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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT03151863
• Date of registration: 31/03/2017
• Prospective Registration: Yes
• Primary sponsor: Walid HABRE
• Public title: Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care INDEX
• Scientific title: Intranasal Dexmedetomidine for Procedural Pain Management in Elderly Adults in Palliative Care Setting: a Cross Over, Superiority, Double-blind, Controlled and Randomized Clinical Trial
• Date of first enrolment: November 14, 2018
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03151863
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Walid Habre, MD, PhD
• Affiliation: University of Geneva

Key inclusion & exclusion 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.



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Analgesia

Anxiolysis

Sedation

Intervention(s)

Drug: Opioids

Drug: Dexmedetomidine

Drug: Placebo

Primary Outcome(s)

Total score for ECPA over 5 [Time Frame: Minutes 35]

Secondary Outcome(s)

Time to come back to the initial sedation state [Time Frame: Hour 2]

Pain evolution [Time Frame: Minutes 90]

Time to reach a level of sedation of mOAA less or equal to 4 before the care [Time Frame: Minutes 45]

anxiety [Time Frame: Minutes 35]

Secondary ID(s)

INDEX_NDR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors