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

Betsi Cadwaladr University Health Board0 个研究点目标入组 300 人开始时间: 2007年11月26日最近更新: 2019年11月25日

试验速览

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•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

•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

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