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

Kasper Højgaard Thybo; Janus Christian Jakobsen; Daniel Hägi-Pedersen; Niels Anker Pedersen; Jørgen Berg Dahl; Henrik Morville Schrøder; Hans Henrik Bülow; Jan Gottfrid Bjørck; Søren Overgaard; Ole Mathiesen; Jørn Wetterslev

doi:10.1186/s13063-017-2203-1

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

Kasper Højgaard Thybo, Janus Christian Jakobsen, Daniel Hägi-Pedersen, Niels Anker Pedersen, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Søren Overgaard, Ole Mathiesen, Jørn Wetterslev

Department of Clinical Medicine

5 Citations (Scopus)

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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.

Original language	English
Article number	465
Journal	Trials
Volume	18
Number of pages	7
ISSN	1745-6215
DOIs	https://doi.org/10.1186/s13063-017-2203-1
Publication status	Published - 10 Oct 2017

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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, Article 465. https://doi.org/10.1186/s13063-017-2203-1

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

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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",

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day = "10",

doi = "10.1186/s13063-017-2203-1",

language = "English",

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journal = "Trials",

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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 - 2017/10/10

Y1 - 2017/10/10

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

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

M1 - 465

ER -

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

Abstract

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