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临床试验/NCT01380197
NCT01380197已完成3 期

Choosing Opioid Management for Pain and Analyzing ACS Rates Equally

Children's Healthcare of Atlanta1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年5月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Acute Chest Syndrome

研究概览

简要总结

The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects.

The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
  • 6 years old and < 19 years old
  • Normal baseline chest radiograph
  • Normal renal and hepatic function within the previous 12 months

排除标准

  • Previous patient participation in this clinical trial
  • Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
  • Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
  • Any patient with documented allergy to either study drug
  • Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:
  • Hepatic dysfunction (3x ALT),
  • Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults),
  • Pulmonary Hypertension (TRJ >3.0),
  • Cardiac dysfunction.
  • Any patient with symptoms of an acute stroke.
  • Any patient known or suspected to be pregnant.
  • Any patient with priapism
  • The patient or guardian who will not give consent or assent to be randomized.

研究组 & 干预措施

Randomizing particiipants to Morphine

Active Comparator

Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis

干预措施: Morphine (Drug)

Randomization to Nubain

Active Comparator

Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients

干预措施: Nubain (Drug)

结局指标

主要结局

Acute Chest Syndrome

时间窗: 3 days

Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray

次要结局

  • Number of Participants Who Experienced Pain Relief(2 days)

研究者

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

Saadia Khizer

Iris Buchanan MD

Children's Healthcare of Atlanta

研究点 (1)

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