The PANSAID randomized clinical trial: A pre‐planned 1‐year follow‐up regarding harm. Issue 7 (23rd April 2020)

• Record Type: Journal Article
• Authors: Thybo, Kasper H.; Hägi‐Pedersen, Daniel; Wetterslev, Jørn; Overgaard, Søren; Mathiesen, Ole
• Is Part Of: Acta anaesthesiologica scandinavica. Volume 64:Issue 7(2020:Aug.)
• Page Start: 910
• Page End: 912
• Publication Date: 2020-04-23
• Subjects: Anesthesiology -- Periodicals; Critical care medicine -- Periodicals; 617.9605
• DOI: 10.1111/aas.13597
• Languages: English
• ISSNs: 0001-5172

Abstract

Abstract : Background: Limiting harm from postoperative pain treatment is important. However, long‐term follow‐up from acute pain trials are rare. The aim of the study was to provide long‐term follow‐up data regarding harm from the "Paracetamol and Ibuprofen in Combination" (PANSAID) trial. Methods: In this preplanned long‐term follow‐up study from the PANSAID trial, we used data from Danish national health registries (the Danish National Patient Registry and the Danish Civil Registration System) in addition to the 90‐day follow‐up in the original trial. The primary outcome was 1‐year proportion of patients with one or more serious adverse events. Results: One‐year follow‐up was complete for 551 patients (99%). We found three additional patients with one or more serious adverse events in the 1‐year follow‐up compared with the 90‐day follow‐up. The relative risk of having one or more serious adverse event when randomized to ibuprofen compared with paracetamol was 1.40 (95% CI: 0.84‐2.33, P = .20). Conclusion: We found no statistically significant difference in 1‐year serious adverse events between patients randomized to ibuprofen compared with paracetamol in patients having planned primary total hip arthroplasty. There were few additional events from the 90‐day follow‐up to the 1‐year follow‐up.