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

Seizures Clinical Trial

Official title:

A Randomized Controlled Trial Comparing the Efficacy of Intranasal Midazolam and Conventional Treatment With Intravenous Diazepam for Control of Seizures in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04885075
• Other study ID #: No.F.1-1/2015/ERB/SZABMU/602
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 30, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2021
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: zunash fateh, mbbs
• Phone: 03344360704
• Email: zunash.ammar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Seizures

Intervention

Drug:
• IV diazepam
inj.diazepam 0.2mg/kg/dose stat
• I/N Midazolam
intranasal midazolam 0.2mg/kg/dose stat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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