Dexamethasone twice for pain treatment of total knee arthroplasty(DEX-2-TKA)A randomized blinded placebo-controlled clinical trial

aestved Hospital0 个研究点目标入组 486 人开始时间: 2018年5月25日最近更新: 2021年6月7日

试验速览

暂无简介。

•Scheduled for unilateral, primary TKA, not Oxford (uni-knee”).
•BMI = 18.0 and = 40.0
•Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
•Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions
•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 186
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•Patients who cannot cooperate with the trial
•Concomitant participation in another trial involving medication
•Patients who cannot understand or speak Danish
•Patients with allergy to medication used in the trial
•Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
•Patients with at daily use of systemic glucocorticoids
•Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.
•Dysregulated diabetes (investigators judgement)
•Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement

发起方

aestved Hospital