Health Condition 1: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Intramuscular Fosphenytoin (route of administration): 50 mg PE per ml fosphenytoin vial will be used.
Dose: Intramuscular fosphenytoin 18-20 mg PE per kilogram will be administered, 2-
Sponsors
Dr Kavita Srivastava
Eligibility
Inclusion criteria
Inclusion criteria: Pediatric patients with age 2 months to 6 years, diagnosed with convulsive SE and who will be treated with consensually accepted cumulative dose of benzodiazepine (preferably midazolam nasal-spray), lasting or continue to have seizures for more than 5 minutes and no more than 30 minutes after the last dose of benzodiazepines. The minimal adequate cumulative doses of benzodiazepines will be defined as diazepam at a dose of 0.3 mg per kilogram of body weight (administered intravenously or rectally), lorazepam at a dose of 0.1 mg per kilogram (administered intravenously), or midazolam at a dose of 0.3 mg of per kilogram (administered intramuscularly) or 0.2 mg per kilogram (administered intravenously or intranasally) for children who weighed less than 32 kg. These drugs may have been administered in divided doses, including prior to patient’s arrival in the emergency department (out-hospital SE).
Exclusion criteria
Exclusion criteria: The study will exclude patients who are already on antiseizure medication/s for the long-term control of seizure. Those patients will also be randomly assigned to a treatment groups without regard to their antiseizure medication/s type. Patients who arrive at the emergency department with one of the following conditions will be excluded from the study: patients with major head trauma as the acute precipitant of the seizure; cardiac arrest; or a hear rate less than 40 beats per minute (since these conditions require alternative treatments). Patients who have priorly received treatment for their present episode of status epilepticus using antiseizure medications other than benzodiazepines or who have had their trachea intubated will be excluded from the study. Patients with known allergy or contraindications to fosphenytoin, also the patients with comorbid conditions like known inborn metabolic disorder, cardiac arrhythmias, or severe renal impairment, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy: Proportion of patients with clinical seizure cessation at 30-minutes after administration of study-drugs, and electrographic seizure cessation at 2-hours after administration of loading-dose of the study-drugs. Improvement in the responsiveness at 60-minutes after the start of trial-drug, and no requirement of additional ASM. Primary safety: Composite of life-threatening-hypotension or cardiac-arrhythmia within 60-minutes after the start of study-drug-infusion.Timepoint: Clinical seizure cessation at 30-minutes after administration of the study-drugs. Electrographic seizure cessation 2-hours after administration of loading dose of the study-drugs. Improvement in the responsiveness at 60-minutes after the start of study-drugs. Composite of life-threatening-hypotension or cardiac-arrhythmia within 60-minutes after the start of study-drug-infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy outcome measure is the time required for seizure cessation or termination from the start of the study drug from either arm; admission to the intensive-care unit (ICU); length of ICU hospitalisation and overall hospital stay in days. The time interval between the start of the trial drug and cessation of the clinically apparent seizures will be referred as ‘time to seizure termination’. Additional safety measures include endotracheal or tracheostomy intubation within 60 minutes, acute seizure recurrence between 60 minute to 12 hours, and acute anaphylaxis after the start of study drug infusion through IV or after the administration of IM injection.Timepoint: Acute seizure recurrence between 60 minute to 12 hours. | — |
Countries
India
Contacts
Public ContactDr Vaibhav Suryawanshi
BVDUs Poona College of Pharmacy, Pune
Outcome results
None listed