Trial reportBMJ open2016
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).
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02431663 (Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- Drug management for acute tonic-clonic convulsions including convulsive status epilepticus in children.The Cochrane database of systematic reviews · 2018Pooled it
- KETASER01 protocol: What went right and what went wrong.Epilepsia open · 2022Trial
- An Italian Survey on the Management of Pediatric Convulsive Status Epilepticus: More Than Just a Pharmacological Choice.Brain and behavior · 2025Article
- Multicenter Retrospective Review of Ketamine Use in Pediatric Intensive Care Units (Ketamine-PICU Study).Critical care research and practice · 2024Article
- Treatment of pediatric convulsive status epilepticus.Frontiers in neurology · 2023Review
- Efficacy and safety of ketamine for neonatal refractory status epilepticus: case report and systematic review.Frontiers in pediatrics · 2023Review
- Ketamine administration in idiopathic epileptic and healthy control dogs: Can we detect differences in brain metabolite response with spectroscopy?Frontiers in veterinary science · 2022Article
- Sevoflurane as bridge therapy for plasma exchange and Anakinra in febrile infection-related epilepsy syndrome.Epilepsia open · 2021Article
- Refractory symptoms in paediatric palliative care: can ketamine help?Drugs in context · 2021Review
- Ketamine Prolonged Infusions in the Pediatric Intensive Care Unit: a Tertiary-Care Single-Center Analysis.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Treatment of Refractory Convulsive Status Epilepticus: A Comprehensive Review by the American Epilepsy Society Treatments Committee.Epilepsy currents · 2020Article
- Barriers to Perinatal Palliative Care Consultation.Frontiers in pediatrics · 2020Article
- Pharmacotherapy for Pediatric Convulsive Status Epilepticus.CNS drugs · 2020Review
- Recent advances in epilepsy.Journal of neurology · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors at 14 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionStatus epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as 'refractory' (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-d-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE. METHODS AND ANALYSIS: A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method. ETHICS AND DISSEMINATION: The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT02431663; Pre-results.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.