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Published in: Advances in Therapy 11/2019

Open Access 01-11-2019 | Tramadol | Original Research

Expert Consensus on Clinical Use of an Orally Administered Dexketoprofen Plus Tramadol Fixed-Dose Combination in Moderate-To-Severe Acute Pain: A Delphi Study

Authors: Giustino Varrassi, Stefano Coaccioli, Josè De-Andrés, Magdi Hanna, Giorgos Macheras, Antonio Montero, Serge Perrot, Vincenzo Piras, Carmelo Scarpignato

Published in: Advances in Therapy | Issue 11/2019

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Abstract

Introduction

In 2016, the orally administered fixed-dose combination of dexketoprofen 25 mg and tramadol 75 mg (DKP/TRAM FDC) was approved in Europe for short-term treatment of moderate-to-severe acute pain, an indication that encompasses a wide range of post-operative and non-surgical painful conditions. This has suggested the necessity to have a clearer indication on its clinical use, with the support of expert pain clinicians, working in different medical specialities, and reinforced by the data present in the literature.

Methods

With the aim of assisting clinicians in the use of DKP/TRAM FDC in daily practice, two rounds of a modified Delphi process were conducted. In the first round, a board of nine experts developed a series of consensus statements based on available evidence, and their clinical experience, with DKP/TRAM FDC. In the second round, 75 clinicians with extensive experience in pain management expressed individually their agreement with the statements, using a dedicated online platform. Consensus was defined as at least 70% agreement.

Results

Twenty-eight statements were developed. Of these, 19 reached the defined level of consensus.

Conclusion

The agreed consensus statements may assist clinicians in applying the results of clinical studies and clinical experience to routine care settings, providing guidance for use of this new analgesic combination in moderate-to-severe post-operative and non-surgical acute pain.

Funding

Menarini Group.
Appendix
Available only for authorised users
Literature
1.
go back to reference Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010;23(6):697–703.CrossRef Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010;23(6):697–703.CrossRef
2.
go back to reference Raffa RB, Tallarida RJ, Taylor R Jr, Pergolizzi JV Jr. Fixed-dose combinations for emerging treatment of pain. Expert Opin Pharmacother. 2012;13(9):1261–70.CrossRef Raffa RB, Tallarida RJ, Taylor R Jr, Pergolizzi JV Jr. Fixed-dose combinations for emerging treatment of pain. Expert Opin Pharmacother. 2012;13(9):1261–70.CrossRef
3.
go back to reference Raffa RB, Pergolizzi JV Jr, Tallarida RJ. The determination and application of fixed-dose analgesic combinations for treating multimodal pain. J Pain. 2010;11(8):701–9.CrossRef Raffa RB, Pergolizzi JV Jr, Tallarida RJ. The determination and application of fixed-dose analgesic combinations for treating multimodal pain. J Pain. 2010;11(8):701–9.CrossRef
4.
go back to reference O’Brien J, Pergolizzi J, van de Laar M, et al. Fixed-dose combinations at the front line of multimodal pain management: perspective of the nurse-prescriber. Nurs Res Rev. 2013;3:9–22.CrossRef O’Brien J, Pergolizzi J, van de Laar M, et al. Fixed-dose combinations at the front line of multimodal pain management: perspective of the nurse-prescriber. Nurs Res Rev. 2013;3:9–22.CrossRef
5.
go back to reference Moore RA, Gay-Escoda C, Figueiredo R, et al. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541.CrossRef Moore RA, Gay-Escoda C, Figueiredo R, et al. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541.CrossRef
6.
go back to reference Gay-Escoda C, Hanna M, Montero A, et al. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open. 2019;9(2):e023715.CrossRef Gay-Escoda C, Hanna M, Montero A, et al. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open. 2019;9(2):e023715.CrossRef
7.
go back to reference Moore RA, McQuay HJ, Tomaszewski J, et al. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016;16:9.CrossRef Moore RA, McQuay HJ, Tomaszewski J, et al. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016;16:9.CrossRef
8.
go back to reference McQuay HJ, Moore RA, Berta A, et al. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016;116:269–76.CrossRef McQuay HJ, Moore RA, Berta A, et al. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016;116:269–76.CrossRef
9.
go back to reference Varrassi G, Hanna M, Macheras G, et al. Multimodal analgesia in moderate-to-severe pain: a role for a new fixed combination of dexketoprofen and tramadol. Curr Med Res Opin. 2017;33(6):1165–73.CrossRef Varrassi G, Hanna M, Macheras G, et al. Multimodal analgesia in moderate-to-severe pain: a role for a new fixed combination of dexketoprofen and tramadol. Curr Med Res Opin. 2017;33(6):1165–73.CrossRef
10.
go back to reference Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311:376–80.CrossRef Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311:376–80.CrossRef
11.
go back to reference Durand MA, Chantler R. Consensus groups in principles of social research. Maidenhead: Open University Press/McGraw-Hill; 2014. p. 64–6. Durand MA, Chantler R. Consensus groups in principles of social research. Maidenhead: Open University Press/McGraw-Hill; 2014. p. 64–6.
12.
go back to reference Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Chichester: Wiley-Blackwell; 2011. p. 208.CrossRef Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Chichester: Wiley-Blackwell; 2011. p. 208.CrossRef
13.
go back to reference Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Chichester: Wiley; 2010. p. 55. Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Chichester: Wiley; 2010. p. 55.
14.
go back to reference Diamond IR, Grant RC, Feldman BM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–9.CrossRef Diamond IR, Grant RC, Feldman BM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–9.CrossRef
15.
go back to reference McGurk M, Robinson P, Rajayogeswaran V, et al. Clinical comparison of dexketoprofen trometamol, ketoprofen, and placebo in postoperative dental pain. J Clin Pharmacol. 1998;38(12 Suppl):46S–54S.CrossRef McGurk M, Robinson P, Rajayogeswaran V, et al. Clinical comparison of dexketoprofen trometamol, ketoprofen, and placebo in postoperative dental pain. J Clin Pharmacol. 1998;38(12 Suppl):46S–54S.CrossRef
16.
go back to reference Derry S, Cooper TE, Phillips T. Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults. Cochrane Database Syst Rev. 2016;9:CD012232.PubMed Derry S, Cooper TE, Phillips T. Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults. Cochrane Database Syst Rev. 2016;9:CD012232.PubMed
17.
go back to reference Young AC, Buvanendran A. Pain management for total hip arthroplasty. J Surg Orthopaed Adv. 2014;23:13–21.CrossRef Young AC, Buvanendran A. Pain management for total hip arthroplasty. J Surg Orthopaed Adv. 2014;23:13–21.CrossRef
18.
go back to reference Au AH, Choi SW, Cheung CW, Leung YY. The efficacy and clinical safety of various analgesic combinations for post-operative pain after third molar surgery: a systematic review and meta-analysis. PLoS One. 2015;10(6):e0127611.CrossRef Au AH, Choi SW, Cheung CW, Leung YY. The efficacy and clinical safety of various analgesic combinations for post-operative pain after third molar surgery: a systematic review and meta-analysis. PLoS One. 2015;10(6):e0127611.CrossRef
19.
go back to reference Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131–57.CrossRef Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131–57.CrossRef
20.
go back to reference Cooper SA, Desjardins PJ. The value of the dental impaction pain model in drug development. Methods Mol Biol. 2010;617:175–90.CrossRef Cooper SA, Desjardins PJ. The value of the dental impaction pain model in drug development. Methods Mol Biol. 2010;617:175–90.CrossRef
21.
go back to reference Singla NK, Desjardins PJ, Chang PD. A comparison of the clinical and experimental characteristics of four acute surgical pain models: dental extraction, bunionectomy, joint replacement, and soft tissue surgery. Pain. 2014;155(3):441–56.CrossRef Singla NK, Desjardins PJ, Chang PD. A comparison of the clinical and experimental characteristics of four acute surgical pain models: dental extraction, bunionectomy, joint replacement, and soft tissue surgery. Pain. 2014;155(3):441–56.CrossRef
22.
go back to reference Barden J, Edwards JE, McQuay HJ, Moore AR. Pain and analgesic response after third molar extraction and other postsurgical pain. Pain. 2004;107(1–2):86–90.CrossRef Barden J, Edwards JE, McQuay HJ, Moore AR. Pain and analgesic response after third molar extraction and other postsurgical pain. Pain. 2004;107(1–2):86–90.CrossRef
23.
go back to reference Mauleon D, Artigas R, Garcia ML, et al. Preclinical and clinical development of dexketoprofen. Drugs. 1996;52(Suppl 5):24–45 (discussion 45–46).CrossRef Mauleon D, Artigas R, Garcia ML, et al. Preclinical and clinical development of dexketoprofen. Drugs. 1996;52(Suppl 5):24–45 (discussion 45–46).CrossRef
24.
go back to reference Perrot S. Osteoarthritis pain. Best Pract Res Clin Rheumatol. 2015;29:90–7.CrossRef Perrot S. Osteoarthritis pain. Best Pract Res Clin Rheumatol. 2015;29:90–7.CrossRef
25.
go back to reference Fusco M, Skaper S, Coaccioli S, Paladini A, Varrassi G. Degenerative joint diseases and neuroinflammation. Pain Pract. 2017;17:522–32.CrossRef Fusco M, Skaper S, Coaccioli S, Paladini A, Varrassi G. Degenerative joint diseases and neuroinflammation. Pain Pract. 2017;17:522–32.CrossRef
26.
go back to reference Dueñas M, Ojeda B, Salazar A, Mico JA, Failde I. A review of chronic pain impact on patients, their social environment and the health care system. J Pain Res. 2016;28(9):457–67.CrossRef Dueñas M, Ojeda B, Salazar A, Mico JA, Failde I. A review of chronic pain impact on patients, their social environment and the health care system. J Pain Res. 2016;28(9):457–67.CrossRef
27.
go back to reference Langley P, Mueller-Schwefe G, Nicolau A, Liedgens H, Pergolizzi J, Varrassi G. The societal impact of pain in European Union: health-related quality of life and healthcare resource utilization. J Med Econ. 2010;13:571–81.CrossRef Langley P, Mueller-Schwefe G, Nicolau A, Liedgens H, Pergolizzi J, Varrassi G. The societal impact of pain in European Union: health-related quality of life and healthcare resource utilization. J Med Econ. 2010;13:571–81.CrossRef
28.
go back to reference Jin J, Peng L, Chen Q, et al. Prevalence and risk factors for chronic pain following cesarean section: a prospective study. BMC Anesthesiol. 2016;16:99.CrossRef Jin J, Peng L, Chen Q, et al. Prevalence and risk factors for chronic pain following cesarean section: a prospective study. BMC Anesthesiol. 2016;16:99.CrossRef
29.
go back to reference Weibel S, Neubert K, Jelting Y, et al. Incidence and severity of chronic pain after caesarean section: a systematic review with meta-analysis. Eur J Anaesthesiol. 2016;33:853–65.CrossRef Weibel S, Neubert K, Jelting Y, et al. Incidence and severity of chronic pain after caesarean section: a systematic review with meta-analysis. Eur J Anaesthesiol. 2016;33:853–65.CrossRef
30.
go back to reference Gerbershagen HJ, Dagtekin O, Rothe T, et al. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009;13:853–60.CrossRef Gerbershagen HJ, Dagtekin O, Rothe T, et al. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009;13:853–60.CrossRef
31.
go back to reference Beswick AD, Wylde V, Gooberman-Hill R, et al. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2:e000435.CrossRef Beswick AD, Wylde V, Gooberman-Hill R, et al. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2:e000435.CrossRef
32.
go back to reference Simanski CJ, Althaus A, Hoederath S, et al. Incidence of chronic postsurgical pain (CPSP) after general surgery. Pain Med. 2014;15:1222–9.CrossRef Simanski CJ, Althaus A, Hoederath S, et al. Incidence of chronic postsurgical pain (CPSP) after general surgery. Pain Med. 2014;15:1222–9.CrossRef
33.
go back to reference Liu SS, Buvanendran A, Rathmell JP, et al. A cross-sectional survey on prevalence and risk factors for persistent postsurgical pain 1 year after total hip and knee replacement. Reg Anesth Pain Med. 2012;37:415–22.CrossRef Liu SS, Buvanendran A, Rathmell JP, et al. A cross-sectional survey on prevalence and risk factors for persistent postsurgical pain 1 year after total hip and knee replacement. Reg Anesth Pain Med. 2012;37:415–22.CrossRef
Metadata
Title
Expert Consensus on Clinical Use of an Orally Administered Dexketoprofen Plus Tramadol Fixed-Dose Combination in Moderate-To-Severe Acute Pain: A Delphi Study
Authors
Giustino Varrassi
Stefano Coaccioli
Josè De-Andrés
Magdi Hanna
Giorgos Macheras
Antonio Montero
Serge Perrot
Vincenzo Piras
Carmelo Scarpignato
Publication date
01-11-2019
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 11/2019
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-019-01096-0

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