The aim of this study is determination of the efficacy of intramuscular midazolam in comparison with the rectal gel diazepam in controlling the status epilepticus in children. A double blind, randomized, clinical trial in 80 children with age of one month and up to 16 years in two centers. Inclusion criteria: Age of one month and up to 16 years, Status epilepticus more than 5 minutes. Exclusion criteria: Having an established IV access on arrival to emergency departments, Use of benzodiazepines prior arrival to the emergency departments, Serial seizures and having a history of serious adverse reactions to IM midazolam or rectal diazepam. In midazolam group, IM midazolam will be used with a dose of 0.3 mg/kg ( Maximum 15 mg) following by rectal tube placebo and IM placebo following by rectal diazepam will be used with a dose of 0.5 mg/kg (Maximum 10 mg). Midazolam will be injected into the left quadriceps muscle if the child is younger than two years and if the child is older than two years the left deltoid muscle will be considered for injection. In the diazepam group, the rectal gel tube will be inserted into the rectum and to ensure that the drug is administered correctly, the buttocks will be kept high together for 5 min to prevention expulsion and then the tube will be removed. The primary outcome is stopping seizures within less than 10 minutes and a lack of recurrence of motor activity 60 minutes after the seizure. Secondary outcomes include side effects of medications, Time of prescribe medication to cessation seizure, Time from arrival to emergency department until prescribe medication, And time arrival of patients to the emergency department until the seizure stopped.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017031529801N3
Registration date:2017-11-05, 1396/08/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Saeid Sadeghiyan
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 134 4848
Email address
b_sadeghian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Intramuscular Midazolam versus Rectal Gel Diazepam in controlling status epilepticus in children: A randomized double-blind clinical trial
Public title
Efficacy of Intramuscular Midazolam versus Rectal Gel Diazepam in controlling status epilepticus in children: A randomized double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of one month and up to 16 years, Status epilepticus more than 5 minutes during arrival to emergency department.
Exclusion criteria: Having an established IV access on arrival to emergency departments, Use of nasal and rectal benzodiazepines prior arrival to the emergency departments by parents or paramedics, Parents discontent to participate in the study, Serial seizures without recovery of consciousness between seizures, and having a history of serious adverse reactions to IM midazolam or rectal diazepam.
Age
From 1 month old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the randomization will be done using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
Golestan street, Shahre Daneshgahi, Vice chancellor for research of Ahwaz University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
-
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.AJUMS.REC.1396.411
Health conditions studied
1
Description of health condition studied
Status epilepticus in children
ICD-10 code
G40-G47
ICD-10 code description
G40.3
Primary outcomes
1
Description
Stopping of all motor activity after drug administration without recurrence within 60 min after stopping of seizure
Timepoint
After drug administration until 60 minutes later
Method of measurement
Visual analogue scale and digital chronometer
Secondary outcomes
1
Description
Time to cessation after medication
Timepoint
Once and after prescribing the medication
Method of measurement
Digital chronometer
2
Description
Time from arrival to administer medication
Timepoint
Once and after prescribing the medication
Method of measurement
Digital chronometer
3
Description
Time to cessation after arrival
Timepoint
Once and after prescribing the medication
Method of measurement
Digital chronometer
4
Description
Medication side effects
Timepoint
After drug administration
Method of measurement
Monitoring of vital signs and symptoms developed up to 60 minutes after intervention
Intervention groups
1
Description
Intervention group 1: Midazolam, a dose of 0.3 mg per kg (maximum 15 mg), intramuscular, along with a placebo rectal gel tube, once when arrival to emergency department
Category
Treatment - Drugs
2
Description
Intervention group 2: Diazepam, a dose of 0.5 mg per kg (maximum 10 mg),rectal gel tube,along with intramuscular placebo, once when arrival to emergency department
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Emergency Department, Abuzar Hospital
Full name of responsible person
Saeid Sadeghian
Street address
Parastar (tohid) Street , Chaharshir, Abuzar Hospital, Ahvaz