Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271096
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2024-02-07
Brief Title:
Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children
Sponsor:
Arooj Khan
Organization:
Khyber Teaching Hospital
Study Overview
Official Title:
Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IM-midazolam in acute seizures whenever IV cannulation is not possible It is easy to administer and can be used in prehospital settings as IV cannulation requires experience especially in pediatric age group Moreover the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures
Detailed Description:
A seizure or convulsion is a time-limited paroxysmal change in motor activity and or behavior that results from electrical activity in the brain that is abnormal1 The emergency department of a hospital is usually the place where children with seizures receive first treatment and medical support Seizures make up about 1 of all emergency department visits for pediatric patients and at least 5 of pediatric patients will have a seizure by the time they are 16 years old Children younger than one year of age are commonly affected by new and unprovoked seizures2 Seizures can result in continuous muscular activity which leads to tissue breakdown because of anaerobic metabolism as well as decreasing oxygen and glucose to the brain causing brain ischemia and neuronal death So the seizures must be controlled rapidly to decrease the systemic as well as brain damage34 First-line anticonvulsants for the treatment of acute seizures are benzodiazepines Diazepam is frequently used for the treatment of seizures because it can be delivered either intravenously or rectally It is lipophilic so does not have proper intramuscular absorption Precious time is spent in getting intravenous access or per rectal catheterization While midazolam is a lipid-soluble benzodiazepine rapidly absorbed after intramuscular IM injection56 For managing seizure the drug should be sufficiently potent to allow small volume and an administration that is quick easy and safe with quick action and little monitoring7 Intramuscular midazolam meets these criteria and may be useful for the treatment of seizures but more trials are needed to see the safety and efficacy of this therapy in the pediatric population8 A major chunk of the seizures may occur out of the hospital For the parents its frightening to see their kid in fits Usually these parents immediately take their child to the nearby hospital or clinic But its not possible for all the parents because in many areas health facilities are not present Hence these patients are at increased risk for sustaining post ictal brain damage There is a long-awaited wish that how to prevent this brain damage A lot of options are tried nowadays and also in the past like rectal diazepam sublingual midazolam but unfortunately most such options are not without risks
The objective of this study was to compare the time taken by intramuscular midazolam to stop the seizure as compared to intravenous diazepam in emergency cases in the pediatric age group
The objective of this study was to compare the time taken by intramuscular midazolam to stop the seizure as compared to intravenous diazepam in emergency cases in the pediatric age group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None