Objective: The aim of this study was to prospectively assess the efficacy and safety of sublingual fentanyl (SLF) in doses proportional to opioid doses used for background analgesia for the treatment of BTP of cancer patients.
Methods: A sample of patients admitted to an acute palliative care unit, presenting breakthrough pain (BTP) episodes and receiving stable doses of opioids for background pain was selected to assess the efficacy and safety of SLF used in doses proportional to the basal opioid regimen used for the management of BTP. For each patient, data from four consecutive episodes were collected. For each episode, nurses collected changes in pain intensity and adverse effects when pain got severe (T0), and 5, 10, and 15 minutes after SLF was given (T15).
Results: Seventy patients were recruited for the study. The mean age was 61.7 (±11.5). Forty-one patients were males. A total of 173 episodes of BTP were recorded (mean 2.5 episodes/patient). In 19 events, documentation regarding changes in pain intensity was incomplete. Of the 154 evaluable episodes, 143 were successfully treated (92%). Mean doses of SLF were 637 µg (SD 786), and 51 patients (72.8%) received SLF doses ≥800 µg. When compared to younger adult patients, older patients received significantly lower doses of SLF (p < 0.0005) [DOSAGE ERROR CORRECTED], similarly to their lower basal opioid regimen. Pain intensity significantly decreased at T5, 10 and T15 (p < 0.0005). The number of patients with a pain reduction of more than 33% at T5, T10, and T15 were 11, 79, and 137, respectively, and the number of patients with a reduction in pain intensity of more than 50% were 1, 21, 114 at the same intervals, respectively. No differences in changes in pain intensity for gender (p < 0.9) or age (p < 0.85) were observed. No significant changes in the number of patients reporting adverse effects of mild-moderate intensity were reported after SLF administration in comparison with baseline, and no adverse effects severe enough in intensity to require medical intervention were observed. Limitations of this study are represented by the uncontrolled design.
Conclusion: This study suggests that SLF given in doses proportional to the basal opioid regimen for the management of BTP is safe and effective in clinical practice.