ConvulsionsPhase 4NCT05670509
Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures
A Phase 4 study of Convulsions, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Convulsions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2019to 31 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures in Pediatric Egyptian Patients
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
Read the detailed description
Recruited patients randomized using previously computer-generated randomization tables prepared by expert statistician. Study was approved by the faculty ethical committee prior to its start and oral informed consent was obtained from the parents. In order to simplify the administration process a reference guide was prepared for doses according to weight for each of the 3 routes.
Two major groups were included (home and ER group) and each were subdivided into 3 groups according to route of administration
Children was randomly assigned to receive treatment with intranasal, intramuscular or buccal midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) .Intranasal form was administered 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. Administration was via sprays in each nostril (for nasal) or dripping between the cheek and the gum per side using insulin syringe (for buccal) or using 3 mm syringe in the front aspect of thigh for intramuscular injection.
Caretakers who gave the study medication recorded their observations and answered a series of questions regarding time to drug administration, seizure cessation time, seizure recurrence, need for hospitalization or ER visits and any encountered difficulties or side effects. Ease of administration of was rated using a scale prepared by expert statistian from very easy to very difficult and overall satisfaction with the medication was rated using 10-point nominal scale (0, being not satisfied and 10, greatly satisfied). Seizures that did not cease for ten minutes after drug administration and the need to use additional medication was categorized as a treatment failure criteria.
Recruited caretakers who did not spontaneously report the use of the study medication were contacted by phone monthly to address any questions and to remind them of the study. Problems with different routes of delivery were discussed, for example excessive head movements, ryle or upper respiratory tract infections and where possible suggestions and advices to help with addressed issue was provided .If a caretaker reported use of study medication at the time of the phone call, information was obtained at that time. In this group, not all children received a benzodiazepine because of different reasons: unavailability of the drug at home or at school, spontaneous resolution of seizures, difficulty in administrating the drug, or panic.
ER doctor given a brief survey after the administration to evaluate sedation, discomfort and other adverse effects of the medication as well as any administration difficulties and data for other secondary outcomes (need for additional medical support, hospitalization, repeated seizures…etc).
- Conditions
- Convulsions
- Being tested
- administration of Nasal midazolam in home group as a rescue medication for seizure control., administration of Buccal midazolam in home group as a rescue medication for seizure control., administration of intramuscular midazolam in homegroup as a rescue medication for seizure control., administration of Nasal midazolam in ER group as a rescue medication for seizure control., administration of Buccal midazolam in ER group as a rescue medication for seizure control.
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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. Receives: 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 Receives: 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 Receives: Drug: administration of intramuscular midazolam in ER group as a rescue medication for seizure control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes post drug administration
Secondary outcomes (14)
sustained absence of seizure activity for at least 1 hour
Percentage of participants whose seizure event stopped within 10 minutes of single dose of anticonvulsant and who have sustained absence of seizure activity for at least 1 hour
Measured: from start of study drug administration up to 1 hour postdose
sustained absence of seizure activity for 4 hour
Percentage of participants whose seizure event stopped within 10 minutes of single dose of anticonvulsant and who have sustained absence of seizure activity for at least 4 hours
Measured: from start of study drug administration up to 4 hours postdose
sustained absence of seizure activity for 6 hour
Percentage of participants whose seizure event stopped within 10 minutes of single dose of anticonvulsant and who have sustained absence of seizure activity for at least 6 hours
Measured: from start of study drug administration up to 6 hours postdose
Time to resolution of seizures (convulsions)
Time to resolution of seizures (convulsions) after drug administration Cessation of seizure activity was defined as caregiver/physician-confirmed cessation of abnormal motor activity with at least partial recovery of consciousness
Measured: 30 minutes
Time of drug preparation and administration
time taken to prepare and administer drug
Measured: 45 minutes
Emergency department visits
Number of patients from home group who needed to go to ER after drug adminstration
Measured: 24 hours post drug administration
percentage of patients admitted to hospital
Number of patients that were admitted to the hospital or intensive care unit after their seizure and use of study medication.
Measured: 24 hours post drug administration
need for additional doses or additional drugs for seizure control
Percentage of participants who required additional anticonvulsant medication for ongoing status epilepticus (se) 10 minutes after single dose administration of anticonvulsant
Measured: 10 minutes post drug administration
Seizure recurrence at 1 ,4 , 6 and 24 hrs
Seizure recurrence at 1 ,4 , 6 and 24 hrs of cessation of presenting convulsion
Measured: 24 hours post drug administration
Respiratory depression
persistent decrease in oxygen saturation to <92% measured at 0, 10 minutes, 30 minutes, and 1, 4 , 6 hrs postdose (ie, <92% on room air for 2 minutes or more after dosing while monitoring aspiration pneumonia
Measured: 6 hours post drug administration
Sedation or agitation
- Sedation or agitation measured by a 7 point nominal scale where 1 represented deep sedation and 7 sever agitation
Measured: 4 hours post drug administration
Frequency of cardio-respiratory side effects
Frequency of cardio-respiratory side effects development of hypotension (fall of >/= 20 mmhg systolic and/ or >/= 10 mmhg diastolic pressure) within 0, 10 and 30 mins, 1, 4 , 6 hrs postdose of drug administration
Measured: 6 hours post drug administration
Occurrence of route of administration and benzodiazepine related side effects
Adverse events, including but not limited nasal irritation, dizziness, Stuffy nose, headache , nausea, agitation , cardiopulmonary dysfunction, ataxia, and abnormal vital signs were recorded
Measured: 6 hours post drug administration
Caretakers and physicians ease of administration and satisfaction with the medication
Ease of administration of was rated using a scale prepared by expert statistician from very easy to very difficult and overall satisfaction with the medication was rated using 10-point nominal scale (0, being not satisfied and 10, greatly satisfied
Measured: up to 1 months after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start19 Jan 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConvulsionsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omnia El Rashidy, MD, Study chair, Ain Shams UniversityIman Ali, MD, Study chair, Ain Shams UniversityMaha El Gafary, MD, Study chair, Ain Shams UniversityMaha zakariya Mohammed, MD, Study chair, Ain Shams UniversityRana El Garhy, master, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670509
- Sponsor's protocol ID
- fmasu md 19 1 2019
- Status last verified
- Dec 2022
- First submitted
- 8 Oct 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures in Pediatric Egyptian Patients
- ClinicalTrials.gov ID
- NCT05670509
- Acronym / sponsor ID
- fmasu md 19 1 2019
- Conditions
- Convulsions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Recruited patients randomized using previously computer-generated randomization tables prepared by expert statistician. Study was approved by the faculty ethical committee prior to its start and oral informed consent was obtained from the parents. In order to simplify the administration process a reference guide was prepared for doses according to weight for each of the 3 routes.
Two major groups were included (home and ER group) and each were subdivided into 3 groups according to route of administration
Children was randomly assigned to receive treatment with intranasal, intramuscular or buccal midazolam with doses of 0.2 mg/kg (maximum, 10 mg) body weight of the standard IV formulation of midazolam (5mg/mL) .Intranasal form was administered 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. Administration was via sprays in each nostril (for nasal) or dripping between the cheek and the gum per side using insulin syringe (for buccal) or using 3 mm syringe in the front aspect of thigh for intramuscular injection.
Caretakers who gave the study medication recorded their observations and answered a series of questions regarding time to drug administration, seizure cessation time, seizure recurrence, need for hospitalization or ER visits and any encountered difficulties or side effects. Ease of administration of was rated using a scale prepared by expert statistian from very easy to very difficult and overall satisfaction with the medication was rated using 10-point nominal scale (0, being not satisfied and 10, greatly satisfied). Seizures that did not cease for ten minutes after drug administration and the need to use additional medication was categorized as a treatment failure criteria.
Recruited caretakers who did not spontaneously report the use of the study medication were contacted by phone monthly to address any questions and to remind them of the study. Problems with different routes of delivery were discussed, for example excessive head movements, ryle or upper respiratory tract infections and where possible suggestions and advices to help with addressed issue was provided .If a caretaker reported use of study medication at the time of the phone call, information was obtained at that time. In this group, not all children received a benzodiazepine because of different reasons: unavailability of the drug at home or at school, spontaneous resolution of seizures, difficulty in administrating the drug, or panic.
ER doctor given a brief survey after the administration to evaluate sedation, discomfort and other adverse effects of the medication as well as any administration difficulties and data for other secondary outcomes (need for additional medical support, hospitalization, repeated seizures…etc).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Nasal administration of midazolam in home group | Experimental | Drug: administration of Nasal midazolam in home group as a rescue medication for seizure control.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 |
| buccal administration of midazolam in home group | Experimental | Drug: administration of Buccal midazolam in home group as a rescue medication for seizure control.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 |
| intramuscular administration of midazolam in home group | Experimental | Drug: administration of intramuscular midazolam in homegroup as a rescue medication for seizure control.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 |
| Nasal administration of midazolam in ER group | Experimental | Drug: administration of Nasal midazolam in ER group as a rescue medication for seizure control.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. |
| buccal administration of midazolam in ER group | Experimental | Drug: administration of Buccal midazolam in ER group as a rescue medication for seizure control.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 |
| Intramuscular administration of midazolam in ER group | Experimental | Drug: administration of intramuscular midazolam in ER group as a rescue medication for seizure control.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 |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Nasal administration of midazolam in home group |
| 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 | buccal administration of midazolam in home group |
| 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 | intramuscular administration of midazolam in home group |
| 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 | Nasal administration of midazolam in ER group |
| 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 | buccal administration of midazolam in ER group |
| 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 | Drug | Intramuscular administration of midazolam in ER group |
Primary outcome
Percentage of participants with therapeutic success
Time frame: 30 minutes post drug administration
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
14 secondary outcomes
sustained absence of seizure activity for at least 1 hour
Time frame: from start of study drug administration up to 1 hour postdose
sustained absence of seizure activity for 4 hour
Time frame: from start of study drug administration up to 4 hours postdose
sustained absence of seizure activity for 6 hour
Time frame: from start of study drug administration up to 6 hours postdose
Time to resolution of seizures (convulsions)
Time frame: 30 minutes
Time of drug preparation and administration
Time frame: 45 minutes
Emergency department visits
Time frame: 24 hours post drug administration
percentage of patients admitted to hospital
Time frame: 24 hours post drug administration
need for additional doses or additional drugs for seizure control
Time frame: 10 minutes post drug administration
Seizure recurrence at 1 ,4 , 6 and 24 hrs
Time frame: 24 hours post drug administration
Respiratory depression
Time frame: 6 hours post drug administration
Sedation or agitation
Time frame: 4 hours post drug administration
Frequency of cardio-respiratory side effects
Time frame: 6 hours post drug administration
Occurrence of route of administration and benzodiazepine related side effects
Time frame: 6 hours post drug administration
Caretakers and physicians ease of administration and satisfaction with the medication
Time frame: up to 1 months after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omnia El Rashidy, MD study chair
Ain Shams University
Iman Ali, MD study chair
Ain Shams University
Maha El Gafary, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Convulsions, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with therapeutic success (time frame: 30 minutes post drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.