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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02897856 |
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Date of registration:
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04/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
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Scientific title:
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Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02897856 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Qatar
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Seizures
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Intervention(s)
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Drug: Intramuscular midazolam
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Drug: Buccal midazolam
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Primary Outcome(s)
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Cessation of seizure activity five minutes after treatment with study medication.
[Time Frame: five minutes]
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Secondary Outcome(s)
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Major side effects.
[Time Frame: 2 hours after cessation of seizures.]
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Recurrence of seizure activity within one hour after treatment with study medication.
[Time Frame: one hour]
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Duration of seizure.
[Time Frame: 5 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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