[Slow release tramadol in the initial treatment of moderate to severe cancer pain: open, multicentric clinical trial].

Introduction: The analgesic efficacy of slow release tramadol in the titration phase of treatment of moderate to severe cancer pain has been demonstrated in clinical trials.

Objective: The aim of the study was to evaluate this treatment strategy in routine daily practice.

Method: This was a prospective, non-randomized, open, multicentric, phase IV two-week study. Each patient received 100 mg slow release tramadol orally, twice a day. Patients were allowed to take 20 drops (50 mg) of tramadol as needed for breakthrough pain. The pain intensity and tramadol tolerability were recorded every day for the previous 24 hours, in the first week and at the end of the study. Pain relief and the impact of pain on sleep were evaluated on the 8th and 15th day.

Results: The study included 46 patients with metastatic malignant disease. The total of 46 patients completed the first week of treatment, and 33 patients completed the whole study. At the end of study, the intensity of pain was significantly reduced from 6.75 to 3.03 on numerical scale (NS 0-100) (p < 0.001). At the end of study, 60.6% of patients graded the severity of pain as maximally mild on a verbal scale. The pain relief significantly improved from 25.75 to 71.81 on a numerical scale (NS 0-100) (p < 0.001). The impact of pain on sleep was significantly reduced from 51.51% to 10.61% on a numerical scale (NS 0-100) (p < 0.001). There were no differences in the drowsiness/confusion, nausea, vomiting, dizziness, loss of appetite and constipation, from the beginning to the end of treatment.

Conclusion: Tramadol slow release was effective in the titration phase of treatment of moderate to severe cancer pain with good tolerability.