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

NCT05670509 | Completed Phase 4 DMC

• 1 other identifier: fmasu md 19 1 2019
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• 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

Study Arms (6)

Nasal administration of midazolam in home group

EXPERIMENTAL

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

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

buccal administration of midazolam in home group

EXPERIMENTAL

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

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

intramuscular administration of midazolam in home group

EXPERIMENTAL

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

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

Nasal administration of midazolam in ER group

EXPERIMENTAL

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.

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

buccal administration of midazolam in ER group

EXPERIMENTAL

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

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

Intramuscular administration of midazolam in ER group

EXPERIMENTAL

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

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

Interventions

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

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

Nasal administration of midazolam in home group

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

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

buccal administration of midazolam in home group

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

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

intramuscular administration of midazolam in home group

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

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

Nasal administration of midazolam in ER group

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

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

buccal administration of midazolam in ER group

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

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

Intramuscular administration of midazolam in ER group

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 1 months and 17 years
• children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home
• Patients with generalized tonic-clonic status epilepticus with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration:
• Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour
• Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness
• Currently presenting with a single seizure (convulsive) lasting \>=5 minutes

You may not qualify if:

• Any child who had received an anticonvulsant benzodiazepine agent within 1 hour of presentation
• Patients with known history of hypersensitivities, non-responsiveness or contraindications to benzodiazepines (i.e., clinically significant respiratory depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea, glaucoma with closed angle, use of concomitant drugs determined by the investigator to have a contraindication to the use of bbenzodiazepines.)
• Patients with significant hypotension and cardiac dysrhythmia (e.g. atrioventricular block of second or third degree, ventricular tachycardia\]).
• Patients with current hypoglycemia (glucose \<60 milligram per deciliter \[mg/dl\]) on presentation at the hospital or healthcare setting.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Pediatric hospital

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Seizures

Interventions

Group Homes

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Residential Facilities; Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Omnia El Rashidy, MD

  Ain Shams University

  STUDY CHAIR

• Iman Ali, MD

  Ain Shams University

  STUDY CHAIR

• Maha El Gafary, MD

  Ain Shams University

  STUDY CHAIR

• Maha zakariya Mohammed, MD

  Ain Shams University

  STUDY CHAIR

• Rana El Garhy, master

  Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two major groups were included (home and ER group) and each were subdivided into 3 groups according to route of administration (nasal, buccal and IM)

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: January 4, 2023
• Study Start: January 19, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 1, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)