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

Summary

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

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

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• 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

• Rana El Garhy, master · Ministry of Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-19

Primary Completion

2022-07-31

Completion

2022-07-31

Countries

• Egypt

Study Locations