Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care (NCT03151863) | Clinical Trial Compass
TerminatedPhase 3
Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care
Stopped: Lack of budget
Switzerland33 participantsStarted 2018-11-14
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Informed consent signed and dated by the patient or a next of kin;
* ≥65 years old patients;
* Admitted in the palliative medicine unit;
* Undergoing, minimum once per day, a nursing care procedure lasting between 15 and 30 minutes causing discomfort (anxiety, pain or both) and therefore requiring the administration of an extra dose of Morphine, Hydromorphone before the nursing care;
* Taking, on a regularly basis, one of the following opioids: Morphine, Hydromorphone, Buprenorphine, Fentanyl.
Exclusion criteria
* Known hypersensitivity or allergy to Dexmedetomidine or Midazolam;
* Fentanyl extra dose medication before nursing cares;
* Weight \> 80Kg;
* Psychomotor agitation;
* Known bronchial aspiration risks : ileus, vomiting, nausea, clinically relevant gastrooesophageal reflux;
* Known respiratory distress risk: recent need to be ventilated in Intensive Care Unit setting (\<7 days), recent change or degradation of the respiratory status (\<2 days) with apneas or tachypnea (\>20/min), or known sleep apnea without non invasive ventilation; contraindication for nasal drug administration (ex. nasal tumour obstruction);
* Known cardiac risk : recent cardiac decompensation (\<7 days) ; known life threatening or severe heart rate disorders ; bradycardia \<60 bpm or known level II or III atrioventricular block without pacemaker ; hypotension with systolic blood pressure less or equal to 100 mmHg; Digoxine treatment;
* Known acute cerebrovascular disease or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.