Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care Setting: a Cross Over, Superiority, Double-blind, Controlled and Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Total score for ECPA over 5
研究概览
简要总结
Dexmedetomidine is allowed in Switzerland for intravenous (IV) medication in the intensive care unit in the adult patient. Its active molecule, Dexmedetomidine (Dex), is a selective and powerful α2-Adrenoreceptors (AR) agonist that shows the following complementary properties: anxiolytic, sedative and analgesic. Moreover, it displays interesting cardiovascular, respiratory and neuropsychic safety and tolerance profiles.
There is increasing number of promising studies for the use of intranasal (IN) Dex in pediatric sedation due to its non-invasive nature, its efficiency and its rare secondary effects. However, there is currently no information in the literature on the use of IN Dex in elderly multi-medicated patients in palliative care.
In this end-of-life population, pain is controlled with administration of opioids. Procedures, such as nursing cares, can generate pain and anxiety to the patient. Preventive analgesia, subcutaneous (SC) opioids, is administered before the care. However, most of the time, this additional dose fails to relieve the patient from his pain. In SPdol observational study, 42% daily hygiene and comfort nursing care remained painful despite the administration of a preventive analgesia.
IN Dex seems to be a good candidate for non-invasive analgesia and sedation in patients admitted in palliative care before the nursing procedure.
In this study, the investigators compare the efficiency of IN Dex to the regular extradose of SC opioids for analgesia before daily nursing care on elderly patients in the palliative care unit.
The study design is a cross over, two-sided, superiority, double-blind, placebo-controlled and randomized clinical trial.
详细描述
Although necessary for patient wellbeing, nursing care procedures potentially produce discomfort, that should be addressed before the procedures begin. In palliative care setting, daily procedures include mobilisation, hygiene care, wound dressing changes, etc. Non-invasive and simple nursing care procedures may cause anxiety and pain that can lead to a refusal of care or an increased distress. The data on procedural pain prevalence are almost only available in pediatrics and are scarce in palliative care and geriatric population. However, the SPdol french study, conducted on elderly people with palliative situations, showed that 85% of procedural pain was related to daily hygiene and comfort care. Results indicate also that in 42%, this type of care remained painful despite preventive pharmacologic measures as opioids administration. Intensity of procedural pain associated with daily and hygiene care is expected to be moderate to severe and not related to presence or absence of pain before initiation of the procedure but to bad prognostic.
In the context of chronic health problems, comfort management pharmacological interventions to achieve analgesia, slight or conscious sedation during nursing care procedures must ideally combine the following properties:
- Rapid recovery and excellent cardiovascular and respiratory security profile;
- Be administrable in the regular place of care of the patient;
- Minimal requirement for medical surveillance in terms of time, equipment and staff;
- Reproducible inset and outset of the analgesic and anxiolytic effect;
- Easy to titrate;
- Convenient, little or non-invasive and administration route as painless as possible.
Dexmedetomidine is allowed in Switzerland for intravenous (IV) medication in the intensive care unit in the adult patient. It is indicated to obtain a level of sedation no deeper than that allowing a response to a verbal stimulus. Its active molecule, Dexmedetomidine (Dex) is a selective and powerful agonist of α2-adrenoreceptors (AR). This drug has come to be of growing interest in anesthesia and sedation field these last years in literature. Its pharmacological actions on the central nervous system consist in sedative, anesthetic, anxiolytic, analgesic action with good cardiovascular, respiratory and neuropsychic tolerance profile. The main possible secondary effect with IV Dex is bradycardia, due to decreased circulating epinephrine and norepinephrine levels observed with this drug.
Intranasal (IN) administration is an easy-to-use and more efficient alternative than placebo or other sedatives (Midazolam, Ketamine, Chloral) for the sedation of sensitive or less collaborative populations as children and young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The nurse administers to the patient both subcutaneous and intranasal dose, however, one of the two is a placebo. The subcutaneous placebo and the subcutaneous opioids have the same packaging. Similar procedure is done for the intranasal compounds.
Neither medical staff nor patient knows which analgesia is administered before this nursing care.
入排标准
- 年龄范围
- 65 Years 至 —(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
研究组 & 干预措施
Opioids, placebo
One single dose of subcutaneous opioids and intranasal placebo (NaCl0.9%).
干预措施: Opioids (Drug)
Opioids, placebo
One single dose of subcutaneous opioids and intranasal placebo (NaCl0.9%).
干预措施: Placebo (Drug)
Placebo, Dexmedetomidine
One single dose of subcutaneous placebo (NaCl0.9%) and intranasal Dexmedetomidine 1.25ug/Kg
干预措施: Dexmedetomidine (Drug)
Placebo, Dexmedetomidine
One single dose of subcutaneous placebo (NaCl0.9%) and intranasal Dexmedetomidine 1.25ug/Kg
干预措施: Placebo (Drug)
结局指标
主要结局
Total score for ECPA over 5
时间窗: Minutes 35
To assess the pain of the patient, a nurse will use the ECPA scale (Elderly Pain Caring Assessment). This is a validated tool to assess pain and anxiety intensity with 8 items based on the behaviour of the non-communicating elder person. The scale is divided in two: the first part is used for the pain assessment before the care while the second part assesses the pain during the care. The minimum score is 0. The maximum score is 32. One to five minutes are needed to do the evaluation depending on the experience of the observer. The pain is assessed 5 minutes before the care and then continuously during the care. When the total score between "before" and "during the care" exceeds 5, the patient is considered as having pain.
次要结局
- Time to reach a level of sedation of mOAA less or equal to 4 before the care(Minutes 45)
- Time to come back to the initial sedation state(Hour 2)
- anxiety(Minutes 35)
- Pain evolution(Minutes 90)
研究者
Walid HABRE
Associate Professor, PhD
University Hospital, Geneva
