Comparison of Ionsys and Routine Care With Morphine IV (Intravenous) PCA in the Management of Early Post-operative Mobilisation, Ability to Mobilise and in Time to Fitness For Discharge
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 108
- 试验地点
- 7
- 主要终点
- Participant's Evaluation of Mean Ability to Mobilize After Surgery
研究概览
简要总结
The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective major abdominal or orthopedic (pertaining to the bones) surgery.
详细描述
This is a randomized (study drug assigned by chance), multicentre (when more than one hospital or medical school team work on a medical research study), open-label (participants and physicians are told which treatment the participants are receiving), active-controlled (experimental treatment is compared to a standard treatment), parallel group study (a study comparing the response in two or more groups of participants receiving different treatments). The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. Eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 24 hours after an elective spine or elective orthopedic surgery) will be randomly assigned to receive either Ionsys or morphine IV PCA. Participants' safety will be monitored.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Participant's Evaluation of Mean Ability to Mobilize After Surgery
时间窗: Hour 72 or early study withdrawal
The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).
次要结局
- Pain Intensity Numerical Rating Scale (NRS)(Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours))
- Nurse Ease of Care (EOC) Questionnaire Score(When participant was fit for discharge (FFD) (assessed up to 91 hours))
- Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control(Hour 72 or early study withdrawal)
- Time to Fit For Discharge (FFD)(When participant was FFD (assessed up to 91 hours))
- Number of Participants Who Require Rescue Medication(Baseline up to Hour 3)
- Number of Participants Who Require Concomitant Antiemetic Medication(Baseline up to end of study treatment (Hour 72))
- Number of Participants Who Require Concomitant Non-opioid Analgesics(Baseline up to end of study treatment (Hour 72))