Purpose: The purpose of this study was to compare the efficacy of oral morphine (MOR) with oral tramadol (TRM) in control of pain as well as physical well-being in patients (pts) with moderate cancer pain (MCP) using the Edmonton Symptom Assessment Scale (ESAS).

Methods: An Institutional Review Board (IRB) approved randomised phase II trial was performed in opioid-naive pts with MCP as defined by pain score in numerical rating score (NRS) of 4–6. Patients were randomised to receive MOR syrup 5 mg 4 hourly or TRM 50 mg four times a day. Titration of dose was done in both groups for 3 days in case of inadequate pain control as per standard recommendation for MOR or until the maximum recommended daily dose for TRM. MOR was changed to prolonged release form on Day 4. The primary endpoint was the number of early responders, defined as pts with at least 20% reduction in pain intensity on NRS on Day 3. The secondary outcome was the number of patients with highly meaningful pain reduction, defined as a decrease in pain intensity on NRS by ≥5 and improvement in physical well-being with ESAS at Day 7.

Results: Sixty-eight pts consented and were randomised, 34 in each arm. The primary endpoint occurred in 94.1% pts in MOR and 55.9% in TRM (p < 0.001). The number of patients with highly meaningful pain reduction was significantly higher in MOR than in TRM (76.5% versus 32.35%; p < 0.001). Improvement in general physical well-being as assessed by ESAS was better in the MOR group. No difference in adverse effects was noted between the treatment arms.

Conclusion: In this study, MOR was superior to TRM in the control of pain with statistically significant differences in the primary and secondary endpoints. Therefore, early use of MOR skipping the World Health Organization sequential analgesic ladder for MCP may be a higher value option in resource-scarce country with limited access to healthcare.