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临床试验/NCT06271096
NCT06271096已完成早期 1 期

Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children

Arooj Khan1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Fits Controlled

研究概览

简要总结

IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures

详细描述

A seizure or convulsion is a time-limited, paroxysmal, change in motor activity and or behavior that results from electrical activity in the brain that is abnormal.1 The emergency department of a hospital is usually the place where children with seizures receive first treatment and medical support. Seizures make up about 1% of all emergency department visits for pediatric patients, and at least 5% of pediatric patients will have a seizure by the time they are 16 years old. Children younger than one year of age are commonly affected by new and unprovoked seizures.2 Seizures can result in continuous muscular activity, which leads to tissue breakdown because of anaerobic metabolism as well as decreasing oxygen and glucose to the brain causing brain ischemia and neuronal death. So, the seizures must be controlled rapidly to decrease the systemic as well as brain damage.3,4 First-line anticonvulsants for the treatment of acute seizures are benzodiazepines. Diazepam is frequently used for the treatment of seizures because it can be delivered either intravenously or rectally. It is lipophilic so does not have proper intramuscular absorption. Precious time is spent in getting intravenous access or per rectal catheterization. While midazolam, is a lipid-soluble benzodiazepine, rapidly absorbed after intramuscular (IM) injection.5,6 For managing seizure, the drug should be sufficiently potent to allow small volume and an administration that is quick, easy, and safe with quick action and little monitoring.7 Intramuscular midazolam meets these criteria and may be useful for the treatment of seizures, but more trials are needed to see the safety and efficacy of this therapy in the pediatric population.8 A major chunk of the seizures may occur out of the hospital. For the parents its frightening to see their kid in fits. Usually these parents immediately take their child to the nearby hospital or clinic. But it's not possible for all the parents, because in many areas health facilities are not present. Hence these patients are at increased risk for sustaining post ictal brain damage. There is a long-awaited wish that how to prevent this brain damage. A lot of options are tried nowadays and also in the past, like rectal diazepam, sublingual midazolam, but unfortunately most such options are not without risks.

The objective of this study was to compare the time taken by intramuscular midazolam to stop the seizure as compared to intravenous diazepam in emergency cases in the pediatric age group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients presented to the pediatric emergency, with all types of seizures, aged 3 months to 5 years.

排除标准

  • Children who already had intravenous access.
  • Children who had signs of clinical heart failure like tachycardia, tachypnea, and hepatomegaly.
  • Children who had any severe systemic disease like renal disorder, liver disorder, and Beta Thalassemia major.
  • Known allergy to midazolam or diazepam
  • Children who had hypoglycemia as the known cause of seizure
  • Children with other known causes of fits, like hypocalcemia, CKD, Hypoparathyroidism, Renal Tubular Acidosis

研究组 & 干预措施

Group A IM-Midazolam

Experimental

Group A received IM midazolam at a dose of 0.2 mg/kg gently injected into the vastus lateralis muscle

干预措施: Intra muscular Midazolam (Drug)

Group B IV Diazepam

Experimental

Patients in group B were cannulated in the dorsum of the hand or foot, or the great saphenous vein at the ankle first and then administered diazepam at a dose of 0.2mg/kg

干预措施: Intravascular Diazepam (Drug)

结局指标

主要结局

Fits Controlled

时间窗: 300 seconds

Treatment was considered successful if seizures stopped within 300 seconds of administering the drug. If seizures were not controlled within 300 seconds, Treatment failures were marked. other anticonvulsants were tried.

次要结局

未报告次要终点

研究者

发起方
Arooj Khan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arooj Khan

Assistant Professor Muhammad Kashif

Khyber Teaching Hospital

研究点 (1)

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