EUCTR2007-006117-16-GB进行中（未招募）1 期
A prospective, randomised, phase IV, open label clinical trial to study the therapeutic use of buprenorphine 20 mg (BuTrans 20µg/h) matrix transdermal patch in the management of post tonsillectomy pain in adults - PATCH Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients undergoing tonsillectomy, which meet the following criteria:
- •aged 18 to 50 years old;
- •ASA grade I & II - healthy patient; mild systemic disease with no functional limitation (e.g. well controlled HTA)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •age less than 18 or over 50;
- •ASA grade III - severe systemic disease with definite functional limitation e.g. unstable angina)
- •conditions in which the respiratory centre and function are severely impaired or may become so;
- •asthmatic and allergic to NSAIDS;
- •hypotension
- •pregnancy and lactation;
- •recent head injury;
- •known hypersensitivity towards the active substance buprenorphine or to any of the excipients (for the excipients see section 6.1);
- •in opioid-dependent patients and for narcotic withdrawal treatment;
- •patients who are receiving MAO inhibitors or have taken them within the last two weeks;
- •patients suffering from myasthenia gravis;
- •patients suffering from delirium tremens or acute alcohol intoxication;
- •convulsive disorders
研究者
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