Ramila Shilpakar, K C Anuj, Bibek Acharya, Sandhya Chapagain, Shama Pandey, Prakash Neupane, Bishal Poudel, Soniya Dulal, Bishnu Dutta D Poudel
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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.</p><p><strong>Results: </strong>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 (<i>p</i> < 0.001). The number of patients with highly meaningful pain reduction was significantly higher in MOR than in TRM (76.5% versus 32.35%; <i>p</i> < 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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11460,"journal":{"name":"ecancermedicalscience","volume":"19 ","pages":"1864"},"PeriodicalIF":1.2000,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12146575/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparison of the effectiveness of oral morphine versus oral tramadol on early pain control in opioid-naive patients with moderate cancer pain.\",\"authors\":\"Ramila Shilpakar, K C Anuj, Bibek Acharya, Sandhya Chapagain, Shama Pandey, Prakash Neupane, Bishal Poudel, Soniya Dulal, Bishnu Dutta D Poudel\",\"doi\":\"10.3332/ecancer.2025.1864\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> < 0.001). The number of patients with highly meaningful pain reduction was significantly higher in MOR than in TRM (76.5% versus 32.35%; <i>p</i> < 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.</p><p><strong>Conclusion: </strong>In this study, MOR was superior to TRM in the control of pain with statistically significant differences in the primary and secondary endpoints. 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引用次数: 0
摘要
目的：采用埃德蒙顿症状评估量表（ESAS）比较口服吗啡（MOR）与口服曲马多（TRM）对中度癌性疼痛（MCP）患者的疼痛控制和身体健康状况的影响。方法：一项机构审查委员会（IRB）批准的随机II期试验在阿片类药物初治的MCP患者中进行，MCP的定义是疼痛评分（NRS）为4-6。患者随机接受MOR糖浆5毫克，每小时4次或TRM 50毫克，每天4次。如果根据MOR的标准推荐疼痛控制不足，两组均进行剂量滴定3天，或直到TRM的最大推荐日剂量。第4天将MOR改为延长释放形式。主要终点是早期应答者的数量，定义为第3天NRS疼痛强度至少降低20%的患者。次要终点是高度有意义的疼痛减轻的患者数量，定义为NRS疼痛强度降低≥5，第7天ESAS时身体健康状况改善。结果：68名患者同意并随机分组，每组34名。主要终点发生在MOR的94.1%和TRM的55.9% （p < 0.001）。高度有意义的疼痛减轻的患者数量在MOR组明显高于TRM组(76.5% vs 32.35%；P < 0.001)。根据ESAS评估，MOR组总体身体健康状况的改善更好。在治疗组之间没有发现不良反应的差异。结论：在本研究中，MOR对疼痛的控制优于TRM，主要和次要终点的差异有统计学意义。因此，早期使用MOR跳过世界卫生组织的顺序镇痛阶梯治疗MCP可能是资源稀缺、医疗保健机会有限的国家的更高价值选择。
Comparison of the effectiveness of oral morphine versus oral tramadol on early pain control in opioid-naive patients with moderate cancer pain.
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.
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