Effect of Combinations of Paracetamol, Ibuprofen, and Dexamethasone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty. The RECIPE Randomized Clinical Trial - RECIPE

Daniel Hägi-Pedersen0 个研究点目标入组 1,060 人2019年9月26日

概览

暂无简介。

注册库

who.int

开始日期

2019年9月26日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Daniel Hägi-Pedersen

•Scheduled for elective, unilateral, primary total hip arthroplasty
•BMI \> 18 and \< 40
•Negative urine HCG pregnancy test and use of anti\-conception for women in the fertile age
•Give written informed consent to participate 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 424
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 636

•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 daily use of systemic glucocorticoids (within 3 months before the trial)
•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 x 109/l); or against treatment with glucocorticoids
•Dysregulated diabetes (investigator’s judgement)