Open-label Study of the Safety and Effectiveness of Short-term Therapy With Extended-release Tramadol (TRAMADEX-OD) in the Management of Pain After Knee Arthroscopy.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety and effectiveness of TRAMADEX-OD will be evaluated by recording adverse events and using a visual analogue score for pain evaluation
研究概览
简要总结
Extended-release tramadol is indicated for the management of moderate to severe pain in adults who require around-the-clock treatment. It provides an extended duration of action, more constant plasma concentrations, a reduced dosing frequency, and the potential for improved compliance and therapeutic outcomes.
The present study was designed to evaluate the safety and effectiveness of this medication in the treatment of early postoperative pain after knee arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and nonpregnant women
- •Age: 18-65 years
- •ASA classification I or II
- •ambulatory knee arthroscopy under spinal anesthesia
排除标准
- •Pregnancy
- •Intolerance to any opioid, tramadol or paracetamol
- •spine surgery in the past
- •renal or hepatic impairment
- •cardiac or respiratory conditions that put the patient at risk for respiratory depression
- •patients receiving: monoamine oxidase inhibitors, carbamazepine, quinidine, selective serotonin reuptake inhibitors or tricyclic antidepressants
研究组 & 干预措施
Tramadex-OD
Patients will undergo knee arthroscopy under spinal anesthesia without any opioid. 30 minutes prior to surgery and 24 hours afterwards, patients will take a tablet of 100 mg Tramadex-OD. Breakthrough pain will be managed with 1 gr paracetamol (per os) as needed.
干预措施: extended-release tramadol (Drug)
Control group
Patients will undergo knee arthroscopy under spinal anesthesia without any opioid.Postoperative pain will be managed throughout the study with 1 gr paracetamol (per os) every 6 hours as required.
干预措施: paracetamol (Drug)
结局指标
主要结局
Safety and effectiveness of TRAMADEX-OD will be evaluated by recording adverse events and using a visual analogue score for pain evaluation
时间窗: up to 48 hours
次要结局
- Patient satisfaction will be evaluated by a telephone interview(up to 48 hours)