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Futility
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| Name | Class |
|---|---|
| Ospedali Riuniti Ancona | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| University of Padova | OTHER |
| Bambino Gesù Hospital and Research Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketamine up to 100 mcg/kg/min | Experimental | 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. |
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| midazolam & thiopental & propofol | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Intravenous administration in continuous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with resolution of refractory convulsive status epilepticus | participant wil be followed for 24 hours after discontinuation of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Rosati, MD, PhD | Children's Hospital A. Meyer of Firenze, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anna Rosati | Florence | 50139 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30232735 | Derived | Rosati A, De Masi S, Guerrini R. Ketamine for Refractory Status Epilepticus: A Systematic Review. CNS Drugs. 2018 Nov;32(11):997-1009. doi: 10.1007/s40263-018-0569-6. | |
| 27311915 | Derived | Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitano S, Battaglia D, Pettenazzo A, Sartori S, Biban P, Fontana E, Cesaroni E, Mora D, Costa P, Meleleo R, Vittorini R, Conio A, Wolfler A, Mastrangelo M, Mondardini MC, Franzoni E, McGreevy KS, Di Simone L, Pugi A, Mirabile L, Vigevano F, Guerrini R. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01). BMJ Open. 2016 Jun 15;6(6):e011565. doi: 10.1136/bmjopen-2016-011565. |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER |
| Catholic University of the Sacred Heart | OTHER |
| IRCCS Burlo Garofolo | OTHER |
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
| Nuovo Regina Margherita Hospital | OTHER |
| Vittore Buzzi Children's Hospital | OTHER |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |