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Revista de la Sociedad Española del Dolor

Print version ISSN 1134-8046


TRINIDAD, J. M. et al. An analysis of the effectiveness of sublingual fentanyl citrate in patients with irruptive pain: the Sublime study. Rev. Soc. Esp. Dolor [online]. 2011, vol.18, n.4, pp.207-218. ISSN 1134-8046.

Introduction: the scientific literature suggests that two in every three patients with chronic pain every so often suffer from transient exacerbations because of various causes, some of them predictable and some unexpected. In addition to the suffering they bring about, these episodes represent a relevant issue for patients as they trigger anxiety and add functional disability, which translates into greater difficulties in controlling baseline pain and lower quality of life. In 1990 the term "breakthrough pain" was coined in the United States to define transient cancer pain exacerbations under appropriate pain management with major opioids. In 2002, Sociedad Española de Oncología Médica (SEOM), Sociedad Española de Cuidados Paliativos (SECPAL), and Sociedad Española del Dolor (SED) defined a consensus document wherein the term "dolor irruptivo" (irruptive pain) was adopted to define sudden, transient (usually less than 20-30 minutes), severe (VAS > 7) pain breakouts on the background of stable, persistent pain that remains tolerable (VAS < 5) under primarily major opioids. Overall, three etiologies are recognized for irruptive pain: incidental irruptive pain; idiopathic or spontaneous irruptive pain, and irruptive pain from end-of-dose medication failure. Objectives: the main goal of this work was to retrospectively study the effectiveness of sublingual fentanyl citrate in 180 patients treated for irruptive pain in Andalusian pain units during 1 month. Secondary goals included a description of the clinical indications and epidemiologic features of patients with irruptive pain under sublingual fentanyl citrate; understanding sublingual fentanyl citrate regimens for patients with irruptive pain; and a research of adverse events potentially associated with the use of sublingual fentanyl citrate in patients with irruptive pain. Material and methods: a retrospective, observational study of 180 patients, of whom 173 completed the study. Inclusion criteria (patients had to meet one of the following two) were: IP episodes with VAS > 5 during the last 12-24 hours and/or undesired side effects arising from the current therapy for irruptive pain. Within the primary goal an analysis of the results for each VAS follow-up, the number of irruptive pain events, and pain relief onset was performed. Similarly, an analysis was also performed to compare these variables in the cancer pain group versus the non-cancer pain group, and in the idiopathic pain group versus the incidental pain group. Regarding secondary goals, age, gender, patient profile (adverse effects and irruptive pain episodes), active substance for baseline pain management, percentage of patients taking an additional 100 mcg dose of sublingual fentanyl, fentanyl dose per episode, mean fentanyl dose a day, and adverse effects were also analyzed. Results: mean patient age in the study was 62.8 years; 49% of patients enrolled were women, and 51% were men. Of all patients included 55.6% had non-cancer pain and 44.4% had cancer pain; in 38.3% of patients irruptive pain was idiopathic, in 60% it was incidental, and in 1,7% pain type was unknown. Ninety-seven percent of patients were included because of their having a VAS score above 5, and the remaining 3% had side effects arising from their current therapy for irruptive pain. The efficacy analysis identified a significant decrease in all primary variables (VAS assessment, mean number of irruptive pain episodes, and pain relief onset) from baseline starting at the first follow-up. The between-group analysis (cancer vs. non-cancer pain) recorded no significant differences in primary variables. However, the analysis according to irruptive pain type found that all patients with incidental pain reported a milder decrease in VAS, a higher number of irruptive pain episodes, and later-onset relief. Within secondary goals, the analysis of adverse effects noted no significant differences in the prevalence of side effects between the cancer and non-cancer pain groups. Nevertheless, a significantly higher incidence of nausea, vomiting, and somnolence was found in the idiopathic pain group as compared to the incidental pain group. It was also concluded that satisfaction was comparable among patients (good-excellent = 83.7%) and investigators (good-excellent = 85.5%). Conclusions: analysis results indicate: - The effectiveness of sublingual fentanyl is demonstrated since there is a significant decrease in VAS scores from baseline. - The duration of irruptive pain episodes significantly decreases after sublingual fentanyl therapy onset. - Effectiveness as measured through primary variables (VAS, number of irruptive pain episodes, pain relief onset) was consistent regardless of underlying disease (cancer versus non-cancer). - No significant differences were found in the analysis of fentanyl doses per pain episode according to underlying disease of pain type. - Its safety profile is demonstrated with no differences in the incidence of adverse effects between cancer and non-cancer pain groups.

Keywords : Fentanyl; Irruptive pain; Sublingual.

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