跳至主要内容
临床试验/NCT05121324
NCT05121324招募中3 期

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Stanford University20 个研究点 分布在 1 个国家目标入组 6,700 人开始时间: 2022年8月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
6,700
试验地点
20
主要终点
Seizing on emergency department arrival

研究概览

简要总结

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children.

PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner.

One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice.

Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings.

If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.

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
Single (Outcomes Assessor)

盲法说明

Neurologists will assess the primary outcome of seizing on emergency department arrival using a rapid response electroencephalogram (RR-EEG) that is applied to the patient's scalp upon arrival. Site-specific identifiers will not be available to the neurologist when reading the RR-EEG, so they will be masked to whether the patient was treated under the conventional or standardized protocol.

Since the participants' parents will likely see how the paramedics select the midazolam dose and may share that with the participant, they will not be masked to the intervention. The paramedics are the care providers, and they will not be masked to the intervention since their medical director must inform them when their seizure treatment protocol switches from the conventional to the standardized protocol. The investigators will not be masked because they will conduct the training of the paramedic trainers at each site between randomization and implementation of the intervention.

入排标准

年龄范围
6 Months 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
  • Under the care of a paramedic; AND
  • Transported by an EMS agency participating in the study

排除标准

  • A prior history of a benzodiazepine allergy; OR
  • Known or presumed pregnancy; OR
  • Severe growth restriction based on the paramedic's subjective assessment

研究组 & 干预措施

Intervention

Experimental

This arm will be exposed to the study intervention: a standardized seizure protocol.

干预措施: Standardized seizure protocol (Drug)

Control

Active Comparator

This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm

干预措施: Conventional seizure protocol (Drug)

结局指标

主要结局

Seizing on emergency department arrival

时间窗: Between arrival to the emergency department and 10 minutes after arrival

Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).

次要结局

  • Respiratory failure(Between paramedic arrival on scene until 30 minutes after emergency department arrival)
  • Time to first midazolam administration(From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manish Shah

Professor

Stanford University

研究点 (20)

Loading locations...

相似试验