Comparing the Outcome of Buccal Midazolam and Intramuscular Midazolam in Children Presenting With Seizures.

NCT07626255 | Completed Phase 4 DMC

• 1 other identifier: ERC/15
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Seizure Disorder Generalized Tonic Clonic

Keywords

Acute seizure; Buccal midazolam; Intramuscular midazolam

Outcome Measures

Primary Outcomes (1)

• Cessation of seizues

  Cessation of seizures within 5 minutes duration achieved by administration of drug will be determined as success

  5 minutes after drug administered

Study Arms (2)

Buccal Midazolam

ACTIVE COMPARATOR

In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).

Drug: Midazolam

Intramuscular Midazolam

ACTIVE COMPARATOR

In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml)

Drug: Midazolam

Interventions

Midazolam DRUG

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).

Buccal Midazolam; Intramuscular Midazolam

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with cardiac arrest or hemodynamic instability at presentation, head trauma or drowning.
• Diagnosed cases of metabolic disorders, CKD.
• Diagnosed case of raised ICP.

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

PAF Hospital Islamabad

Islamabad, Capital, 44000, Pakistan

Location

Related Publications (13)

• 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.

  PMID: 10030327 BACKGROUND

• Ashrafi 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.

  PMID: 20554464 BACKGROUND

• Alansari 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.

  PMID: 32387007 BACKGROUND

• Nakken 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.

  PMID: 21208198 BACKGROUND

• Mpimbaza 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.

  PMID: 18166545 BACKGROUND

• McIntyre 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.

  PMID: 16023510 BACKGROUND

• Javadzadeh 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.

  PMID: 23056852 BACKGROUND

• Kutlu 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.

  PMID: 12767460 BACKGROUND

• Talukdar 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.

  PMID: 19114297 BACKGROUND

• Trinka 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.

  PMID: 26336950 BACKGROUND

• Riva 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.

  PMID: 32840150 BACKGROUND

• Rey 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.

  PMID: 10427466 BACKGROUND

• Lingamchetty 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/

  PMID: 30726006 BACKGROUND

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE

  Pakistan Air Force Hospital Islamabad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: January 15, 2022
• Primary Completion: May 14, 2022
• Study Completion: June 14, 2022
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)