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Trials. 2017 Oct 10;18(1):465. 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.

Author information

1
Department of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark. khty@regionsjaelland.dk.
2
Copenhagen Trial Unit, Rigshospitalet, Dept. 7812, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
3
Department of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
4
Department of Anaesthesiology, Gildhøj Privathospital, Brøndbyvester Blvd. 16, 2605, Brøndby, Denmark.
5
Department of Anaesthesiology, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark.
6
Department of Ortopedic Surgergy, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
7
Department of Anaesthesiology, Holbæk Hospital, Smedelundsgade 60, 4300, Holbæk, Denmark.
8
Department of Ortopedic Surgergy, Nykøbing Falster Hospital, Fjordvej 15, 4800, Nykøbing Falster, Denmark.
9
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark.
10
Department of Clinical Research, University of Southern Denmark, Sdr. Boulevard 29, DK-5000, Odense C, Denmark.
11
Centre of Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital Køge, Lykkebækvej 1, 4600, Køge, Denmark.

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.

KEYWORDS:

Benefit; Detailed statistical analysis plan; Harm; Ibuprofen; Multimodal analgesia; Paracetamol; Postoperative pain; Randomised controlled trial; Total hip arthroplasty

PMID:
29017585
PMCID:
PMC5634901
DOI:
10.1186/s13063-017-2203-1
[Indexed for MEDLINE]
Free PMC Article

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