Convulsive Status EPILEPTICUSPhase 2/3PEAK-SEEKNCT07095842
Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
A Phase 2/3 study testing Ketamine and Midazolam in people with Convulsive Status EPILEPTICUS, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Convulsive Status EPILEPTICUS
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2025to 1 Aug 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 2 to 16 years.
- Established diagnosis of epilepsy of at least 1 year duration.
- History of at least 1 episode of convulsive status epilepticus in the preceding 12 months.
Who cannot join
- Failure to obtain informed consent.
- Known allergies or contraindications to ketamine.
- Known contraindications to intramuscular injection.
- Presence of another family member included in the same trial.
- Having subsequent events (only the index event will be included).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Pediatrics at Sohag University Hospital
Sohag, 82524
Abdelrahim A Sadek, MD, PhD, abdoneurology@yahoo.com
About this study
Official title: Efficacy of Add-on Ketamine With Second-dose Midazolam for Prehospital Treatment of Epileptic Children With Status Epilepticus
The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus.
Read the detailed description
Status epilepticus (SE) is the most prevalent neurological emergency in children. Benzodiazepines (BDZs) remain the first-line anti-seizure medication (ASM) for SE, but about one-third of seizures are not controlled by BDZs. Moreover, second-line ASMs (levetiracetam, valproate, phenytoin) fail to terminate BDZ-refractory SE in 50% of cases. Such prolonged SE is linked with progressive brain damage and an increased risk of epilepsy, irreversible neurodevelopmental sequelae, and mortality. Accordingly, early control of SE is critical for enhancing clinical outcomes.
A possible strategy for rapid control of SE is using early ASM combination. Ketamine seems a promising choice for such a combination. Ketamine acts to antagonize N-methyl-D-aspartate (NMDA) receptors, which become increasingly upregulated and trafficked to the synaptic membrane during ongoing seizure activity. Numerous observational studies have demonstrated that administration of ketamine is associated with termination or attenuation of refractory SE (RSE) and super-refractory SE (SRSE). Furthermore, the recently published Ket-Mid study showed that the ketamine-midazolam combination was more effective than midazolam alone in the initial treatment of pediatric generalized CSE. However, the Ket-Mid study also highlighted a significant delay in hospital arrival and administration of first-line ASM, by a median of 34 minutes, reflecting delayed access to emergency care due to socioeconomic challenges, geographic barriers, and limited prehospital emergency medical services. Such a challenge also applies to resource-limited settings, where treatment delays are more common. Notably, a review by Gaínza-Lein et al. of 15 studies involving 2212 patients with SE reported average times to ASM treatment and hospital arrival of 42.4 and 56 minutes, respectively. Such delay to the administration of ASM is associated with increased resistance to BZDs, longer SE, and increased risk of complications. Accordingly, there is a growing interest in the early use of ASM for prehospital treatment of SE.
Ketamine has been used in prehospital setting for a long time, mainly for sedation and analgesia purposes with a high safety profile. Multiple observational studies have reported the efficacy of ketamine in the pre-hospital emergency treatment of BZD-refractory status epilepticus. However, this was not adequately investigated in clinical trials.
The present study (Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids, PEAK-SEEK) aims to investigate the efficacy of adding ketamine to second-dose midazolam vs. second-dose midazolam alone as ASM for prehospital treatment of epileptic children with convulsive status epilepticus.
- Conditions
- Convulsive Status EPILEPTICUS
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Intramuscular ketamine 2 mg/kg (max 90 mg)
MidazolamDrug
Intramuscular midazolam 0.2 mg/kg (max 10 mg)
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + Midazolam | Experimental | Not described Receives: Drug: Ketamine; Drug: Midazolam |
| Midazolam | Active comparator | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cessation of seizures at the time of hospital arrival
Number of participants with cessation of clinically evident seizures at the time of hospital arrival
Measured: At the time of hospital arrival (up to 1 hour)
Secondary outcomes (7)
Number of participants with sustained cessation of seizures
Number of participants with sustained cessation of clinically evident seizures at 10 minutes after study drug administration to 60-min after hospital arrival with improved responsiveness (verbal communication, obeying commands, or purposeful reaction to painful stimuli) and no endotracheal intubation or use of any additional antiseizure medications or anticonvulsant sedatives
Measured: From 10 minutes after study drug administration to 60-minutes after hospital arrival
Number of participants with recurrence of seizures
Number of participants with recurrence of clinically evident seizures after initial control at 10 minutes after study drug adminstration till 60-minutes after hospital arrival
Measured: From 10 minutes after study drug administration to 60-minutes after hospital arrival
Number of participants underwent endotracheal intubation
Number of participants underwent endotracheal intubation at 60 minutes after hospital arrival
Measured: 60 minutes after hospital arrival
Number of participants with severe hypotension
Number of participants with severe hypotension at the time of hospital arrival
Measured: At the time of hospital arrival (up to 1 hour)
Number of participants with severe hypertension
Number of participants with severe hypertension at the time of hospital arrival
Measured: At the time of hospital arrival (up to 1 hour)
Number of participants with severe cardiac arrhythmia
Number of participants with severe cardiac arrhythmia at the time of hospital arrival
Measured: At the time of hospital arrival (up to 1 hour)
Number of participants with emergence reactions
Number of participants with emergence reactions (hallucination, delirium, vivid dreams, blurred/double vision, hypersalivation) following study drug administration till hospital arrival
Measured: At the time of hospital arrival (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start3 Aug 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convulsive Status EPILEPTICUSStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pragmatic, decentralized, pre-consented, event-driven randomized controlled trial. The investigators aim to recruit and pre-randomize up to 668 patients who meet the eligibility criteria. These participants will be randomized to receive either add-on intramuscular ketamine combined with a second dose of midazolam, or a second dose of midazolam alone, in the event of convulsive status epilepticus (CSE) that is not terminated by an initial dose of midazolam. The sample size has been calculated to ensure that approximately 100 participants will experience the qualifying event (CSE not responding to first-dose midazolam) and receive the assigned study medications, anticipating that 50 will receive ketamine plus second-dose midazolam and 50 will receive the second dose of midazolam alone.
- Masking
- None (open label)
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelkreem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095842
- Sponsor's protocol ID
- Soh-Med-25-7-4PD
- Acronym
- PEAK-SEEK
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unidentified individual participant data will be available to qualifying researchers upon a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Add-on Ketamine With Second-dose Midazolam for Prehospital Treatment of Epileptic Children With Status Epilepticus
- ClinicalTrials.gov ID
- NCT07095842
- Acronym / sponsor ID
- PEAK-SEEK / Soh-Med-25-7-4PD
- Conditions
- Convulsive Status EPILEPTICUS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 3 Aug 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus.
Detailed description
Status epilepticus (SE) is the most prevalent neurological emergency in children. Benzodiazepines (BDZs) remain the first-line anti-seizure medication (ASM) for SE, but about one-third of seizures are not controlled by BDZs. Moreover, second-line ASMs (levetiracetam, valproate, phenytoin) fail to terminate BDZ-refractory SE in 50% of cases. Such prolonged SE is linked with progressive brain damage and an increased risk of epilepsy, irreversible neurodevelopmental sequelae, and mortality. Accordingly, early control of SE is critical for enhancing clinical outcomes.
A possible strategy for rapid control of SE is using early ASM combination. Ketamine seems a promising choice for such a combination. Ketamine acts to antagonize N-methyl-D-aspartate (NMDA) receptors, which become increasingly upregulated and trafficked to the synaptic membrane during ongoing seizure activity. Numerous observational studies have demonstrated that administration of ketamine is associated with termination or attenuation of refractory SE (RSE) and super-refractory SE (SRSE). Furthermore, the recently published Ket-Mid study showed that the ketamine-midazolam combination was more effective than midazolam alone in the initial treatment of pediatric generalized CSE. However, the Ket-Mid study also highlighted a significant delay in hospital arrival and administration of first-line ASM, by a median of 34 minutes, reflecting delayed access to emergency care due to socioeconomic challenges, geographic barriers, and limited prehospital emergency medical services. Such a challenge also applies to resource-limited settings, where treatment delays are more common. Notably, a review by Gaínza-Lein et al. of 15 studies involving 2212 patients with SE reported average times to ASM treatment and hospital arrival of 42.4 and 56 minutes, respectively. Such delay to the administration of ASM is associated with increased resistance to BZDs, longer SE, and increased risk of complications. Accordingly, there is a growing interest in the early use of ASM for prehospital treatment of SE.
Ketamine has been used in prehospital setting for a long time, mainly for sedation and analgesia purposes with a high safety profile. Multiple observational studies have reported the efficacy of ketamine in the pre-hospital emergency treatment of BZD-refractory status epilepticus. However, this was not adequately investigated in clinical trials.
The present study (Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids, PEAK-SEEK) aims to investigate the efficacy of adding ketamine to second-dose midazolam vs. second-dose midazolam alone as ASM for prehospital treatment of epileptic children with convulsive status epilepticus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic, decentralized, pre-consented, event-driven randomized controlled trial. The investigators aim to recruit and pre-randomize up to 668 patients who meet the eligibility criteria. These participants will be randomized to receive either add-on intramuscular ketamine combined with a second dose of midazolam, or a second dose of midazolam alone, in the event of convulsive status epilepticus (CSE) that is not terminated by an initial dose of midazolam. The sample size has been calculated to ensure that approximately 100 participants will experience the qualifying event (CSE not responding to first-dose midazolam) and receive the assigned study medications, anticipating that 50 will receive ketamine plus second-dose midazolam and 50 will receive the second dose of midazolam alone.
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Midazolam | Experimental | Drug: Ketamine, Drug: Midazolam |
| Midazolam | Active comparator | Drug: Midazolam |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 2 to 16 years.
- Established diagnosis of epilepsy of at least 1 year duration.
- History of at least 1 episode of convulsive status epilepticus in the preceding 12 months.
Key exclusion criteria (5 listed)
- Failure to obtain informed consent.
- Known allergies or contraindications to ketamine.
- Known contraindications to intramuscular injection.
- Presence of another family member included in the same trial.
- Having subsequent events (only the index event will be included).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineIntramuscular ketamine 2 mg/kg (max 90 mg) | Drug | Ketamine + Midazolam |
| MidazolamIntramuscular midazolam 0.2 mg/kg (max 10 mg) | Drug | Ketamine + Midazolam, Midazolam |
Primary outcome
Number of participants with cessation of seizures at the time of hospital arrival
Time frame: At the time of hospital arrival (up to 1 hour)
Number of participants with cessation of clinically evident seizures at the time of hospital arrival
7 secondary outcomes
Number of participants with sustained cessation of seizures
Time frame: From 10 minutes after study drug administration to 60-minutes after hospital arrival
Number of participants with recurrence of seizures
Time frame: From 10 minutes after study drug administration to 60-minutes after hospital arrival
Number of participants underwent endotracheal intubation
Time frame: 60 minutes after hospital arrival
Number of participants with severe hypotension
Time frame: At the time of hospital arrival (up to 1 hour)
Number of participants with severe hypertension
Time frame: At the time of hospital arrival (up to 1 hour)
Number of participants with severe cardiac arrhythmia
Time frame: At the time of hospital arrival (up to 1 hour)
Number of participants with emergence reactions
Time frame: At the time of hospital arrival (up to 1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No. Unidentified individual participant data will be available to qualifying researchers upon a reasonable request
Related trials for Convulsive Status EPILEPTICUS
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Non-Convulsive Status Epilepticus
Not yet recruitingPhase 3
Targeted Hypothermia Versus Targeted Normothermia After Convulsive Refractory Status Epilepticus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine and Midazolam in people with Convulsive Status EPILEPTICUS, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsayed Abdelkreem (1114232126 ext. +20, d.elsayedmohammed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with cessation of seizures at the time of hospital arrival (time frame: At the time of hospital arrival (up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.