Seizure Disorder Generalized Tonic ClonicPhase 4NCT07626255
Comparing the Outcome of Buccal Midazolam and Intramuscular Midazolam in Children Presenting With Seizures.
A Phase 4 study testing Midazolam in people with Seizure Disorder Generalized Tonic Clonic, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
Trial summary
The goal of this clinical trial(Quasi Experimental) is to compare efficacy of oral midazolam over intra-muscular Midazolam in children suffering from seizures. The main question it aims to answer is: Does Buccal midazolam has a better efficacy as compared to intramuscular midazolam in children presenting with… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Seizure Disorder Generalized Tonic Clonic
- What is being tested?
- Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2022to 14 Jun 2022
- Phase
- Phase 4
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 6 months to 12 years, both genders, presenting with seizures (as per operational definition)
- Children with Seizure disorder, Febrile fits, Meningitis without raised intracranial pressure.
Who cannot join
- Children with cardiac arrest or hemodynamic instability at presentation, head trauma or drowning.
- Diagnosed cases of metabolic disorders, CKD.
- Diagnosed case of raised ICP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Buccal Midazolam Versus Inter-muscular Midazolam in Control of Seizures
The goal of this clinical trial(Quasi Experimental) is to compare efficacy of oral midazolam over intra-muscular Midazolam in children suffering from seizures. The main question it aims to answer is:
Does Buccal midazolam has a better efficacy as compared to intramuscular midazolam in children presenting with seizures?
There will be two groups determined by randomisation and then one will be given buccal midazolam and other will will be administered IM Midazolam .The out come will be determined by the determining the cessation of seizures within 5 minutes duration achieved by administration of drug.
Read the detailed description
- Introduction: Generalised convulsive seizure is a serious and potentially life threatening medical emergency that requires prompt intervention. Administration of buccal midazolam is an efficient and easier method for control of seizures without the need for intravenous cannulation expertise or intramuscular injections.
- Objectives: To compare the outcome of buccal midazolam versus intramuscular midazolam in children presenting with seizures.
- Study Design: It is RCT
- Settings: Pediatric Medicine Department, PAF hospital, Islamabad
- Study Duration:
15th January 2022 to 14th July 2022
- Materials \& Methods: A total of 90 patients of both genders, 6 months to 12 years of age, presenting with seizures were included. Children with cardiac arrest or haemodynamic instability at presentation, head trauma or drowning, metabolic disorders, CKD were excluded.
All the patients were divided into two groups by lottery method.
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).
In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml). They were followed till resolution of symptoms. If seizure resolved within 5 minutes, then success was labelled.
- Being tested
- Midazolam
- Keywords
- Acute seizure, Buccal midazolam, Intramuscular midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml).
| Study group | Role | What they receive |
|---|---|---|
| Buccal Midazolam | Active comparator | In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). Receives: Drug: Midazolam |
| Intramuscular Midazolam | Active comparator | In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml) Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of seizues
Cessation of seizures within 5 minutes duration achieved by administration of drug will be determined as success. Based on this cut off value for time we obtained dichotomous results i.e, Successful or Not Successful.
- Seizures resolving > 5 minutes considered unsuccessful.
- Seizures resolving < 5 minutes considered successful.
Measured: 5 minutes after drug administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Jan 2022
- Primary completion14 May 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Seizure Disorder Generalized Tonic ClonicStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Tayyab Qureshi, Pakistan Air Force (PAF) Hospital Islamabad
- Investigators
- Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE, Study chair, Pakistan Air Force Hospital Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626255
- Sponsor's protocol ID
- ERC/15
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It's due to confidentiality purpose.Stats will be shared on demand only.
Publications
Scott RC, Besag FM, Neville BG. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: a randomised trial. Lancet. 1999 Feb 20;353(9153):623-6. doi: 10.1016/S0140-6736(98)06425-3.
PubMed 10030327Ashrafi MR, Khosroshahi N, Karimi P, Malamiri RA, Bavarian B, Zarch AV, Mirzaei M, Kompani F. Efficacy and usability of buccal midazolam in controlling acute prolonged convulsive seizures in children. Eur J Paediatr Neurol. 2010 Sep;14(5):434-8. doi: 10.1016/j.ejpn.2010.05.009. Epub 2010 Jun 15.
PubMed 20554464Alansari 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 32387007Nakken KO, Lossius MI. Buccal midazolam or rectal diazepam for treatment of residential adult patients with serial seizures or status epilepticus. Acta Neurol Scand. 2011 Aug;124(2):99-103. doi: 10.1111/j.1600-0404.2010.01474.x. Epub 2011 Jan 6.
PubMed 21208198Mpimbaza A, Ndeezi G, Staedke S, Rosenthal PJ, Byarugaba J. Comparison of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children: a randomized clinical trial. Pediatrics. 2008 Jan;121(1):e58-64. doi: 10.1542/peds.2007-0930.
PubMed 18166545McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, Martland T, Berry K, Collier J, Smith S, Choonara I. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet. 2005 Jul 16-22;366(9481):205-10. doi: 10.1016/S0140-6736(05)66909-7.
PubMed 16023510Javadzadeh M, Sheibani K, Hashemieh M, Saneifard H. Intranasal midazolam compared with intravenous diazepam in patients suffering from acute seizure: a randomized clinical trial. Iran J Pediatr. 2012 Mar;22(1):1-8.
PubMed 23056852Kutlu NO, Dogrul M, Yakinci C, Soylu H. Buccal midazolam for treatment of prolonged seizures in children. Brain Dev. 2003 Jun;25(4):275-8. doi: 10.1016/s0387-7604(02)00230-9.
PubMed 12767460Talukdar B, Chakrabarty B. Efficacy of buccal midazolam compared to intravenous diazepam in controlling convulsions in children: a randomized controlled trial. Brain Dev. 2009 Nov;31(10):744-9. doi: 10.1016/j.braindev.2008.11.006. Epub 2008 Dec 27.
PubMed 19114297Trinka E, Cock H, Hesdorffer D, Rossetti AO, Scheffer IE, Shinnar S, Shorvon S, Lowenstein DH. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia. 2015 Oct;56(10):1515-23. doi: 10.1111/epi.13121. Epub 2015 Sep 4.
PubMed 26336950Riva A, Iapadre G, Grasso EA, Balagura G, Striano P, Verrotti A. Intramuscular Midazolam for treatment of Status Epilepticus. Expert Opin Pharmacother. 2021 Jan;22(1):37-44. doi: 10.1080/14656566.2020.1810236. Epub 2020 Aug 25.
PubMed 32840150Rey E, Treluyer JM, Pons G. Pharmacokinetic optimization of benzodiazepine therapy for acute seizures. Focus on delivery routes. Clin Pharmacokinet. 1999 Jun;36(6):409-24. doi: 10.2165/00003088-199936060-00003.
PubMed 10427466Lingamchetty TN, Hosseini SA, Patel P, Saadabadi A. Midazolam. 2025 Jul 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537321/
PubMed 30726006
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Buccal Midazolam Versus Inter-muscular Midazolam in Control of Seizures
- ClinicalTrials.gov ID
- NCT07626255
- Acronym / sponsor ID
- ERC/15
- Keywords
- Acute seizure, Buccal midazolam, Intramuscular midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pakistan Air Force (PAF) Hospital IslamabadUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 14 May 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 4 Jun 2026 (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 clinical trial(Quasi Experimental) is to compare efficacy of oral midazolam over intra-muscular Midazolam in children suffering from seizures. The main question it aims to answer is:
Does Buccal midazolam has a better efficacy as compared to intramuscular midazolam in children presenting with seizures?
There will be two groups determined by randomisation and then one will be given buccal midazolam and other will will be administered IM Midazolam .The out come will be determined by the determining the cessation of seizures within 5 minutes duration achieved by administration of drug.
Detailed description
- Introduction: Generalised convulsive seizure is a serious and potentially life threatening medical emergency that requires prompt intervention. Administration of buccal midazolam is an efficient and easier method for control of seizures without the need for intravenous cannulation expertise or intramuscular injections.
- Objectives: To compare the outcome of buccal midazolam versus intramuscular midazolam in children presenting with seizures.
- Study Design: It is RCT
- Settings: Pediatric Medicine Department, PAF hospital, Islamabad
- Study Duration:
15th January 2022 to 14th July 2022
- Materials \& Methods: A total of 90 patients of both genders, 6 months to 12 years of age, presenting with seizures were included. Children with cardiac arrest or haemodynamic instability at presentation, head trauma or drowning, metabolic disorders, CKD were excluded.
All the patients were divided into two groups by lottery method.
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).
In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml). They were followed till resolution of symptoms. If seizure resolved within 5 minutes, then success was labelled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal Midazolam | Active comparator | Drug: MidazolamIn group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). |
| Intramuscular Midazolam | Active comparator | Drug: MidazolamIn group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml) |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of age 6 months to 12 years, both genders, presenting with seizures (as per operational definition)
- Children with Seizure disorder, Febrile fits, Meningitis without raised intracranial pressure.
Key exclusion criteria (3 listed)
- Children with cardiac arrest or hemodynamic instability at presentation, head trauma or drowning.
- Diagnosed cases of metabolic disorders, CKD.
- Diagnosed case of raised ICP.
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 |
|---|---|---|
| MidazolamIn group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml). | Drug | Buccal Midazolam, Intramuscular Midazolam |
Primary outcome
Cessation of seizues
Time frame: 5 minutes after drug administered
Cessation of seizures within 5 minutes duration achieved by administration of drug will be determined as success. Based on this cut off value for time we obtained dichotomous results i.e, Successful or Not Successful. 1. Seizures resolving > 5 minutes considered unsuccessful. 2. Seizures resolving < 5 minutes considered successful.
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 15 Jun 2026.
- Background: PubMed 10030327Scott RC, Besag FM, Neville BG. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: a randomised trial. Lancet. 1999 Feb 20;353(9153):623-6. doi: 10.1016/S0140-6736(98)06425-3.
- Background: PubMed 20554464Ashrafi MR, Khosroshahi N, Karimi P, Malamiri RA, Bavarian B, Zarch AV, Mirzaei M, Kompani F. Efficacy and usability of buccal midazolam in controlling acute prolonged convulsive seizures in children. Eur J Paediatr Neurol. 2010 Sep;14(5):434-8. doi: 10.1016/j.ejpn.2010.05.009. Epub 2010 Jun 15.
- 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.
- Background: PubMed 21208198Nakken KO, Lossius MI. Buccal midazolam or rectal diazepam for treatment of residential adult patients with serial seizures or status epilepticus. Acta Neurol Scand. 2011 Aug;124(2):99-103. doi: 10.1111/j.1600-0404.2010.01474.x. Epub 2011 Jan 6.
- Background: PubMed 18166545Mpimbaza A, Ndeezi G, Staedke S, Rosenthal PJ, Byarugaba J. Comparison of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children: a randomized clinical trial. Pediatrics. 2008 Jan;121(1):e58-64. doi: 10.1542/peds.2007-0930.
- Background: PubMed 16023510McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, Martland T, Berry K, Collier J, Smith S, Choonara I. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet. 2005 Jul 16-22;366(9481):205-10. doi: 10.1016/S0140-6736(05)66909-7.
- Background: PubMed 23056852Javadzadeh M, Sheibani K, Hashemieh M, Saneifard H. Intranasal midazolam compared with intravenous diazepam in patients suffering from acute seizure: a randomized clinical trial. Iran J Pediatr. 2012 Mar;22(1):1-8.
- Background: PubMed 12767460Kutlu NO, Dogrul M, Yakinci C, Soylu H. Buccal midazolam for treatment of prolonged seizures in children. Brain Dev. 2003 Jun;25(4):275-8. doi: 10.1016/s0387-7604(02)00230-9.
- Background: PubMed 19114297Talukdar B, Chakrabarty B. Efficacy of buccal midazolam compared to intravenous diazepam in controlling convulsions in children: a randomized controlled trial. Brain Dev. 2009 Nov;31(10):744-9. doi: 10.1016/j.braindev.2008.11.006. Epub 2008 Dec 27.
- Background: PubMed 26336950Trinka E, Cock H, Hesdorffer D, Rossetti AO, Scheffer IE, Shinnar S, Shorvon S, Lowenstein DH. A definition and classification of status epilepticus--Report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia. 2015 Oct;56(10):1515-23. doi: 10.1111/epi.13121. Epub 2015 Sep 4.
- Background: PubMed 32840150Riva A, Iapadre G, Grasso EA, Balagura G, Striano P, Verrotti A. Intramuscular Midazolam for treatment of Status Epilepticus. Expert Opin Pharmacother. 2021 Jan;22(1):37-44. doi: 10.1080/14656566.2020.1810236. Epub 2020 Aug 25.
- Background: PubMed 10427466Rey E, Treluyer JM, Pons G. Pharmacokinetic optimization of benzodiazepine therapy for acute seizures. Focus on delivery routes. Clin Pharmacokinet. 1999 Jun;36(6):409-24. doi: 10.2165/00003088-199936060-00003.
- Individual participant dataSharing planned: No. It's due to confidentiality purpose.Stats will be shared on demand only.
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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.
Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE study chair
Pakistan Air Force Hospital Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam in people with Seizure Disorder Generalized Tonic Clonic, run by Pakistan Air Force (PAF) Hospital Islamabad 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 2 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 15 Jun 2026. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cessation of seizues (time frame: 5 minutes after drug administered). 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 NCT07626255, which also lists 13 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 15 Jun 2026.