临床试验/NCT00564603

NCT00564603已完成4 期

Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy

Nanjing Medical University1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2007年8月最近更新: 2008年4月21日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 300
试验地点: 1
主要终点: Visual analog scale (VAS) of pain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 19 Years 至 64 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•ASA physical status I-II
•Uterus myoma

排除标准

•Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
•Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
•Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
•Those who were not willing to or could not finish the whole study at any time.
•Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

研究组 & 干预措施

1

Placebo Comparator

Saline with same volume added to tramadol infusion combined with morphine PCA.

干预措施: 0.9% Saline (Other)

2

Active Comparator

Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.

干预措施: Dexamethasone Sodium Phosphate Injection (Drug)

结局指标

主要结局

Visual analog scale (VAS) of pain

时间窗: 0-48h after surgeries

次要结局

First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;(0-48h after surgeries)

研究者

发起方

Nanjing Medical University

申办方类型

Other

研究点 (1)

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