Cargando…

PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Thybo, Kasper Højgaard, Jakobsen, Janus Christian, Hägi-Pedersen, Daniel, Pedersen, Niels Anker, Dahl, Jørgen Berg, Schrøder, Henrik Morville, Bülow, Hans Henrik, Bjørck, Jan Gottfrid, Overgaard, Søren, Mathiesen, Ole, Wetterslev, Jørn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5634901/
https://www.ncbi.nlm.nih.gov/pubmed/29017585
http://dx.doi.org/10.1186/s13063-017-2203-1
_version_ 1783270184502427648
author Thybo, Kasper Højgaard
Jakobsen, Janus Christian
Hägi-Pedersen, Daniel
Pedersen, Niels Anker
Dahl, Jørgen Berg
Schrøder, Henrik Morville
Bülow, Hans Henrik
Bjørck, Jan Gottfrid
Overgaard, Søren
Mathiesen, Ole
Wetterslev, Jørn
author_facet Thybo, Kasper Højgaard
Jakobsen, Janus Christian
Hägi-Pedersen, Daniel
Pedersen, Niels Anker
Dahl, Jørgen Berg
Schrøder, Henrik Morville
Bülow, Hans Henrik
Bjørck, Jan Gottfrid
Overgaard, Søren
Mathiesen, Ole
Wetterslev, Jørn
author_sort Thybo, Kasper Højgaard
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2203-1) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5634901
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-56349012017-10-19 PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial Thybo, Kasper Højgaard Jakobsen, Janus Christian Hägi-Pedersen, Daniel Pedersen, Niels Anker Dahl, Jørgen Berg Schrøder, Henrik Morville Bülow, Hans Henrik Bjørck, Jan Gottfrid Overgaard, Søren Mathiesen, Ole Wetterslev, Jørn Trials Update 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2203-1) contains supplementary material, which is available to authorized users. BioMed Central 2017-10-10 /pmc/articles/PMC5634901/ /pubmed/29017585 http://dx.doi.org/10.1186/s13063-017-2203-1 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Update
Thybo, Kasper Højgaard
Jakobsen, Janus Christian
Hägi-Pedersen, Daniel
Pedersen, Niels Anker
Dahl, Jørgen Berg
Schrøder, Henrik Morville
Bülow, Hans Henrik
Bjørck, Jan Gottfrid
Overgaard, Søren
Mathiesen, Ole
Wetterslev, Jørn
PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
title PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
title_full PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
title_fullStr PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
title_full_unstemmed PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
title_short PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
title_sort pansaid—paracetamol and nsaid in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5634901/
https://www.ncbi.nlm.nih.gov/pubmed/29017585
http://dx.doi.org/10.1186/s13063-017-2203-1
work_keys_str_mv AT thybokasperhøjgaard pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT jakobsenjanuschristian pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT hagipedersendaniel pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT pedersennielsanker pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT dahljørgenberg pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT schrøderhenrikmorville pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT bulowhanshenrik pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT bjørckjangottfrid pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT overgaardsøren pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT mathiesenole pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial
AT wetterslevjørn pansaidparacetamolandnsaidincombinationdetailedstatisticalanalysisplanforarandomisedblindedparallelfourgroupmulticentreclinicaltrial