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Completed

NCT Number: NCT02897856

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

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.

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Key information

Conditions

Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamad medical corporation

Doha, 3050, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buccal midazolam

Drug

Study subject will receive Buccal midazolam, Intramuscular placebo.

Intramuscular midazolam

Drug

Study subject will receive Intramuscular midazolam,Buccal placebo

Primary outcomes

  1. Cessation of seizure activity five minutes after treatment with study medication.

    Time frame: five minutes

    Cessation of abnormal motor activity with regaining of consciousness.

Secondary outcomes

  1. Major side effects.

    Time frame: 2 hours after cessation of seizures.

  2. Duration of seizure.

    Time frame: 5 minutes

  3. Recurrence of seizure activity within one hour after treatment with study medication.

    Time frame: one hour

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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