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E-pub ahead of print

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

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Vis graf over relationer

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 is 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: 1-year follow-up was complete for 551patients (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 to 2.33, P = 0.20).

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.

EDITORIAL COMMENT: For this clinical trial of acute pain management after total hip replacement surgery, an additional planned assessment for long term follow-up for harm is presented here. No difference in serious adverse events between the 2 treatments, paracetamol vs ibuprofen, were observed at 1 year after surgery.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
ISSN0001-5172
DOI
StatusE-pub ahead of print - 9 apr. 2020

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