Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects.
研究概览
简要总结
The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.
详细描述
This is a safety clinical trial. This trial is monocentric, open label, non-randomized.
Sixty elderly patients will be enrolled in this study, 30 with bedsore cares and 30 with rehabilitation sessions.
Six bedsore cares or rehabilitation sessions will be assessed for each subject. For each session, patient pain will be evaluated using a visual analogic scale VAS at different times, before session, 5 minutes then 20 minutes after the beginning of the session, and a last VAS 1 hour after the end of the session. During the two first sessions, patients do not receive Pecfent® to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care.
An evaluation of respiratory rate and of the level of sedation will occur at different time : after 5 minutes then 20 minutes of care, at the end of the care session,at half an hour then one hour after the care session.
At the end of sessions,
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
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized geriatric patient requiring care or rehabilitation
- •Patient with pain during treatment or mobilization. (VAS ≥ 4)
- •Written Informed consent
排除标准
- •All unstable fractures
- •Confusion: unable to assess their level of pain using a VAS.
- •Contraindications to PecFent ® (. Hypersensitivity to the active substance or to any of the excipients listed in section Composition Use in patients who had never received treatment for opioid severe respiratory depression or severe obstructive pulmonary disease.)
- •Person under legal protection
研究组 & 干预措施
Intranasal fentanyl
干预措施: intranasal fentanyl (Drug)
结局指标
主要结局
Safety of intranasal fentanyl as measured by the nature and frequency of adverse effects.
时间窗: 5 days after the last intake of fentanyl.
The nature and frequency of adverse effects will be described. The collection of adverse events will be first, with the collection of spontaneous patient complaints from nurses on the other hand, by systematic screening with the patient. Monitoring of respiratory rate and level of sedation will also be set up.
次要结局
- Fentanyl impact on the goals of care as measured by a caregiver satisfaction scale.(At the end of session of care or rehabilitation (on average at 1 hour).)
- Impact of PecFent® on patient feelings during care or rehabilitation sessions as measured by a verbal descriptor scale(At the end of Session of care or rehabilitation (on average at 1 hour).)
- Nurse or physiotherapist satisfaction regarding use of PecFent® as measured by a verbal descriptor scale(1 hour after the last intake of fentanyl)
- Effectiveness of intranasal fentanyl in procedural pain using a VAS (Visual Analogic Scale) of pain.(Evolution of the level of pain (VAS) since the beginning of care until one hour after the end of session (on average at 2 hours).)