Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam

Status Not yet recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Seizures

Clinical Trial Details

NCT number	NCT04885075
Study type	Interventional
Source	Shaheed Zulfiqar Ali Bhutto Medical University
Contact	zunash fateh, mbbs
Phone	03344360704
Email	zunash.ammar@gmail.com
Status	Not yet recruiting
Phase	Phase 4
Start date	May 30, 2021
Completion date	November 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms