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

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.

Timeline

Start

2022-01-15

Primary completion

2022-05-14

Completion

2022-06-14

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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/

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