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临床试验/NCT01891812
NCT01891812已完成2 期

Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis

Columbia University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2013年11月12日最近更新:
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
5
试验地点
1
主要终点
Pain Score

研究概览

简要总结

Patients who have sickle cell VOC are usually treated with opioids, such as morphine. However, this current way of treating them has not improved the health, medical outcomes, or rates of hospitalizations. In addition, since VOC can happen very frequently over a long period of time, giving opioids over and over again can cause both short-term and long-term problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3 hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine infusions, and is used extensively in France, where almost half of 85 pediatric emergency departments use nitrous oxide to treat children with VOC whose pain did not get better with standard treatment with morphine. However, pain relief which N2O provides in the acute setting has not been well described. Therefore, the purpose of our study is to describe how well N2O can relieve the pain in patients with SCD who present to the emergency department and are experiencing a VOC.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with sickle cell disease
  • Ages 8 to 18, inclusive
  • Present to the pediatric emergency department with VOC and whose pain scores remain greater than or equal to 7/10 on the NRS after initial standard treatment (i.e. IV fluids, morphine and NSAIDs).

排除标准

  • life-threatening illness as determined by attending clinician
  • developmental delay
  • altered level of consciousness
  • any contraindications to receiving N2O
  • foster children and wards of the state

研究组 & 干预措施

Nitrous oxide 50%

Experimental

Nitrous oxide 50% administered for 20 minutes.

干预措施: Nitrous oxide 50% (Drug)

结局指标

主要结局

Pain Score

时间窗: Up to 4 hours

Patient-reported pain score immediately after administration of nitrous oxide. The full range of the pain score is 0 to 10; 0 = no pain, 10 = worst pain.

次要结局

  • Duration of Analgesia(Up to 4 hours)

研究者

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

Daniel S Tsze, MD, MPH

Associate Professor of Pediatrics in Emergency Medicine

Columbia University

研究点 (1)

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