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.

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

Conflict of interest statement

Ethics approval and consent to participate

The PANSAID trial was approved by the Regional Ethics Commitee, Region Zealand, SJ-462, on 30 June 2015 (which covers all trial sites), approved by the Danish Medicines Agency, journal no. 2015053406, EudraCT: 2015-002239-16 on 12 August 2015, and approved by the Danish Data Protection Agency, REG-33-2015, on 30 June 2015.

All participants considered for the trial will be provided with written and oral information on the trial so that the participants can make an informed decision about their participation in the trial. Written information and the consent form are approved by the Ethics Committee. This consent form must be signed by the participant and by the investigator seeking the consent. Patients will only be enrolled after written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

CONSORT Flow-diagram

Fig. 2

SPIRIT figure: PANSAID