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Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial (NCT02897856)

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.
  • Drug: Buccal midazolam
    Study subject will receive Buccal midazolam, Intramuscular placebo.
    • Drug: Intramuscular midazolam
      Study subject will receive Intramuscular midazolam,Buccal placebo
      Ages eligible for Study
      6 Months to 14 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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
      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.

      1 locations

      Qatar (1)
      • Hamad medical corporation
        recruiting
        Doha, Qatar, 3050
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      Start:
      30 November, 2015
      Updated:
      21 February, 2017
      Participants:
      150
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