Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging
Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging
研究概览
详细说明
Invasive procedures for diagnosis in children are a routine part of an emergency care department. Most of these procedures are painful and uncomfortable for both the child and for their families, and impossible to be performed without patient immobilization. Thus, procedural sedation is critical to this end. Procedural sedation can be defined as the use of sedatives, analgesics, or dissociative drugs for anxiolysis, analgesia, sedation and motor control during painful procedures.
The increasing demand of pediatric emergency services and, consequently, the performance of procedures that require sedation, made it impossible for universal coverage of anesthesiologists in such procedures. As a result, a wide variety of drugs, sedation techniques and different degrees of effectiveness and adverse effects of sedation, such as irritability and sedation failure are described.
Particularly in children who need CT scan, there is usually no need for venous access for sedation. However, our most used drug, chloral hydrate, was abandoned in most centers outside the country. When administered orally, the drug produces malaise and vomiting, and gastric mucosal irritation, in addition, the rectal absorption is unpredictable. Additionally, in recent years increasing importance has been given to the fact that the drug be related, in vitro, the increased carcinogenicity in mice by cellular structural change, which is leading to the ban of same drug in the United States and in some european countries.
Dexmedetomidine is a highly selective alpha-2 agonist receptors, which has the advantage of mimicking natural sleep, according to electroencephalographic studies, with low incidence of adverse events. Its application as a sedative in pediatric procedures, as well as pre-anesthetic medication, has been increasingly described according to recent studies. The intranasal route has been used with the advantage of avoiding a venous line or intramuscular injection, with good results; however, it hasn't been described yet in children undergoing CT scans.
Thus, this work is justified to describe, in a pioneering way, the use of intranasal dexmedetomidine for sedation for CT, documenting its efficacy and safety in a specific cohort of patients sedated for this purpose.
研究类型
注册 (预期的)
联系人和位置
学习地点
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SP
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Sao Paulo、SP、巴西、05508000
- 招聘中
- University Hospital, University of Sao Paulo
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接触:
- Alfredo Gilio, MD, PhD
- 电话号码:919409 +55 11 30919200
- 邮箱:aegilio@uol.com.br
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首席研究员:
- Eduardo Mekitarian Filho, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department
Exclusion Criteria:
- Glasgow coma scale < 13
- Epistaxis or suspected base skull fracture
- Use of contrast or need for an IV line before sedation
- Uncontrolled gastroesophageal reflux or vomiting
- Current (or within past 3 months) history of apnea of prematurity requiring an apnea monitor
- Acute, unstable respiratory disease
- Unstable cardiac status
- Craniofacial anomaly
- Medication use: digoxin
- Moya Moya Disease
- New onset stroke
- American Society of Anesthesiologists physical status ≥3
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Dexmedetomidine
All children undergoing
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging
大体时间:Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
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Main outcome for this research is to know if IN dexmedetomidine is effective for adequate sedation in children undergoing CT scannings.
This will be reported as percentage of failed sedations, if they occur.
Failed sedations will be defined if after a initial 2.5 mcg/kg dose along with another 0.5 mcg/kg dose after 15 minutes, the child does not sedate.
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Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Safety of IN dexmedetomidine for pediatric CT imaging
大体时间:At admission and every 5 minutes after sedation
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Patients will be fully monitored every five minutes after IN dexmedetomidine administration, with heart rate, respiratory rate, non-invasive blood pressure and pulse oximetry.
Any adverse events will be reported.
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At admission and every 5 minutes after sedation
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合作者和调查者
调查人员
- 研究主任:Keira Mason, MD、Boston Children's Hospital, Harvard Medical School
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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