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

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

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.

In: Trials, Vol. 18, 465, 2017.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Thybo, KH, Jakobsen, JC, Hägi-Pedersen, D, Pedersen, NA, Dahl, JB, Schrøder, HM, Bülow, HH, Bjørck, JG, Overgaard, S, Mathiesen, O & Wetterslev, J 2017, 'PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial', Trials, vol. 18, 465. https://doi.org/10.1186/s13063-017-2203-1

APA

Thybo, K. H., Jakobsen, J. C., Hägi-Pedersen, D., Pedersen, N. A., Dahl, J. B., Schrøder, H. M., Bülow, H. H., Bjørck, J. G., Overgaard, S., Mathiesen, O., & Wetterslev, J. (2017). PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial. Trials, 18, [465]. https://doi.org/10.1186/s13063-017-2203-1

Vancouver

Thybo KH, Jakobsen JC, Hägi-Pedersen D, Pedersen NA, Dahl JB, Schrøder HM et al. PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial. Trials. 2017;18. 465. https://doi.org/10.1186/s13063-017-2203-1

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. / PANSAID-PAracetamol and NSAID in combination : detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial. In: Trials. 2017 ; Vol. 18.

Bibtex

@article{d1082220b7bb4d2a8e163ae08cd258bf,
title = "PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial",
abstract = "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.",
author = "Thybo, {Kasper H{\o}jgaard} and Jakobsen, {Janus Christian} and Daniel H{\"a}gi-Pedersen and Pedersen, {Niels Anker} and Dahl, {J{\o}rgen Berg} and Schr{\o}der, {Henrik Morville} and B{\"u}low, {Hans Henrik} and Bj{\o}rck, {Jan Gottfrid} and S{\o}ren Overgaard and Ole Mathiesen and J{\o}rn Wetterslev",
year = "2017",
doi = "10.1186/s13063-017-2203-1",
language = "English",
volume = "18",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",

}

RIS

TY - JOUR

T1 - PANSAID-PAracetamol and NSAID in combination

T2 - detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial

AU - Thybo, Kasper Højgaard

AU - Jakobsen, Janus Christian

AU - Hägi-Pedersen, Daniel

AU - Pedersen, Niels Anker

AU - Dahl, Jørgen Berg

AU - Schrøder, Henrik Morville

AU - Bülow, Hans Henrik

AU - Bjørck, Jan Gottfrid

AU - Overgaard, Søren

AU - Mathiesen, Ole

AU - Wetterslev, Jørn

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

U2 - 10.1186/s13063-017-2203-1

DO - 10.1186/s13063-017-2203-1

M3 - Journal article

C2 - 29017585

VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 465

ER -

ID: 195223733