TCTR20200201001已完成4 期
Comparative efficacy between paracetamol and paracetamol/tramadol in postoperative intertrochanteric fracture: A Noninferiority randomized control trial double-blind study
department of orthopedic hadyai hospital0 个研究点目标入组 60 人开始时间: 2020年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
The overall mean VAS from postsurgery to discharge day were slightly higher in paracetamol alone group compared to paracetamol/tramadol group. However, according to the 2.0 point of noninferiority margin of pain, the outcome parameters were not clinically different between two groups. In the case of a patient's acceptance of the side effects of opioids, prescribing tramadol may be acceptable to decrease the mean pain scores even the pain amelioration was slightly lower compared to paracetamol alone.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 60 Years 至 N/A (No limit)(—)
- 性别
- All
入选标准
- •The intertrochanteric fracture patients who were diagnosed by hip X-ray plain film assessing with anteroposterior (AP) view and lateral cross table, classified by AO/OTA classification (Figure 1), were eligible to enroll on the study. All patients were aged > 60 years, diagnosed with intertrochanteric fracture as aforementioned at either emergency room (ER) or out-patient department (OPD) service. Furthermore, all patients were required to understand the Thai language in terms of written and spoken abilities.
排除标准
- •patients with multiple traumas, liver cirrhosis, disorientation, and a history of drug allergy to paracetamol, morphine, and tramadol were excluded from the study. According to the surgical procedures, the patients who were undergoing procedures other than cephalomedullary nail were also considered excluded from the study.
研究者
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