Evidence map›Paper›PMID 26787797›Full record

Trial reportBritish journal of anaesthesia2016

Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.

H J McQuay, R A Moore, A Berta, O Gainutdinovs, B Fülesdi, N Porvaneckas, S Petronis, M Mitkovic, L Bucsi, L Samson and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of anaesthesia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01902134 (A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain After Elective Unilateral Total Hip Arthroplasty), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% of its field
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.

NCT01902134 phase3completednot on this map

A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain After Elective Unilateral Total Hip Arthroplasty

TypeinterventionalSponsorMenarini GroupRan2013 to 2014Enrolled641ConditionsAcute PainArmsPlacebo, Tramadol-single dose, Dexketoprofen-single dose, Dexketoprofen/Tramadol-single dose, Tramadol-multiple doses
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

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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

17 authors at 11 institutions in 8 countries.

H J McQuayBalliol College, University of Oxford, Oxford, UK henrymcquay@gmail.com.
R A MoorePain Research & Nuffield Division of Anaesthetics, University of Oxford, The Churchill, Oxford OX1 3BJ, UK.
A BertaDepartment of Orthopaedics, Uzsoki Hospital, Budapest, Hungary.
O GainutdinovsDepartment of Joint Surgery, Hospital of Traumatology and Orthopaedics, Riga, Latvia.
B FülesdiDepartment of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary.
N PorvaneckasDepartment of Traumatology and Orthopaedics, Republican Vilnius University Hospital, Vilnius, Lithuania.
S PetronisDepartment of Traumatology and Orthopaedics, Riga's 2nd Hospital, Riga, Latvia.
M MitkovicClinic for Orthopaedics and Traumatology, Clinical Center Nis, University of Nis, Nis, Serbia.
L BucsiDepartment of Orthopaedics, St George University Teaching Hospital, Szekesfehervar, Hungary.
L SamsonDepartment of Orthopaedics, MÁV Hospital, Szolnok, Hungary.
V ZegunisDepartment of Traumatology, Klaipeda University Hospital, Klaipeda, Lithuania.
M L AnkinOrthopedic & Trauma Center, Kiev Regional Clinical Hospital, Kiev, Ukraine.
M BertolottiClinical Research, Menarini Ricerche S.p.A. - Menarini Group, Florence, Italy.
B Pizà-VallespirClinical Research, Laboratorios Menarini S.A. - Menarini Group, Badalona, Spain.
S CuadripaniClinical Research, Laboratorios Menarini S.A. - Menarini Group, Badalona, Spain.
M P ContiniClinical Research, Menarini Ricerche S.p.A. - Menarini Group, Florence, Italy.
A NizzardoClinical Research, Menarini Ricerche S.p.A. - Menarini Group, Florence, Italy.
Menarini Group (Italy) · ITBadalona Serveis Assistencials · ESUniversity of Oxford · GBKlaipėda University · LTKodolányi János University of Applied Sciences · HUKyiv City Clinical Oncology Center · UARiga East University Hospital · LVUniversity of Debrecen · HUUniversity of Nis · RSUzsoki Hospital · HUVilnius University · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty.

methodsThis was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8).

resultsOverall, 641 patients, mean age 62 (range 29-80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4-73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5-76). The single components were superior to placebo (P<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups.

conclusionThe efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy. CLINICAL

trial registrationEudraCT 2012-004548-31 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004548-31);ClinicalTrials.gov NCT01902134 (https://www.clinicaltrials.gov/ct2/show/NCT01902134?term=NCT01902134&rank=1).

Indexed as

Arthroplasty, Replacement, HipAdultAgedAged, 80 and overAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodDrug Therapy, CombinationFemaleHumansKetoprofenMaleMiddle AgedPostoperative PainSeverity of Illness IndexTramadolAnalgesics, OpioidAnti-Inflammatory Agents, Non-Steroidaldexketoprofen trometamolKetoprofenTramadolTromethamineanalgesicsarthroplasty, replacement, hipdexketoprofen trometamolpain, postoperativetramadol

Identifiers

PMID26787797
PMCPMC4718147
OpenAlexW2316701106

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.