drugset / Trial / NCT02431663
Ketamine in Refractory Convulsive Status Epilepticus
Phase 3
Terminated
57 enrolled
Meyer Children's Hospital IRCCS
Azienda Ospedaliera Universitaria Integrata Verona · collabBambino Gesù Hospital and Research Institute · collabCatholic University of the Sacred Heart · collabIRCCS Azienda Ospedaliero-Universitaria di Bologna · collabIRCCS Burlo Garofolo · collabNuovo Regina Margherita Hospital · collabOspedali Riuniti Ancona · collabUniversity of Padova · collabVittore Buzzi Children's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-04
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped: “Futility”
paper TRIAL REGISTRATION NUMBER: NCT02431663; Pre-results. PMID 27311915 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 60 ug/kg | Intravenous |
Indications
No indication recorded.