Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
研究概览
简要总结
Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the patient, including significant cardiovascular and respiratory complications. Apart from the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the treatment of DAPO, have shown to be as or more effective than intravenous or epidural regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20) undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at rest and effort, requirement for rescue intravenous morphine and incidence of side effects to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and patient satisfaction.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.
排除标准
- •Use of psychotropic medication or illicit drug use
- •Pregnancy
- •Liver disease
- •Opioid use
- •History of postoperative nausea and vomiting
- •Allergy or intolerance to any of the study drugs
- •Physical or mental inability to use the pain scale, or any surgical complications.
研究组 & 干预措施
Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
干预措施: Extended-release oxycodone (Drug)
Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
干预措施: Extended- release Oxycodone (Drug)
Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
干预措施: ketoprofen (Drug)
Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
干预措施: dipirone (Drug)
Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
干预措施: dexametasone (Drug)
Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
干预措施: Morphine IV (rescue) (Drug)
Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
干预措施: Extended-release oxycodone (Drug)
Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
干预措施: Extended- release Oxycodone (Drug)
Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
干预措施: ketoprofen (Drug)
Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
干预措施: dipirone (Drug)
Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
干预措施: dexametasone (Drug)
Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
干预措施: Morphine IV (rescue) (Drug)
结局指标
主要结局
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
时间窗: 24 hours
次要结局
- Percents of patients with adverse events because of treatment(24 hours)
研究者
Beatriz Arismendi Gómez
Medico Anestesiologo
Hospital Central Dr. Luis Ortega