A Phase 3 interventional study of Ketamine in Status Epilepticus, sponsored by Meyer Children's Hospital IRCCS. Terminated at 1 site in Italy. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Meyer Children's Hospital IRCCS · Phase 3, Interventional, and Treatment
To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.
126 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 74 interventional studies indexed under Status Epilepticus.
Browse Status Epilepticus studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days.
Drug: Ketamine
Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h. Maximum duration of infusion for each drug will be 48 hours.
Drug: Ketamine
Intravenous administration in continuous
Also known as: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)
Number of participants with resolution of refractory convulsive status epilepticus
Time frame: participant wil be followed for 24 hours after discontinuation of study drug
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Meyer Children's Hospital IRCCS