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临床试验/NCT00305058
NCT00305058已完成2 期

A Randomized Clinical Trial Comparing Intravenous Morphine and Intravenous Hydromorphone in the Treatment of Adult ED Patients With Moderate to Severe Pain

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
194
试验地点
1
主要终点
Change in Pain Intensity

研究概览

简要总结

The purpose of this research study is to determine which opiate pain medication (morphine or hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients presenting to the emergency department.

详细描述

Pain is cited as the most frequent reason for visit to emergency departments (EDs) . It can be estimated from the National Hospital Ambulatory Medical Care Survey, an annual survey of a representative sample of visits to US EDs, that there are 17 million visits per year to US EDs for specific complaints of pain, 29 million visits including "back symptoms" and "injuries not otherwise specified" as well as specific mentions of pain. However it is widely acknowledged that pain is seriously under-treated in the ED as well as in other health care settings. The concern regarding under-treatment is reflected in new standards for pain management developed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requiring assessment of pain at triage in the ED and referring to pain measurement as the "fifth vital sign".

Proper pain management is a tremendous challenge to ED physicians as pain is not only a noxious experience but also a symptom of injury and disease that needs to be understood and appropriately treated. Further complicating pain management is the large interpersonal variability in pain perception and expression reflecting cultural, contextual, and individual differences between people. Reasons for under-treating pain include concern over side effects of opioids, perception of pain complaints as possible drug-seeking behavior, under-staffing, concern that analgesics will mask symptoms, delay early diagnosis, treatment, and contribute to risks of tolerance and dependence in vulnerable patients.

The elderly represent a group of patients who may experience pain differently from the non-elderly patient. This growing population has been significantly underrepresented in pain-related studies. Some studies have shown that the elderly are at risk for "oligoanalgesia" and receive inadequate doses of pain medication.

Morphine has long been considered the gold standard in pain control. Hydromorphone is another powerful opiate that has been used extensively for the management of post-operative pain and morphine-resistant cancer-related pain. A recent Cochrane review on the use of hydromorphone found 32 studies that focused on acute pain. Of these 32 studies, only 9 involved intravenous forms of hydromorphone. Of these 8 studies, 5 involved patient controlled analgesia, and only 1 study compared intravenous (IV) hydromorphone to IV morphine. The Cochrane review concludes that there are gaps in the understanding of the efficacy and potency of hydromorphone. Only 1 study of hydromorphone in the ED could be located and this compared IV hydromorphone versus IV meperidine in patients with ureteral colic. Although this study showed hydromorphone was superior at all time periods and had fewer side effects, the study used fixed doses of hydromorphone (1mg) and meperidine (50mg).

It has been the clinical experience of some ED physicians that hydromorphone may be a better opiate in patients presenting to the ED with acute pain. Hydromorphone is also the opiate that is usually given if morphine does not adequately control a patient's pain in the ED.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 65 years
  • Pain with onset within 7 days
  • ED attending physician's judgment that patient's pain warrants use of parenteral opioids
  • Normal mental status

排除标准

  • Prior use of methadone
  • Use of other opioids or tramadol within past seven days
  • Prior adverse reaction to morphine or hydromorphone
  • Chronic pain syndrome
  • Alcohol intoxication
  • Systolic Blood Pressure <90 mm Hg
  • Use of monoamine oxidase (MAO) inhibitors in past 30 days
  • Elderly patients with a capnometry reading of greater than 46

研究组 & 干预措施

Hydromorphone

Experimental

0.0075 mg/kg IV hydromorphone

干预措施: Hydromorphone (Drug)

Morphine

Active Comparator

0.05 mg/kg IV morphine

干预措施: Morphine (Drug)

结局指标

主要结局

Change in Pain Intensity

时间窗: Baseline to 30 minutes after medication infused

Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused

次要结局

  • Number of Participants With a Change in Pain Score(Baseline to 30 minutes after medication infused)
  • Number of Participants With Pain Relief(30 minutes after medication infused)
  • Number of Participants Satisfied With Pain Medication(30 minutes after medication infused)

研究者

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

Andrew Chang, MD

Assistant Professor

Montefiore Medical Center

研究点 (1)

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