Beyond the traditional definition of breakthrough pain: An observational study

Antonio Gatti, Marta Gentili, Vittorio Iorno, Massimo Mammucari, Giuseppe Tufaro, Marzia Lazzari, Alessandro Fabrizio Sabato

Research output: Contribution to journalArticlepeer-review


Introduction: Breakthrough pain (BTP) is traditionally defined as a transitory pain flare in opioid-treated patients with chronic background pain. This definition has, however, been challenged in recent years. This study aimed to analyze BTP prevalence in different pain conditions. Methods: This was a prospective, noninterventional, observational study conducted from June to September 2011 in two Italian pain treatment reference centres. Consecutive patients aged >18 years with oncological or non-oncological pain were eligible for this study; background pain was acute/ subacute (≤3 months) or chronic (>3 months). The characteristics of pain were evaluated by means of a structured interview by physicians, and patients were asked to complete a dedicated clinical study form. The following outcomes were assessed: chronic pain duration (in patients with chronic pain), BTP prevalence, and number and severity of daily BTP episodes. All outcomes were assessed in four populations of patients with: (a) chronic oncological pain; (b) chronic non-oncological pain; (c) non-chronic oncological pain; (d) nonchronic non-oncological pain. The correlation between BTP and gender was also investigated. Results: Of 1,270 patients with chronic pain, 1,086 had non-oncological pain (85.5%). Most patients (68.6%) with non-oncological pain were female (P = 0.001). Pain duration was significantly longer in non-oncological pain versus oncological pain groups (P = 0.002). BTP prevalence was lower in non-oncological patients (P ≤ 0.001). No differences were reported in terms of number and severity of daily BTP episodes. BTP was more frequent in females with non-oncological pain (P = 0.04). Females had a significantly higher pain severity (P = 0.02) than males. Conclusion: BTP is frequently reported in patients who do not have BTP according to the traditional definition. BTP frequency and severity is similar in oncological and non-oncological pain.

Original languageEnglish
Pages (from-to)298-305
Number of pages8
JournalAdvances in Therapy
Issue number3
Publication statusPublished - 2013


  • Breakthrough pain
  • Chronic pain
  • Gender
  • Non-oncological pain
  • Observational study
  • Oncological pain
  • Pain severity

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)


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