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, V. Zegunis, M. L. Ankin, M. Bertolotti, B. Pizà-Vallespir, S. Cuadripani, M. P. Contini, A. Nizzardo

Research output: Article

11 Citations (Scopus)

Abstract

Background: The 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. Methods: This 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). Results: Overall, 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

Original languageEnglish
Pages (from-to)269-276
Number of pages8
JournalBritish Journal of Anaesthesia
Volume116
Issue number2
DOIs
Publication statusPublished - febr. 1 2016

Fingerprint

Tramadol
Arthroplasty
Hip
Randomized Controlled Trials
Pain
Placebos
Confidence Intervals
Dipyrone
Acute Pain
Pain Measurement
Ambulatory Surgical Procedures
Analgesics
Safety
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. / McQuay, H. J.; Moore, R. A.; Berta, A.; Gainutdinovs, O.; Fülesdi, B.; Porvaneckas, N.; Petronis, S.; Mitkovic, M.; Bucsi, L.; Samson, L.; Zegunis, V.; Ankin, M. L.; Bertolotti, M.; Pizà-Vallespir, B.; Cuadripani, S.; Contini, M. P.; Nizzardo, A.

In: British Journal of Anaesthesia, Vol. 116, No. 2, 01.02.2016, p. 269-276.

Research output: Article

McQuay, HJ, Moore, RA, Berta, A, Gainutdinovs, O, Fülesdi, B, Porvaneckas, N, Petronis, S, Mitkovic, M, Bucsi, L, Samson, L, Zegunis, V, Ankin, ML, Bertolotti, M, Pizà-Vallespir, B, Cuadripani, S, Contini, MP & Nizzardo, A 2016, 'Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty', British Journal of Anaesthesia, vol. 116, no. 2, pp. 269-276. https://doi.org/10.1093/bja/aev457
McQuay, H. J. ; Moore, R. A. ; Berta, A. ; Gainutdinovs, O. ; Fülesdi, B. ; Porvaneckas, N. ; Petronis, S. ; Mitkovic, M. ; Bucsi, L. ; Samson, L. ; Zegunis, V. ; Ankin, M. L. ; Bertolotti, M. ; Pizà-Vallespir, B. ; Cuadripani, S. ; Contini, M. P. ; Nizzardo, A. / Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. In: British Journal of Anaesthesia. 2016 ; Vol. 116, No. 2. pp. 269-276.
@article{0e93765a95864a5594901d50773fdb5d,
title = "Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty",
abstract = "Background: The 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. Methods: This 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). Results: Overall, 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",
keywords = "analgesics, arthroplasty, replacement, hip, dexketoprofen trometamol, pain, postoperative, tramadol",
author = "McQuay, {H. J.} and Moore, {R. A.} and A. Berta and O. Gainutdinovs and B. F{\"u}lesdi and N. Porvaneckas and S. Petronis and M. Mitkovic and L. Bucsi and L. Samson and V. Zegunis and Ankin, {M. L.} and M. Bertolotti and B. Piz{\`a}-Vallespir and S. Cuadripani and Contini, {M. P.} and A. Nizzardo",
year = "2016",
month = "2",
day = "1",
doi = "10.1093/bja/aev457",
language = "English",
volume = "116",
pages = "269--276",
journal = "British Journal of Anaesthesia",
issn = "0007-0912",
publisher = "Oxford University Press",
number = "2",

}

TY - JOUR

T1 - Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty

AU - McQuay, H. J.

AU - Moore, R. A.

AU - Berta, A.

AU - Gainutdinovs, O.

AU - Fülesdi, B.

AU - Porvaneckas, N.

AU - Petronis, S.

AU - Mitkovic, M.

AU - Bucsi, L.

AU - Samson, L.

AU - Zegunis, V.

AU - Ankin, M. L.

AU - Bertolotti, M.

AU - Pizà-Vallespir, B.

AU - Cuadripani, S.

AU - Contini, M. P.

AU - Nizzardo, A.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Background: The 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. Methods: This 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). Results: Overall, 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

AB - Background: The 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. Methods: This 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). Results: Overall, 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

KW - analgesics

KW - arthroplasty, replacement, hip

KW - dexketoprofen trometamol

KW - pain, postoperative

KW - tramadol

UR - http://www.scopus.com/inward/record.url?scp=84961891974&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84961891974&partnerID=8YFLogxK

U2 - 10.1093/bja/aev457

DO - 10.1093/bja/aev457

M3 - Article

VL - 116

SP - 269

EP - 276

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 2

ER -