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

NCT03151863 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-07-28

No results posted yet for this study

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.

Conditions

  • Analgesia
  • Sedation
  • Anxiolysis

Interventions

DRUG

Opioids

The usual opioid treatment used for nursing care

DRUG

Dexmedetomidine

Dexmedetomidine is provided intranasally

DRUG

Placebo

Normal saline is either given subcutaneously or intranasally

Sponsors & Collaborators

  • Walid HABRE

    lead OTHER

Principal Investigators

  • Walid Habre, MD, PhD · University of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2021-06-08
Completion
2021-06-08

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151863 on ClinicalTrials.gov