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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Capital
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Islamabad, Capital, 파키스탄, 44000
- PAF Hospital Islamabad
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Buccal Midazolam
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).
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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).
|
|
활성 비교기: Intramuscular Midazolam
In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml)
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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).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cessation of seizues
기간: 5 minutes after drug administered
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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.
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5 minutes after drug administered
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공동 작업자 및 조사자
수사관
- 연구 의자: Prof Dr Asma Shabbir, MBBS,FCPS(Paediatrics),MHPE, Pakistan Air Force Hospital Islamabad
간행물 및 유용한 링크
일반 간행물
- 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/
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ERC/15
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Midazolam에 대한 임상 시험
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Al Jedaani Hospital완전한
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Jiangsu Hansoh Pharmaceutical Co., Ltd.모병
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University Hospital, Grenoble모병