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临床试验/NCT01851720
NCT01851720终止2 期

Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012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
终止
入组人数
1
试验地点
1
主要终点
Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).

研究概览

简要总结

Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18-75
  • Glasgow Coma Scale (GCS) 13 or greater
  • Hunt and Hess grade I, II conditions
  • Admitted within 2 days of initial SAH event >6/10 pain on presentation

排除标准

  • Head trauma within the past 30 days
  • Need for craniotomy
  • h/o obstructive sleep apnea or respiratory disease
  • h/o opioid tolerance
  • evidence of vasospasm
  • h/o liver disease

研究组 & 干预措施

Control group / Standard of Care

Active Comparator
  • IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
  • (Bolus dose can be titrated up in 25 mcg increments if necessary)
  • Maximum dose of 100 mcg/hr

干预措施: Standard IV fentanyl bolus (Drug)

Low dose IV fentanyl PCA

Active Comparator
  • Initially: 10 mcg demand dose every 12 minutes
  • No initial bolus and no continuous infusion
  • Demand dose increased 10 mcg every 12 minutes if necessary
  • Maximum dose of 100 mcg/hr

干预措施: Low dose fentanyl PCA (Drug)

结局指标

主要结局

Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).

时间窗: 4 days

Pain score 0-10. 0 represented no pain and 10 worst pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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