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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02897856

Enrollment

150

Registered

2016-09-13

Start date

2016-09-30

Completion date

2018-11-30

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizures

Brief 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.

Detailed 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.

Interventions

DRUGBuccal midazolam

Study subject will receive Buccal midazolam, Intramuscular placebo.

DRUGIntramuscular midazolam

Study subject will receive Intramuscular midazolam,Buccal placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cessation of seizure activity five minutes after treatment with study medication.	five minutes	Cessation of abnormal motor activity with regaining of consciousness.

Secondary

Measure	Time frame
Major side effects.	2 hours after cessation of seizures.
Duration of seizure.	5 minutes
Recurrence of seizure activity within one hour after treatment with study medication.	one hour

Countries

Qatar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026