NCT05670509|CompletedPhase 4DMC
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Sponsor study identifier
interventional
305
1 country
1
Study Start
January 19, 2019
Actual (reported)Primary Completion
July 31, 2022
Actual (reported)Study Completion
July 31, 2022
Actual (reported)A randomized controlled clinical trial comparing patient/ ER physician satisfaction and ease of administration of 3 non IV routes of midazolam as a rescue medication for seizure control. Study population included children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home and those presenting to ER with following inclusion and exclusion criteria
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2019
Actual (reported)July 31, 2022
Actual (reported)July 31, 2022
Actual (reported)October 8, 2022
Actual (reported)January 4, 2023
Actual (reported)Percentage of participants with therapeutic success
Percentage of participants with therapeutic success defined as cessation of visible seizure activity within 10 minutes (mins) with a sustained absence of visible seizure activity for 30 minutes following a single dose of anticonvulsant agent time frame: from start drug administration up to 30 minutes postdose \] i.e Successful responder (onset of seizure cessation within 10 minutes or duration of seizure control \>30 minutes without seizure relapse), or Unsuccessful/nonresponder (onset of seizure cessation \>10 minutes or duration of seizure control \<30 minutes
30 minutes post drug administration
sustained absence of seizure activity for at least 1 hour
from start of study drug administration up to 1 hour postdose
sustained absence of seizure activity for 4 hour
from start of study drug administration up to 4 hours postdose
sustained absence of seizure activity for 6 hour
from start of study drug administration up to 6 hours postdose
Time to resolution of seizures (convulsions)
30 minutes
Time of drug preparation and administration
45 minutes
treatment with intranasal midazolam in children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via a metered dose sprayer at 0.1 mL/spray (i.e. 0.5mg/spray). If the volume to be administered exceeded 1 mL, then the dose was divided between both nostrils to avoid runoff and swallowing. children with known seizure disorder who were prescribed midazolam by pediatric neurologist
treatment with buccal midazolam in children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via dripping between the cheek and the gum per side using insulin syringe
Children from home group assigned to receive treatment with intranasal midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via a metered dose sprayer at 0.1 mL/spray (i.e. 0.5 mg/spray). If the volume to be administered exceeded 1 mL, the dose was divided between both nostrils to avoid runoff and swallowing
Ain Shams Pediatric hospital
Cairo, 002, Egypt
Omnia El Rashidy, MD
Ain Shams University
Iman Ali, MD
Ain Shams University
Maha El Gafary, MD
Ain Shams University
Maha zakariya Mohammed, MD
Ain Shams University
305 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2022
First Posted
January 4, 2023
Study Start
January 19, 2019
Actual (reported)treatment with intramuscular midazolam in children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) administered via using 3 mm syringe in the front aspect of thigh
treatment with intranasal midazolam in children presenting to ER with acute seizures with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via a metered dose sprayer at 0.1 mL/spray (i.e. 0.5mg/spray). If the volume to be administered exceeded 1 mL, then the dose was divided between both nostrils to avoid runoff and swallowing.
treatment with buccal midazolam in children presenting to ER with acute seizures with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via dripping between the cheek and the gum per side using insulin syringe
treatment with intramuscular midazolam in children presenting to ER with acute seizures with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) administered via using 3 mm syringe in the front aspect of thigh
Children from home group randomly assigned to receive treatment with buccal midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via dripping between the cheek and the gum per side using insulin syringe
Children from home group randomly assigned to receive treatment with intramuscular midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) using 3 mm syringe in the front aspect of thigh
Children from the ER group assigned to receive treatment with intranasal midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via a metered dose sprayer at 0.1 mL/spray (i.e. 0.5 mg/spray). If the volume to be administered exceeded 1 mL, the dose was divided between both nostrils to avoid runoff and swallowing
Children from ER group randomly assigned to receive treatment with buccal midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) via dripping between the cheek and the gum per side using insulin syringe
Children from ER group randomly assigned to receive treatment with intramuscular midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) using 3 mm syringe in the front aspect of thigh
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Rana El Garhy, master
Ministry of Health
Primary Completion
July 31, 2022
Actual (reported)Study Completion
July 31, 2022
Actual (reported)Last Updated
February 1, 2024
Record last verified: 2022-12
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