- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07626255
Comparing the Outcome of Buccal Midazolam and Intramuscular Midazolam in Children Presenting With Seizures.
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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
6. 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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
Capital
-
Islamabad, Capital, Paquistão, 44000
- PAF Hospital Islamabad
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Children with cardiac arrest or hemodynamic instability at presentation, head trauma or drowning.
- Diagnosed cases of metabolic disorders, CKD.
- Diagnosed case of raised ICP.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Buccal Midazolam
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).
|
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).
|
|
Comparador Ativo: Intramuscular Midazolam
In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml)
|
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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cessation of seizues
Prazo: 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.
|
5 minutes after drug administered
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE, Pakistan Air Force Hospital Islamabad
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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/
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ERC/15
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .