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

Abstract

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. Supplementary Information The online version contains supplementary material available at 10.1007/s40266-023-01027-3.

Intranasal Therapy in Palliative Care

“…In the context of palliative patients, nursing care is very important and is considered one of the strategic factors in improving patient comfort [63]. However, even simple nursing interventions can increase pain intensity and cause procedural breakthrough pain, the incidence of which reaches up to 12-20% [16]. It is very important that in such situations the pain relief or sedation is simple, easy, and convenient for everyone involved in the process [16,31].…”

“…However, even simple nursing interventions can increase pain intensity and cause procedural breakthrough pain, the incidence of which reaches up to 12-20% [16]. It is very important that in such situations the pain relief or sedation is simple, easy, and convenient for everyone involved in the process [16,31]. Intranasal drug delivery seems to fulfil these requirements.…”

“…In the population of palliative patients at the end of life, the convenience of using the drug is particularly important [3]. Taking medications orally is much more convenient for patients than intravenous, intramuscular or subcutaneous administration [16]. However, the ability to bypass the first-pass effect through the gastrointestinal tract and liver gives an advantage to molecules administered intranasally over the oral route [25].…”

“…A limitation of the use of the intranasal route of drug administration is the limited volume of drug that can be administered. The volume of the drug that can be administered into one nostril in adults and children is 1 mL [16] and 0.3 mL [50], respectively. However, some articles indicate that the volume of substance sprayed or dropped into each nostril should not exceed 0.15 mL [2].…”

“…Intranasal administration was studied in the treatment of a wide variety of ailments and diseases, such as depression [6], eating disorders [7], obesity [8], hormonal disorders, treatment of primary brain tumors [9], neurodegenerative processes (Parkinson's disease [7], Alzheimer's disease [10], Huntington's disease [11]), coagulation disorders [12,13], treatment of infections (vaccines [14]), migraine [15], and addictions [4]. There are also reports describing the use of systemic treatment by the intranasal route among palliative care patients [16]. There is a growing demand for alternative methods of drug administration for patients at the end of life [2].…”