Aims of the study: To assess analgesic efficacy and side effects of tramadol administered to patients with cancer pain.
Patients and methods: Retrospective analysis of 601 patients treated with oral tramadol normal release (556 patients-92.5%) and controlled release (45 patients-7.5%) preparations. 459 (76%) patients had moderate pain, 142 (24%) had severe or very severe pain. The single starting dose was 12.5 - 50 mg (normal release) and 100 mg (controlled release) and the maximum daily doe was 600 mg.
Results: Daily dose of tramadol ranged 50- 600 (mean 320) mg. The mean time of the treatment was 35 days. Good analgesia was observed in 453 (75.4%), partial effect in 78 (13%) and unsatisfactory effect in 70 (11.6%) patients. The distribution of the analgesic effect was similar for immediate and conntrolled release formulations. Most of the patients with severe pain had unsatisfactory analgesia whereas majority of patients with moderate anlgesia had good effect. In 242 (40.2%) of patients it was necessary to substitute tramadol with strong opioids (morphine or transdermal fentanyl). The most common side effects were constipation 156 (26%), nausea 85 (14%) and drowsiness 34 (5.6%). 37 (6.1%) patients ceased treatment due to side effects mainly nausea and dizziness. No allergy or respiratory depression was noted.
Conclusions: Treatment with oral immediate and controlled release tramadol is safe and effective in patients with moderate pain. The drug is less effective in patients with severe and very severe cancer pain.