Intranasal Dexmedetomidine for Pain Management in Older Patients: A Cross-Over, Randomized, Double-Blinded, Active-Controlled Trial.

BACKGROUND: Daily care procedures provoke breakthrough pain and anxiety in palliative situations. Dexmedetomidine may be an alternative to opioids during nursing procedures for older patients. OBJECTIVE: We aimed to compare the efficacy of intranasal dexmedetomidine with subcutaneous opioids on the intensity of pain and anxiety during comfort management procedures. METHODS: We conducted a randomized, active-controlled, double-blind, crossover trial (NCT03151863). Patients aged ≥ 65 years were randomized to receive, 45 min before nursing care, either intranasal dexmedetomidine together with subcutaneous placebo or intranasal placebo together with a subcutaneous opioid. Each of these two interventions were administered in a cross-over design and spaced out over a 24- or 48-h period. The primary outcome was the number of patients with an Elderly Caring Pain Assessment score > 5. Secondary outcomes included pain, sedation score, and vital signs. RESULTS: Because of difficult recruitment, the trial was interrupted after the inclusion of 24 patients. Three patients withdrew after randomization, leaving 21 patients undergoing 42 complete sessions for descriptive analyses. Of the 21 patients, 12 (57.1%) were women, and their median age was 84 years, interquartile range (75-87 years). Nine (42.9%) patients presented an Elderly Caring Pain Assessment score > 5 when receiving subcutaneous opioids, and seven (33.3%) with intranasal dexmedetomidine. Hypoxemia occurred in a single patient receiving subcutaneous opioids. No episode of bradycardia was observed. CONCLUSIONS: Intranasal dexmedetomidine is feasible in elderly patients and may be an alternative to opioids to ensure comfort during nursing care. Future studies are needed to confirm the efficacy and safety of this procedure.