Evidence map›Paper›PMID 29017585›Full record

Trial reportTrials2017

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 and 1 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02571361 (PAracetamol and NSAID in Combination), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02571361 phase4completednot on this map

PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial

TypeinterventionalSponsorDaniel Hägi-PedersenRan2015 to 2018Enrolled556ConditionsPain, PostoperativeArmsParacetamol (1g x 4), Ibuprofen (400 mg x 4), Paracetamol (0,5 g x 4), Ibuprofen (200 mg x 4), Placebo (x4)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kasper Højgaard ThyboDepartment of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark. khty@regionsjaelland.dk.
Janus Christian JakobsenCopenhagen Trial Unit, Rigshospitalet, Dept. 7812, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
Daniel Hägi-PedersenDepartment of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
Niels Anker PedersenDepartment of Anaesthesiology, Gildhøj Privathospital, Brøndbyvester Blvd. 16, 2605, Brøndby, Denmark.
Jørgen Berg DahlDepartment of Anaesthesiology, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark.
Henrik Morville SchrøderDepartment of Ortopedic Surgergy, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
Hans Henrik BülowDepartment of Anaesthesiology, Holbæk Hospital, Smedelundsgade 60, 4300, Holbæk, Denmark.
Jan Gottfrid BjørckDepartment of Ortopedic Surgergy, Nykøbing Falster Hospital, Fjordvej 15, 4800, Nykøbing Falster, Denmark.
Søren OvergaardDepartment of Orthopaedic Surgery and Traumatology, Odense University Hospital, Sdr. Boulevard 29, DK-5000, Odense C, Denmark.
Ole MathiesenCentre of Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital Køge, Lykkebækvej 1, 4600, Køge, Denmark.
Jørn WetterslevCopenhagen Trial Unit, Rigshospitalet, Dept. 7812, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffective 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/

designThe 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 registrationClinicalTrials.org identifier: NCT02571361 . Registered on 7 October 2015.

Indexed as

AcetaminophenAnalgesics, Non-NarcoticAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalArthroplasty, Replacement, HipClinical ProtocolsData Interpretation, StatisticalDenmarkDrug CombinationsFemaleHumansIbuprofenMaleMorphinePain MeasurementPostoperative PainAcetaminophenAnalgesics, Non-NarcoticAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalDrug CombinationsIbuprofenMorphineBenefitDetailed statistical analysis planHarmIbuprofenMultimodal analgesiaParacetamolPostoperative painRandomised controlled trialTotal hip arthroplasty

Identifiers

PMID29017585
PMCPMC5634901

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.