Global Assessment of Treatment With IONSYS and Its Handling by Patients, Doctors and Nursing Staff in the Management of Acute Moderate to Severe Post-Surgery Pain in Hospitalised Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 174
- 主要终点
- Percentage of Participants With Global Assessment of Pain at Hour 24
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) including the comprehensibility and usefulness of the accompanying information material.
详细描述
This is an open label (all people know the identity of the intervention), single arm, and multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate safety and efficacy of the fentanyl-ITS for management of acute moderate to severe pain in post-operative participants' who have undergone elective surgery (surgery which could be postponed or not done at all without danger to the participant). The study will consists of 2 phases: screening phase (which comprises of pre-operative and post-operative stages) and an open label treatment phase. The participants will be treated with 40 microgram (mcg) of fentanyl transdermally per on-demand dose; each delivered over 10 minutes for a maximum of 6 doses (240 mcg) per hour for 24 hours and a maximum of 80 doses (3.2 milligram [mg]). Each system will inactivate at 80 doses or 24 hour, whichever occurs first. A new system will be applied every 24 hours unless the participant has used 80 doses in less than 24 hours. Maximum treatment duration of 72 hours is allowed. Participants will be expected to require parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours post-operatively. This study will evaluate participant's, nurse's and physician's assessment of fentanyl-ITS under routine conditions. Participants' safety will be monitored throughout the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with American Society of Anesthesiology (specialty concerned with the study of anesthetics [drug that is used to produce loss of pain sensation] and anesthesia [loss of sensation or feeling]) pre-operative physical status 1, 2 or 3
- •Participants who are expected to remain hospitalized for at least 24 hours post-operatively (after the surgery)
- •Participants, after an elective major surgical procedure (surgery which could be postponed or not done at all without danger to the participant), who are expected to have moderate or severe pain requiring parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours after surgery
- •Participants who are capable of understanding and cooperating with the requirements of the study and operating a transdermal (through the skin) Patients-Controlled Analgesia (PCA; methods of pain relief that may be used with or in place of analgesics [drug used to control pain])
- •Participants with a pain score less than or equal to 4 (moderate pain) out of 10 on a Numerical Rating Scale (NRS), whereas 0 corresponds to no pain and 10 to the strongest imaginable pain at movement of the operated limb or body region, after titration (slow increase in drug dosage, guided by participant's responses) to comfort according to current postoperative procedures
排除标准
- •Participants allergic or hypersensitive (very sensitive) to fentanyl or cetylpyridinium chloride or to skin adhesives
- •Participants who are known or suspected to be strong opioid dependent, or who have a very high a need for strong opioids before entering the study
- •Participants with a history of psychological opioid dependence before the start of the study
- •Participants who are known or suspected to have abused any drug substance or alcohol in the opinion of the investigator
- •Women who are pregnant, breast feeding, or planning to breast feed within 24 hrs of the last dose of study drug.
研究组 & 干预措施
Fentanyl-ITS
干预措施: Fentanyl-ITS (Drug)
结局指标
主要结局
Percentage of Participants With Global Assessment of Pain at Hour 24
时间窗: Hour 24
Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.
次要结局
- Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4(Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72)
- Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72(Baseline, Hour 24, 48 and 72)
- Time Spent Out of the Bed Per Day by the Participant(Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72)
- Time to Mobilization(Baseline, Hours 24, 48 and 72)
- Percentage of Participants With Global Assessment of Pain at Hour 48 and 72(Hours 48 and 72)
- Percentage of Participants With Nursing Staff Global Assessment of Pain(Hours 24, 48 and 72)
- Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization(Hours 24, 48 and 72)
- Comprehensibility of the Information Material (IM): Physician Questionnaire Responses(Hour 72)
- Percentage of Participants With Physician Global Assessment of Pain(Hours 24, 48 and 72)
- Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses(Hour 72)
- Comprehensibility of the Information Material (IM): Participant Questionnaire Responses(Hour 72)
- Post-Operative Phase (PPP33) Quality of Life Questionnaire Score(Hour 72)