Trial Outcomes & Findings for Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures (NCT NCT00326612)

NCT ID: NCT00326612

Last Updated: 2011-10-26

Results Overview

Length of seizure.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 358 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2011-10-26

Participant Flow

Recruited from a pediatric Neurology clinic.

Participant milestones

Measure	Intranasal Midazolam 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes	Rectal Diazepam 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
Overall Study STARTED	179	179
Overall Study COMPLETED	50	42
Overall Study NOT COMPLETED	129	137

Reasons for withdrawal

Measure	Intranasal Midazolam 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes	Rectal Diazepam 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
Overall Study They did not have a seizure requiring tx	129	137

Baseline Characteristics

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

Baseline characteristics by cohort

Measure	Intranasal Midazolam n=50 Participants 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes	Rectal Diazepam n=42 Participants 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	42 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	6.8 years STANDARD_DEVIATION 5.0 • n=5 Participants	7.3 years STANDARD_DEVIATION 4.5 • n=7 Participants	7.0 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	42 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Analysis was per protocol

Length of seizure.

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Length of Seizure After Study Medication Administration	3.0 Minutes Inter-Quartile Range 15.7 • Interval 1.0 to 10.0	4.3 Minutes Inter-Quartile Range 11.3 • Interval 2.0 to 14.5

SECONDARY outcome

Timeframe: 24 hours

Population: Analysis was per protocol

Respiratory depression was defined as intubation at Emergency Department discharge.

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Respiratory Depression Requiring Intubation	1 participants Interval 0.0 to 8.3	0 participants Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours	5 participants Interval 2.0 to 12.0	5 participants Interval 4.0 to 15.0

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.	21 participants	17 participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.	4 participants Interval 1.0 to 10.0	3 participants Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication	1 participants Interval 0.0 to 5.0	1 participants Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 24 hours

Population: Analysis was per protocol

Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.

Outcome measures

Measure	Intranasal Midazolam n=50 Participants Median time to seizure cessation from medication administration to seizures stop time.	Rectal Diazepam n=42 Participants Median time to seizure cessation from medication administration to seizures stop time.
Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.	3 participants	1 participants

Adverse Events

Intranasal Midazolam

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Rectal Diazepam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intranasal Midazolam n=50 participants at risk 0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes	Rectal Diazepam n=42 participants at risk 0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
Respiratory, thoracic and mediastinal disorders Intubation	2.0% 1/50 • Number of events 1	0.00% 0/42

Other adverse events

Adverse event data not reported

Additional Information

Maija Holsti, MD, MPH

DIvision of Pediatric Emergency Medicine

Phone: 801-587-7450

Email: maija.holsti@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place