NCT01304134已完成3 期
A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Measuring VAS
研究概览
简要总结
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.
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 (Participant)
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
- •Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
- •ASA I and II.
- •Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
- •Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
- •Patients who are willing to participate in the study and have signed the written informed consent.
- •Negative pregnancy test result should be obtained for women of child-bearing age.
排除标准
- •Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
- •Body weight is less than or over ±15% of the standard body weight.
- •Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
- •Medical history of recovering from abnormal surgery anesthesia.
- •Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
- •Esophagus reflux disease.
- •Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
- •Have known hypersensitivity to opioids.
- •Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
- •Patients with shock.
- •Patients with COPD.
- •Patients can not understand the VAS or unable to use PCA.
- •Pregnant or parturient women.
研究组 & 干预措施
Oxycodone i.v.
Experimental
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
干预措施: Oxycodone (Drug)
Morphine i.v.
Active Comparator
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
干预措施: Morphine (Drug)
结局指标
主要结局
Measuring VAS
时间窗: 48 hours post operation
Measuring resting and coughing VAS, assessing the intensity of pain
次要结局
- Dosage(Within 48h)
- The invalid times and the total times of PCA application(48hrs)
- Satisfaction degree for analgesia(48hrs)
- The dosage of other rescue analgesic drugs used within 48h post-operation.(48hrs)
- AE occurrence and abnormal lab value(48hrs)
研究者
研究点 (1)
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