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The Management of Postoperative Craniotomy Pain in Pediatric Patients

2017年12月7日 更新者:Johns Hopkins University

The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study

The purpose of this prospective, clinical observational trial is to assess the incidence of pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics, methods of analgesic delivery, and patient/parent satisfaction in patients undergoing craniotomy surgery at three major children's hospitals (Boston Children's Hospital, Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the United States.

研究概览

研究类型

观察性的

注册 (实际的)

81

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

    • Maryland
      • Baltimore、Maryland、美国、21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Children's Hospital Boston
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia

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

不超过 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

200 patients who are scheduled for craniotomy surgery under general anesthesia at 3 major children's hospitals will be eligible. Potential patients include those undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Following surgery, patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.

Once daily, a study investigator will make an independent pain assessment using an age appropriate, validated tool (FLACC, Pain Face Scale-Revised, self report on a 0-10 scale). The study investigator will also assess overall quality of life and patient/parent satisfaction using a subset of the NRC Picker satisfaction tool and in adolescents a modified QoR-40 (see below).

描述

Inclusion Criteria:

  • Pediatric patients 0-18 years, who are scheduled to undergo craniotomy surgery for any reason (e.g., brain tumor, epilepsy surgery, craniofacial reconstruction) at either the Boston Children's Hospital, the Children's Hospital of Philadelphia, or the Children's Center of the Johns Hopkins Hospital will be eligible for enrollment.

Exclusion Criteria:

  • Patients who remain intubated after surgery. Additionally, we will exclude patients who are allergic to opioids or who have a history of substance abuse

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

队列和干预

团体/队列
Hopkins
Pediatric patients (0-18 yo) who are scheduled for craniotomy surgery under general anesthesia. This will include patients undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.
Childrens Hospital of Philadelphia
Pediatric patients (0-18 yo) who are scheduled for craniotomy surgery under general anesthesia. This will include patients undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.
Childrens Hospital Boston
Pediatric patients (0-18 yo) who are scheduled for craniotomy surgery under general anesthesia. This will include patients undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.

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
pain assessment
大体时间:2 years
To determine the severity of pain and the compliance of physicians and nurses in implementation of institutionally mandated pain assessment tools by chart review. We will also assess which pain assessment tools are in use by health care providers in the 3 participating institutions along with compliance with frequency of pain assessment based on institutional policy.
2 years

次要结果测量

结果测量
措施说明
大体时间
patient/parent satisfaction
大体时间:2 years
To independently determine patient/parent satisfaction and quality of recovery (QOR). Daily, an investigator will use a validated, standardized parental satisfaction tool (a subset of the NRC Picker satisfaction tool) and in adolescents a modified QoR-40.
2 years

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。

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 (实际的)

2011年8月1日

初级完成 (实际的)

2013年6月1日

研究完成 (实际的)

2013年6月1日

研究注册日期

首次提交

2012年4月10日

首先提交符合 QC 标准的

2012年4月11日

首次发布 (估计)

2012年4月12日

研究记录更新

最后更新发布 (实际的)

2017年12月11日

上次提交的符合 QC 标准的更新

2017年12月7日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

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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