Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures

PHASE4CompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

January 19, 2019

Primary Completion Date

July 31, 2022

Study Completion Date

July 31, 2022

Conditions
Convulsions
Interventions
DRUG

administration of Nasal midazolam in home group as a rescue medication for seizure control.

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

DRUG

administration of Buccal midazolam in home group as a rescue medication for seizure control.

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

DRUG

administration of intramuscular midazolam in homegroup as a rescue medication for seizure control.

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

DRUG

administration of Nasal midazolam in ER group as a rescue medication for seizure control.

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

DRUG

administration of Buccal midazolam in ER group as a rescue medication for seizure control.

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

DRUG

administration of intramuscular midazolam in ER group as a rescue medication for seizure control.

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

Trial Locations (1)

002

Ain Shams Pediatric hospital, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT05670509 - Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures | Biotech Hunter | Biotech Hunter