SeizuresEarly Phase 1NCT06271096
Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children
A Early Phase 1 study testing Intra muscular Midazolam and Intravascular Diazepam in people with Seizures, run by Arooj Khan at 1 site in Pakistan.
Trial summary
IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Seizures
- What is being tested?
- Intra muscular Midazolam and Intravascular Diazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2019to 1 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presented to the pediatric emergency, with all types of seizures, aged 3 months to 5 years.
Who cannot join
- 1. Children who already had intravenous access. 2. Children who had signs of clinical heart failure like tachycardia, tachypnea, and hepatomegaly.
- 3. Children who had any severe systemic disease like renal disorder, liver disorder, and Beta Thalassemia major.
- 4. Known allergy to midazolam or diazepam 5. Children who had hypoglycemia as the known cause of seizure 6. Children with other known causes of fits, like hypocalcemia, CKD, Hypoparathyroidism, Renal Tubular Acidosis
Trial locations and contacts
1 site in 1 country.
About this study
IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures
Read the detailed description
A seizure or convulsion is a time-limited, paroxysmal, change in motor activity and or behavior that results from electrical activity in the brain that is abnormal.1 The emergency department of a hospital is usually the place where children with seizures receive first treatment and medical support. Seizures make up about 1% of all emergency department visits for pediatric patients, and at least 5% of pediatric patients will have a seizure by the time they are 16 years old. Children younger than one year of age are commonly affected by new and unprovoked seizures.2 Seizures can result in continuous muscular activity, which leads to tissue breakdown because of anaerobic metabolism as well as decreasing oxygen and glucose to the brain causing brain ischemia and neuronal death. So, the seizures must be controlled rapidly to decrease the systemic as well as brain damage.3,4 First-line anticonvulsants for the treatment of acute seizures are benzodiazepines. Diazepam is frequently used for the treatment of seizures because it can be delivered either intravenously or rectally. It is lipophilic so does not have proper intramuscular absorption. Precious time is spent in getting intravenous access or per rectal catheterization. While midazolam, is a lipid-soluble benzodiazepine, rapidly absorbed after intramuscular (IM) injection.5,6 For managing seizure, the drug should be sufficiently potent to allow small volume and an administration that is quick, easy, and safe with quick action and little monitoring.7 Intramuscular midazolam meets these criteria and may be useful for the treatment of seizures, but more trials are needed to see the safety and efficacy of this therapy in the pediatric population.8 A major chunk of the seizures may occur out of the hospital. For the parents its frightening to see their kid in fits. Usually these parents immediately take their child to the nearby hospital or clinic. But it's not possible for all the parents, because in many areas health facilities are not present. Hence these patients are at increased risk for sustaining post ictal brain damage. There is a long-awaited wish that how to prevent this brain damage. A lot of options are tried nowadays and also in the past, like rectal diazepam, sublingual midazolam, but unfortunately most such options are not without risks.
The objective of this study was to compare the time taken by intramuscular midazolam to stop the seizure as compared to intravenous diazepam in emergency cases in the pediatric age group.
- Conditions
- Seizures
- Being tested
- Intra muscular Midazolam, Intravascular Diazepam
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra muscular MidazolamDrug
ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED
Intravascular DiazepamDrug
ROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED
| Study group | Role | What they receive |
|---|---|---|
| Group A IM-Midazolam | Experimental | Group A received IM midazolam at a dose of 0.2 mg/kg gently injected into the vastus lateralis muscle Receives: Drug: Intra muscular Midazolam |
| Group B IV Diazepam | Experimental | Patients in group B were cannulated in the dorsum of the hand or foot, or the great saphenous vein at the ankle first and then administered diazepam at a dose of 0.2mg/kg Receives: Drug: Intravascular Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fits Controlled
Treatment was considered successful if seizures stopped within 300 seconds of administering the drug. If seizures were not controlled within 300 seconds, Treatment failures were marked. other anticonvulsants were tried.
Measured: 300 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Nov 2019
- Primary completion1 Nov 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arooj Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arooj Khan, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271096
- Sponsor's protocol ID
- 638/ADR/KMC
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hosseini F, Nikkhah A, Afkhami Goli M. Serum Zinc Level in Children with Febrile Seizure. Iran J Child Neurol. 2020 Winter;14(1):43-47.
PubMed 32021627Santillanes G, Luc Q. Emergency department management of seizures in pediatric patients. Pediatr Emerg Med Pract. 2015 Mar;12(3):1-25; quiz 26-7.
PubMed 25799698Scott RC. What are the effects of prolonged seizures in the brain? Epileptic Disord. 2014 Oct;16 Spec No 1(Spec No 1):S6-11. doi: 10.1684/epd.2014.0689.
PubMed 25323416Zilberter Y, Zilberter M. The vicious circle of hypometabolism in neurodegenerative diseases: Ways and mechanisms of metabolic correction. J Neurosci Res. 2017 Nov;95(11):2217-2235. doi: 10.1002/jnr.24064. Epub 2017 May 2.
PubMed 28463438Kienitz R, Kay L, Beuchat I, Gelhard S, von Brauchitsch S, Mann C, Lucaciu A, Schafer JH, Siebenbrodt K, Zollner JP, Schubert-Bast S, Rosenow F, Strzelczyk A, Willems LM. Benzodiazepines in the Management of Seizures and Status Epilepticus: A Review of Routes of Delivery, Pharmacokinetics, Efficacy, and Tolerability. CNS Drugs. 2022 Sep;36(9):951-975. doi: 10.1007/s40263-022-00940-2. Epub 2022 Aug 16.
PubMed 35971024Humphries LK, Eiland LS. Treatment of acute seizures: is intranasal midazolam a viable option? J Pediatr Pharmacol Ther. 2013 Apr;18(2):79-87. doi: 10.5863/1551-6776-18.2.79.
PubMed 23798902Agarwal SK, Cloyd JC. Development of benzodiazepines for out-of-hospital management of seizure emergencies. Neurol Clin Pract. 2015 Feb;5(1):80-85. doi: 10.1212/CPJ.0000000000000099.
PubMed 29443201Alansari K, Barkat M, Mohamed AH, Al Jawala SA, Othman SA. Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial. Pediatr Neurol. 2020 Aug;109:28-34. doi: 10.1016/j.pediatrneurol.2020.03.011. Epub 2020 Mar 16.
PubMed 32387007
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children
- ClinicalTrials.gov ID
- NCT06271096
- Acronym / sponsor ID
- 638/ADR/KMC
- Conditions
- Seizures
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Arooj KhanUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Feb 2024 (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.
IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures
Detailed description
A seizure or convulsion is a time-limited, paroxysmal, change in motor activity and or behavior that results from electrical activity in the brain that is abnormal.1 The emergency department of a hospital is usually the place where children with seizures receive first treatment and medical support. Seizures make up about 1% of all emergency department visits for pediatric patients, and at least 5% of pediatric patients will have a seizure by the time they are 16 years old. Children younger than one year of age are commonly affected by new and unprovoked seizures.2 Seizures can result in continuous muscular activity, which leads to tissue breakdown because of anaerobic metabolism as well as decreasing oxygen and glucose to the brain causing brain ischemia and neuronal death. So, the seizures must be controlled rapidly to decrease the systemic as well as brain damage.3,4 First-line anticonvulsants for the treatment of acute seizures are benzodiazepines. Diazepam is frequently used for the treatment of seizures because it can be delivered either intravenously or rectally. It is lipophilic so does not have proper intramuscular absorption. Precious time is spent in getting intravenous access or per rectal catheterization. While midazolam, is a lipid-soluble benzodiazepine, rapidly absorbed after intramuscular (IM) injection.5,6 For managing seizure, the drug should be sufficiently potent to allow small volume and an administration that is quick, easy, and safe with quick action and little monitoring.7 Intramuscular midazolam meets these criteria and may be useful for the treatment of seizures, but more trials are needed to see the safety and efficacy of this therapy in the pediatric population.8 A major chunk of the seizures may occur out of the hospital. For the parents its frightening to see their kid in fits. Usually these parents immediately take their child to the nearby hospital or clinic. But it's not possible for all the parents, because in many areas health facilities are not present. Hence these patients are at increased risk for sustaining post ictal brain damage. There is a long-awaited wish that how to prevent this brain damage. A lot of options are tried nowadays and also in the past, like rectal diazepam, sublingual midazolam, but unfortunately most such options are not without risks.
The objective of this study was to compare the time taken by intramuscular midazolam to stop the seizure as compared to intravenous diazepam in emergency cases in the pediatric age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review
| Arm | Type | Receives |
|---|---|---|
| Group A IM-Midazolam | Experimental | Drug: Intra muscular MidazolamGroup A received IM midazolam at a dose of 0.2 mg/kg gently injected into the vastus lateralis muscle |
| Group B IV Diazepam | Experimental | Drug: Intravascular DiazepamPatients in group B were cannulated in the dorsum of the hand or foot, or the great saphenous vein at the ankle first and then administered diazepam at a dose of 0.2mg/kg |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients presented to the pediatric emergency, with all types of seizures, aged 3 months to 5 years.
Key exclusion criteria (3 listed)
- 1. Children who already had intravenous access. 2. Children who had signs of clinical heart failure like tachycardia, tachypnea, and hepatomegaly.
- 3. Children who had any severe systemic disease like renal disorder, liver disorder, and Beta Thalassemia major.
- 4. Known allergy to midazolam or diazepam 5. Children who had hypoglycemia as the known cause of seizure 6. Children with other known causes of fits, like hypocalcemia, CKD, Hypoparathyroidism, Renal Tubular Acidosis
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 |
|---|---|---|
| Intra muscular MidazolamROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED | Drug | Group A IM-Midazolam |
| Intravascular DiazepamROUTE OF ADMINISTRATION AND DRUG EFFICACY COMPARED | Drug | Group B IV Diazepam |
Primary outcome
Fits Controlled
Time frame: 300 seconds
Treatment was considered successful if seizures stopped within 300 seconds of administering the drug. If seizures were not controlled within 300 seconds, Treatment failures were marked. other anticonvulsants were tried.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 32021627Hosseini F, Nikkhah A, Afkhami Goli M. Serum Zinc Level in Children with Febrile Seizure. Iran J Child Neurol. 2020 Winter;14(1):43-47.
- Background: PubMed 25799698Santillanes G, Luc Q. Emergency department management of seizures in pediatric patients. Pediatr Emerg Med Pract. 2015 Mar;12(3):1-25; quiz 26-7.
- Background: PubMed 25323416Scott RC. What are the effects of prolonged seizures in the brain? Epileptic Disord. 2014 Oct;16 Spec No 1(Spec No 1):S6-11. doi: 10.1684/epd.2014.0689.
- Background: PubMed 28463438Zilberter Y, Zilberter M. The vicious circle of hypometabolism in neurodegenerative diseases: Ways and mechanisms of metabolic correction. J Neurosci Res. 2017 Nov;95(11):2217-2235. doi: 10.1002/jnr.24064. Epub 2017 May 2.
- Background: PubMed 35971024Kienitz R, Kay L, Beuchat I, Gelhard S, von Brauchitsch S, Mann C, Lucaciu A, Schafer JH, Siebenbrodt K, Zollner JP, Schubert-Bast S, Rosenow F, Strzelczyk A, Willems LM. Benzodiazepines in the Management of Seizures and Status Epilepticus: A Review of Routes of Delivery, Pharmacokinetics, Efficacy, and Tolerability. CNS Drugs. 2022 Sep;36(9):951-975. doi: 10.1007/s40263-022-00940-2. Epub 2022 Aug 16.
- Background: PubMed 23798902Humphries LK, Eiland LS. Treatment of acute seizures: is intranasal midazolam a viable option? J Pediatr Pharmacol Ther. 2013 Apr;18(2):79-87. doi: 10.5863/1551-6776-18.2.79.
- Background: PubMed 29443201Agarwal SK, Cloyd JC. Development of benzodiazepines for out-of-hospital management of seizure emergencies. Neurol Clin Pract. 2015 Feb;5(1):80-85. doi: 10.1212/CPJ.0000000000000099.
- Background: PubMed 32387007Alansari K, Barkat M, Mohamed AH, Al Jawala SA, Othman SA. Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial. Pediatr Neurol. 2020 Aug;109:28-34. doi: 10.1016/j.pediatrneurol.2020.03.011. Epub 2020 Mar 16.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intra muscular Midazolam and Intravascular Diazepam in people with Seizures, run by Arooj Khan at 1 site in Pakistan.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2024. 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 Pakistan. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fits Controlled (time frame: 300 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06271096, which also lists 8 linked publications.
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 23 Feb 2024.