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

NCT03151863 | Terminated Phase 3

• 1 other identifier: INDEX_NDR
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dexmedetomidine; Opioids; Palliative Care; Elderly people; Nursing care; Analgesia; Sedation; Anxiolysis; Intranasal

Outcome Measures

Primary Outcomes (1)

• Total score for ECPA over 5

  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.

  Minutes 35

Secondary Outcomes (4)

• 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

Other Outcomes (2)

• Bradycardia

  Hours 3 minutes 30

• Hypoxemia

  Hours 3 minutes 30

Study Arms (2)

Opioids, placebo

ACTIVE COMPARATOR

One single dose of subcutaneous opioids and intranasal placebo (NaCl0.9%).

Drug: Opioids; Drug: Placebo

Placebo, Dexmedetomidine

EXPERIMENTAL

One single dose of subcutaneous placebo (NaCl0.9%) and intranasal Dexmedetomidine 1.25ug/Kg

Drug: Dexmedetomidine; Drug: Placebo

Interventions

Opioids DRUG

The usual opioid treatment used for nursing care

Also known as: Opioid prescribed to the patient on routine basis

Opioids, placebo

Dexmedetomidine DRUG

Dexmedetomidine is provided intranasally

Also known as: Dexdor

Placebo, Dexmedetomidine

Placebo DRUG

Normal saline is either given subcutaneously or intranasally

Also known as: Normal saline

Opioids, placebo; Placebo, Dexmedetomidine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walid HABRE: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1206, Switzerland

Location

Related Publications (1)

• Dieudonne Rahm N, Zaccaria I, Gil Wey B, Pautex S, Habre W, Elia N. Intranasal Dexmedetomidine for Pain Management in Older Patients: A Cross-Over, Randomized, Double-Blinded, Active-Controlled Trial. Drugs Aging. 2023 Jun;40(6):527-538. doi: 10.1007/s40266-023-01027-3. Epub 2023 May 11.

  PMID: 37170043 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics, Opioid; Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Walid Habre, MD, PhD

  University of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: This two-sided, superiority, cross-over trial is based on a clinically relevant reduction (≥20%) of primary outcome (ECPA pain score \>5) with the Dexmedetomidine treatment versus standard active control (opioids). It requires a sample size of 52 patients for a paired analysis with an intra-patient correlation of 50%. Type I error: 0.05 and type II error: 0.20. 25% of drop-out are expected. In consequence, 66 patients are required for the study.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: May 12, 2017
• Study Start: November 14, 2018
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

CH (1)