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Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

2013年7月11日 更新者:Eduardo Mekitarian Filho、University of Sao Paulo

Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging

This study has the objective to determine if intranasal dexmedetomidine, a sedative, is suitable for pediatric sedation in children undergoing tomographic scans.

研究概览

地位

未知

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

观察性的

注册 (预期的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • SP
      • Sao Paulo、SP、巴西、05508000
        • 招聘中
        • University Hospital, University of Sao Paulo
        • 接触:
          • Alfredo Gilio, MD, PhD
          • 电话号码:919409 +55 11 30919200
          • 邮箱:aegilio@uol.com.br
        • 首席研究员:
          • Eduardo Mekitarian Filho, MD, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1个月 至 15年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The University Hospital of University of Sao Paulo is a secondary teaching hospital. The Pediatric Emergency Department has over 6,000 consultations per month, mainly in children without underlying diseases. Respiratory diseases are the leading causes of hospital admission. During the study period, any children presented to the emergency department with indication for a CT scanning will be recruited for IN dexmedetomidine, respecting the exclusion criteria displayed below.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Dexmedetomidine
All children undergoing
其他名称:
  • Precedex(品牌名称)

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
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).
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.
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).

次要结果测量

结果测量
措施说明
大体时间
Safety of IN dexmedetomidine for pediatric CT imaging
大体时间:At admission and every 5 minutes after sedation
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.
At admission and every 5 minutes after sedation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (预期的)

2013年12月1日

研究完成 (预期的)

2014年1月1日

研究注册日期

首次提交

2013年7月9日

首先提交符合 QC 标准的

2013年7月11日

首次发布 (估计)

2013年7月16日

研究记录更新

最后更新发布 (估计)

2013年7月16日

上次提交的符合 QC 标准的更新

2013年7月11日

最后验证

2013年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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