此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

The Effect of Pain Medication in Children With Acute Abdominal Pain and Its Implication Over the Surgeon's Decision

The Effect of Opiate Administration in Children With Acute Abdominal Pain and Peritoneal Signs on the Decision for Surgical Intervention

Surgeons are the individuals who will operate on a patient if it is determined to be necessary after they present with abdominal pain. For that reason, the investigators want to study if giving a medicine (morphine) to children presenting to the ED with abdominal pain will alleviate pain without changing the patient's physical exam and the subsequent surgeon's decision.

The investigators also will record any side effects of morphine, any associated surgical complications, and to identify the ultimate diagnosis.

研究概览

地位

撤销

条件

详细说明

Unfortunately, the current standard of care obviates the use of pain medication in children with acute abdominal pain while waiting for the attending pediatric surgeon to perform their examination and determine if the patient requires operative intervention. This process can sometimes be protracted.

This practice occurs currently because of the concerns that analgesia may alter physical findings, interfere with the diagnosis, and delay definitive surgical intervention resulting in increased morbidity. This point of view has been challenged recently.

We designed this study taking into account the paramount importance of the pediatric surgeon's role in determining the need for operative intervention in the ultimate management of patient's presenting with acute abdominal pain and signs and symptoms of peritonitis.

Our primary objective is to demonstrate that the administration of intravenous morphine will alleviate pain in children presenting to the Emergency Department (ED) with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.

Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis.

This is a prospective, randomized double-blind, placebo-controlled clinical that will be conducted in the ED at Children's Medical Center of Dallas. Children aged 1 to 18 years with acute abdominal pain of ≤ 3 days duration, a moderate to severe pain score, and the presence of peritoneal signs will be eligible. Patients will be randomized to receive either 0.1mg/kg of intravenous morphine (maximum 10 mg) or an equal volume of placebo (0.9% saline).

An ED physician will obtain clinical data, determine the pain score, write a presumptive diagnosis and place an order for the study medication. A surgical physician will also obtain clinical data and write his/her disposition. This evaluation will be repeated at 30-120 minutes after administration of the study medication by the ED and surgical physicians.

Each subject will be monitored for 2 weeks after enrollment for follow-up.

研究类型

介入性

阶段

  • 不适用

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

    • Texas
      • Dallas、Texas、美国、75235
        • Children's Medical Center at Dallas

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年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Children aged 1 to18 years of age who present with acute abdominal pain and signs of peritoneal irritation of less than 5 days duration.
  • Pain scores from moderate to severe
  • Need for intravenous access and require surgical consultation.

Exclusion Criteria:

  • Pregnancy
  • Chronic pain (defined as pain of more than two weeks' duration). 3. Constipation (Bowel movement less than 3imes/week, hard, small, or difficult to eliminate)
  • Prior abdominal surgery or traumatic abdominal pain.
  • History of gastritis, peptic ulcer disease, gastro esophageal reflux disease.
  • Chronic illnesses associated with pain such as Ulcerative colitis, Crohn's disease, sickle cell disease or altered perception to pain (autism, spina bifida, altered mental status).
  • Previous use of morphine sulfate or other narcotic/medication known to alter pain
  • Perception or mental status six hours prior to presentation in the ED.
  • Prior allergy or anaphylaxis to morphine.
  • Acute respiratory distress, hypotension (less than 5thpercentile for age).
  • Renal, pancreatic or biliary disease

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:安慰剂
生理盐水
Morphine Sulfate group: If weight is <50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given
其他名称:
  • Astramorph,Avinza,DepoDur,Duramorph,Infumorph,Kadian
实验性的:Morphine
Morphine Sulfate: If weight is <50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given.
Morphine Sulfate group: If weight is <50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given
其他名称:
  • Astramorph,Avinza,DepoDur,Duramorph,Infumorph,Kadian

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To demonstrate that IV morphine will alleviate pain in children presenting to the Emergency Department with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.
大体时间:2 Hours post-medication
2 Hours post-medication

次要结果测量

结果测量
大体时间
Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis.
大体时间:2 weeks
2 weeks

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

  • 首席研究员:Mercedes M Uribe, MD、UT Southwestern Medical Center

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

2008年12月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2010年12月1日

研究注册日期

首次提交

2009年2月6日

首先提交符合 QC 标准的

2009年2月9日

首次发布 (估计)

2009年2月10日

研究记录更新

最后更新发布 (实际的)

2020年6月25日

上次提交的符合 QC 标准的更新

2020年6月23日

最后验证

2020年6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.

订阅