Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures

Seizures Clinical Trial

Official title:

Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897856
• Other study ID #: 14-00050
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2019
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.

Description:

Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.

In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 14 Years

Eligibility

Inclusion Criteria:

• Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.

Exclusion Criteria:

• Cardiac arrest

• Head trauma

• Drowning

• Congenital heart disease

• Inborn errors of metabolism

• Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)

• Hemodynamic instability

• Allergy to benzodiazepines

• Focal seizures with preserved level of consciousness

Related Conditions & MeSH terms

• Seizures

Intervention

Drug:
• Buccal midazolam
Study subject will receive Buccal midazolam, Intramuscular placebo.
• Intramuscular midazolam
Study subject will receive Intramuscular midazolam,Buccal placebo

Locations

Country	Name	City	State
Qatar	Hamad medical corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of seizure activity five minutes after treatment with study medication.	Cessation of abnormal motor activity with regaining of consciousness.	five minutes
Secondary	Major side effects.		2 hours after cessation of seizures.
Secondary	Duration of seizure.		5 minutes
Secondary	Recurrence of seizure activity within one hour after treatment with study medication.		one hour