Ketamine plus levetiracetam versus levetiracetam alone to stop prolonged generalized seizures in children
Efficacy of Combined Ketamine and Levetiracetam as a Second-line Anti-seizure Medication for Generalized Convulsive Status Epilepticus in Children
This trial will try giving ketamine together with levetiracetam versus levetiracetam with placebo to stop benzodiazepine‑refractory generalized convulsive status epilepticus in children aged 1–16 years.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07046611 on ClinicalTrials.gov |
What this trial studies
Children aged 1–16 who present to the emergency department with generalized convulsive status epilepticus that continues after adequate benzodiazepine dosing will receive either ketamine plus levetiracetam or levetiracetam with placebo as second‑line intravenous therapy. Treatments are administered acutely in the hospital setting and outcomes focus on termination of convulsive activity and short‑term clinical course. The protocol excludes patients previously treated with non‑benzodiazepine antiseizure medications for the current episode, those already intubated, and specific acute medical conditions such as traumatic brain injury or post‑anoxic seizures. Data from this study will compare seizure control rates and immediate safety between the combination and standard therapy.
Who should consider this trial
Good fit: Children 1–16 years old with clinically observed generalized tonic‑clonic seizures lasting longer than 5 minutes that continue or recur after an adequate benzodiazepine dose (last dose given 5–30 minutes earlier) and who have IV access are ideal candidates.
Not a fit: Children with acute traumatic brain injury, post‑anoxic or cardiac‑arrest seizures, significant hypo‑ or hyperglycemia, prior treatment with second‑line antiseizure drugs for this episode, prior endotracheal intubation, or known allergy/contraindication to ketamine or levetiracetam would not be eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, early combination therapy could stop ongoing seizures faster, lowering the risk of brain injury and long‑term neurological problems.
How similar studies have performed: Observational series and recent adult and pediatric reports have suggested ketamine can terminate refractory status epilepticus, but randomized pediatric data on early ketamine plus levetiracetam remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 1 year to 16 years. * Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5 minutes. * Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the last dose administered within 5 to 30 minutes. Exclusion Criteria: * Failure to obtain informed consent. * Prior treatment with antiseizure medication or anticonvulsant sedatives other than benzodiazepines for the presenting GCSE episode. * Endotracheal intubation before enrollment. * Acute traumatic brain injury. * Cardiac arrest/post-anoxic seizures * Hypoglycemia or hyperglycemia. * Known allergies or contraindications to ketamine or levetiracetam * Failure to obtain intravenous access.
Where this trial is running
Sohag
- Department of Pediatrics at Sohag University Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Elsayed Abdelkreem, MD, PhD
- Email: d.elsayedmohammed@med.sohag.edu.eg
- Phone: 1114232126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.