Evidence map›Paper›PMID 28069072›Full record

Trial reportTrials2017

PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial.

Kasper Højgaard Thybo, Daniel Hägi-Pedersen, Jørn Wetterslev, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Ole Mathiesen

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
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 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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)
NCT04414995 phase2 / phase3completednot on this mapstarted 2020, after this paper: background citation

Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty

TypeinterventionalSponsorIndonesia UniversityRan2020 to 2020Enrolled36ConditionsAnalgesiaArmsParacetamol injection and Ibuprofen injection, Paracetamol injection and normal saline, Ibuprofen Injection and normal saline
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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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

8 authors.

Kasper Højgaard ThyboDepartment of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark. khty@regionsjaelland.dk.
Daniel Hägi-PedersenDepartment of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
Jørn WetterslevCopenhagen Trial Unit, Rigshospitalet, Department 7812, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
Jørgen Berg DahlDepartment of Anaesthesiology, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, NV, Denmark.
Henrik Morville SchrøderDepartment of Orthopedic Surgery, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
Hans Henrik BülowDepartment of Anaesthesiology, Holbæk Hospital, Smedelundsgade 60, 4300, Holbæk, Denmark.
Jan Gottfrid BjørckDepartment of Orthopedic Surgery, Nykøbing Falster Hospital, Fjordvej 15, 4800, Nykøbing Falster, Denmark.
Ole MathiesenDepartment of Anaesthesiology, Zealand University Hospital Køge, Lykkebækvej 1, 4600, Køge, 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. No 'gold standard' exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA.

methodsPANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients and statisticians. Patients are randomised to four groups: (A) paracetamol 1 g × 4 and ibuprofen 400 mg × 4, (B) paracetamol 1 g × 4 and placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5 g × 4 and ibuprofen 200 mg. The two co-primary outcomes are 24-h consumption of morphine and number 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 number of patients with one or more adverse events within 24 h postoperatively. Inclusion criteria are patients scheduled for unilateral, primary THA; age above 18 years; ASA status 1-3; BMI >18 and <40 kg/m DISCUSSION: We started recruiting patients in December 2015 and expect to finish in September 2017. Data analysis will be from September 2017 to October 2017 and manuscript submission ultimo 2017.

trial registrationEudraCT: 2015-002239-16 (12/8-15); ClinicalTrials.gov: NCT02571361 . Registered on 7 October 2015.

Indexed as

Clinical ProtocolsAcetaminophenAnti-Inflammatory Agents, Non-SteroidalDrug Therapy, CombinationHumansIbuprofenOutcome Assessment, Health CarePostoperative PainAcetaminophenAnti-Inflammatory Agents, Non-SteroidalIbuprofenBenefitHarmIbuprofenMultimodal analgesiaParacetamolPostoperative painTotal hip arthroplasty

Identifiers

PMID28069072
PMCPMC5223299

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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.