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The PANSAID Randomized Clinical Trial: A pre-planned 1-year follow-up regarding harm

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Thybo, Kasper H ; Hägi-Pedersen, Daniel ; Wetterslev, Jørn ; Overgaard, Søren ; Mathiesen, Ole. / The PANSAID Randomized Clinical Trial : A pre-planned 1-year follow-up regarding harm. In: Acta Anaesthesiologica Scandinavica. 2020 ; Vol. 64, No. 7. pp. 910-912.

Bibtex

@article{6d98b0ad5cc44ae093b88ed175db01d8,
title = "The PANSAID Randomized Clinical Trial: A pre-planned 1-year follow-up regarding harm",
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.",
author = "Thybo, {Kasper H} and Daniel H{\"a}gi-Pedersen and J{\o}rn Wetterslev and S{\o}ren Overgaard and Ole Mathiesen",
note = "{\circledC} 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",
year = "2020",
month = "8",
doi = "10.1111/aas.13597",
language = "English",
volume = "64",
pages = "910--912",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
publisher = "Wiley-Blackwell Munksgaard",
number = "7",

}

RIS

TY - JOUR

T1 - The PANSAID Randomized Clinical Trial

T2 - A pre-planned 1-year follow-up regarding harm

AU - Thybo, Kasper H

AU - Hägi-Pedersen, Daniel

AU - Wetterslev, Jørn

AU - Overgaard, Søren

AU - Mathiesen, Ole

N1 - © 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

PY - 2020/8

Y1 - 2020/8

N2 - 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.

AB - 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.

U2 - 10.1111/aas.13597

DO - 10.1111/aas.13597

M3 - Journal article

VL - 64

SP - 910

EP - 912

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 7

ER -

ID: 59655991