Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care

• Status: Terminated
• Trial end date: 2021-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walid HABRE
• Treatments: Analgesics, Opioid; Dexmedetomidine

Criteria

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 recent stroke (<1month);

• Already enrolled in another study or previous enrolment into the current study;

• Participation in another study with investigational drug within the 30 days preceding and during the present study.