[Breakthrough pain treatment with sublingual fentanyl in patients with chronic cutaneous ulcers]

Abstract

Objective: The aim of the study was to assess the efficacy and safety of opioids in the management of pain in those patients with chronic cutaneous ulcers and breakthrough/incidental pain.

Material and method: An open-label, multicentre, prospective, uncontrolled study was conducted in the pain and ulcer units of 5 hospitals across the Comunidad Valenciana. Eligibility criteria were baseline pain 4 in the visual analogue scale or breakthrough procedural pain 4. Exclusion criteria were cognitive impairment, opioid intolerance, or patient refusal to provide informed consent. The protocol scheduled 5 controls: baseline (enrolment), 15 days, one month, 2 months, and 3 months. The main outcome measure of the study was the visual analogue scale score during rest, movement and procedures. Opioids were administered for release of the baseline pain, and sublingual fentanyl for breakthrough pain.

Results: A total of 32 patients (86.5%) completed the study. Baseline pain achieved a mean improvement of 3.6 visual analogue scale points (SD 2.3), movement pain improved by 3.9 points (SD 2.5) and procedural pain improved by 4.5 points (SD 2.8), and the mean pain intensity improvement was statistically significant from the first control and at all controls thereafter (P<.001). Nausea was reported by 14 patients (43.8%), drowsiness and constipation by 7 (21.9%), itching by 5 (15.6%), and one (3.1%) reported vomiting.

Conclusions: Structured assessment of pain is a key concept in the management of patient with chronic cutaneous ulcers. The results of this study suggest that opioid therapy provides clinically significant pain relief with few adverse effects.

Keywords: Analgesics opioids; Analgésicos opioides; Breakthrough pain; Chronic pain; Dolor crónico; Dolor irruptivo; Fentanilo; Fentanyl; Manejo del dolor; Pain management; Skin ulcer; Úlcera cutánea.