Assessment of analgesia and adverse effects of controlled release tramadol and dihydrocodeine in patients with cancer pain – based on a modified ESAS

Material and methods: Open, prospective, randomised, cross-over study of 30 patients with nociceptive (visceral or somatic) cancer pain treated previously with non-opioids who received tramadol (15 patients) or dihydrocodeine (DHC) (15 patients) in controlled release tablets for 7 days, then drugs changed and administered for the next 7 days. Analgesia assessed by visual – analogue scale (VAS), adverse effects by modified ESAS (Edmonton Symptom Assessment System) with two additional scales for constipation and vomiting. Starting doses: tramadol 100 mg, DHC 60 mg both twice daily, titrated to satisfactory analgesia.
Results: In both groups decrease of pain intensity, better analgesia with DHC. After study completion 19 patients preffered DHC, 4 tramadol, 7 assessed both drugs equally effective. In DHC group patients reported in the first 7 days less dyspnoea, in the second week more constipation and trend towards more drowsiness, more activity in the first week and better sensation of well-being during both weeks, tramadol caused more nausea during both treatment weeks. No differences in apetite and vomiting observed, in the first week patients treated with DHC were less anxious and less depressed. Serious adverse effects (respiratory depression, allergy for drugs) not observed.
Conclusions: Tramadol and DHC in controlled release tablets are effective analgesics in nociceptive cancer pain. No serious adverse effects observed, more constipation in DHC group indicates for prophylactic use of laxatives whereas more nausea in tramadol group is an indication for prophylactic antiemetic administration. Equianalgesic single doses of tramadol to DHC according to 10:6 ratio rendered satisfactory analgesia.