/ERB/SZABMU/602

Identifier Type: -

Identifier Source: org_study_id