Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- The primary outcome measure will be the sum of 7 pain intensity differences (SPID) computed from 8 observations of pain during the 8-hour period.
研究概览
简要总结
The overall aim of this study is to find out whether Hylenex recombinant (for short, Hylenex) in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids in hospice patients. Specifically, this study proposes to compare the level of self-reported pain in hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid) over the initial 8 hours of opioid infusion with and without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.
详细描述
As of January 2009, 58 patients were recruited to the study as study subjects. Target goals for the study is to recruit 88 subjects with full and accurate information with about 44 patients in the Hylenex group and another group of subjects in the control group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant, non-lactating adults 18+ years enrolled in inpatient facilities at LifePath or Good Shepherd Hospice
- •Ability to provide informed consent; Patient has decision-making capacity (SPMSQ score 6+)
- •Ability to provide numerical report on pain level on pain scale
- •English-speaking
- •Pain not satisfactorily controlled with current meds -oral, topical, or rectal; Pain level greater than 3 at admission on a 0-10 scale
- •Able to self-administer bolus dose or ask someone to hit bolus button
- •Estimated life expectancy of 3 days or more
- •Patients appropriate for continuous SC infusion with either morphine or hydromorphone.
排除标准
- •History of allergy or hypersensitivity to Hylenex or any components of product
- •Patients on infusion therapy for pain management up to 14 days prior to entering inpatient facilities.
- •Patients who are actively dying identified by any of the following physical signs and symptoms:
- •non-communicative or unresponsiveness; b) confusion/disorientation about time, place, and people; c) significant chest congestion with gurgling sounds; d) restless and repetitive motions; e) little or no food or fluid intake; f) minimal urine output and g) different breathing pattern, i.e., shallow rapid breaths with period of no breathing.
研究组 & 干预措施
A
干预措施: Hylenex recombinant , morphine, saline (Drug)
B
干预措施: Hylenex recombinant , morphine, saline (Drug)
B
干预措施: Saline (Other)
结局指标
主要结局
The primary outcome measure will be the sum of 7 pain intensity differences (SPID) computed from 8 observations of pain during the 8-hour period.
时间窗: For a period of 8 hours from start to finish
次要结局
- The secondary outcome measure will be the sum of distress level differences (SDLD), sum of relief level differences (SRLD), and sum of bolus attempts (SBAM) made during the same 8-hour period.(For a period of 8 hours from start to finish)
- The mean number of bolus attempts made over the 8-hour period between experimental and control groups.(The bolus attempts will be observed for the 8-hour period from start to finish.)