文章基本信息

标题：PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
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作者：Kasper Højgaard Thybo ; Janus Christian Jakobsen ; Daniel Hägi-Pedersen 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2017
卷号：18
期号：1
页码：465
DOI：10.1186/s13063-017-2203-1
语种：English
出版社：BioMed Central
摘要：Background Effective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen. This paper describes in detail the statistical analysis plan for the primary publication to prevent outcome reporting bias and data-driven analysis results. Methods/design The PANSAID trial is a multicentre, randomised, controlled, parallel, four-group clinical trial comparing the beneficial and harmful effects of different doses and combinations of paracetamol and ibuprofen in patients having total hip arthroplastic surgery. Patients, caregivers, physicians, investigators, and statisticians are blinded to the intervention. The two co-primary outcomes are 24-h consumption of morphine and proportion of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and the proportion of patients with one or more adverse events within 24 h postoperatively. Discussion PANSAID will provide a large trial with low risk of bias regarding benefits and harms of the combination of paracetamol and ibuprofen used in a perioperative setting. Trial registration ClinicalTrials.org identifier: NCT02571361 . Registered on 7 October 2015.
关键词：Ibuprofen ; Paracetamol ; Total hip arthroplasty ; Benefit ; Harm ; Multimodal analgesia ; Postoperative pain ; Detailed statistical analysis plan ; Randomised controlled trial