临床试验/NCT01414569

NCT01414569已完成4 期

High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial

University of Aarhus1 个研究点分布在 1 个国家目标入组 97 人开始时间: 2011年11月最近更新: 2013年6月4日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: University of Aarhus
入组人数: 97
试验地点: 1
主要终点: Pain score by numeric rating scale

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

The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.

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: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Arthroscopic subacromial decompression and/or acromioclavicular resection
•General anaesthesia
•Daysurgery, Horsens Hospital

排除标准

•Incompetent
•Age under 18 or over 90 years
•Allergy toward dexamethasone
•Active gastric ulcer
•Untreated hypertension
•Daily use of glucocorticoids or strong opioids
•Daily use of analgesics for unrelated illness
•Myasthenia gravis
•Mitochondrial disorders

研究组 & 干预措施

8 mg dexamethasone

Active Comparator

干预措施: Dexamethasone (Drug)

Placebo, saline

Placebo Comparator

干预措施: Dexamethasone (Drug)

40 mg dexamethasone

Experimental

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Pain score by numeric rating scale

时间窗: At 8 hours postoperatively

次要结局

Use of analgesics(During hospital stay, about 4 hours)
Pain score by numeric rating scale(At about 8 a.m. on the first postoperative day)

研究者

发起方

University of Aarhus

申办方类型

Other

责任方

Sponsor

研究点 (1)

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