Delving into the Latest Updates on Dexketoprofen Trometamol/Tramadol Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DKP.TRIS/TRAM, DKP.TRIS/TRAM.HCL, DKP/TRAM

+ [11]

Target

COX-1 x COX-2 x μ opioid receptor

Mechanism

COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System Diseases

Active Indication

Acute Pain

Inactive Indication

Acute low back pain

Originator Organization

A. Menarini Industrie Farmaceutiche Riunite SRL

Active Organization

Menarini Ricerche SpA

A. Menarini Industrie Farmaceutiche Riunite SRL

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

ES (20 Dec 2015),

Acute Pain

Regulation-

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Structure

Molecular FormulaC16H26ClNO2

InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N

CAS Registry36282-47-0

View All Structures (2)

Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).

Start Date10 Jan 2019

Sponsor / Collaborator-

NCT02777970 / CompletedPhase 4

Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)

The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

Start Date01 Apr 2016

Sponsor / Collaborator

A. Menarini Industrie Farmaceutiche Riunite SRL

100 Clinical Results associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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100 Translational Medicine associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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100 Patents (Medical) associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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5

Literatures (Medical) associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

01 Mar 2024·BMJ Open

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Article

Author: Raju, Gopinathan ; Eufemio, Edgar Michael ; Ho, Kok Yuen ; Roohi, Sharifah Ahmad ; Dimayuga, Cesar ; Waithayayothin, Kritsadakorn ; Sawaddiruk, Passakorn ; Gupta, Ankur ; Chong, Keen Wai ; Castro, Marc Anthony L ; Bernardo, Edwin ; Wilairatana, Vajara ; Oon, Zhi Hao ; Nagrale, Dinesh ; Tangwiwat, Suwimon ; Salvador, Roehl C ; Gyanwali, Bibek ; Ona, Leonardo

IntroductionSatisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.Methods and analysisREKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.Ethics and disseminationThe study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

01 Sep 2022·Nigerian Journal of Clinical Practice

Posterior Quadratus Lumborum Block Versus Posterior Transversus Abdominis Plane Block for Unilateral Inguinal Hernia Surgery

Article

Author: Ergil, J ; Altinsoy, S ; Ozhan, M O ; Akelma, F K ; Caparlar, C O

Background:Ultrasound-guided truncal nerve blocks are increasingly used for postoperative pain relief after abdominal surgery.Aim:The aim of this prospective and randomized study was to compare posterior transversus abdominis plane block (pTAPB) with posterior quadratus lumborum block (pQLB) for postoperative analgesic efficacy in patients undergoing unilateral inguinal hernia surgery under general anesthesia (GA).Patients and Methods:A total of 90 adult patients were randomized into 3 groups: group pTAPB (n = 30), group pQLB (n = 30), and group Control (n = 30). The patients in groups pQLB and pTAPB received a unilateral block using 20 ml of 0.25% bupivacaine after the induction of GA. Intravenous (IV) tramadol patient control group analgesia (PCA) and paracetamol were used in the postoperative period as a part of the multimodal analgesic regimen in both groups. Postoperative pain was assessed using a visual analog scale (VAS) during postoperative 24 h. Dexketoprofene was used as a rescue analgesic when VAS is >3. The primary outcome measure was mean pain scores. Secondary outcome measures were consumption of rescue analgesics and the amount of tramadol delivered by PCA. P <0.05 was considered statistically significant.Results:Mean VAS scores were significantly lower in the group pQLB than group pTAPB and group Control at all-time points (pQLB < pTAPB < Control; P < 0.001). Rescue analgesic was not required in group QLB. Rescue analgesic consumption, the number of bolus demand on PCA, and total PCA dose were highest in group Control and lowest in the pQLB group (Control > pTAPB > pQLB; P < 0.001).Conclusion:It is concluded that both pQLB and pTAPB provided effective pain relief after unilateral inguinal hernia surgery. pQLB was superior to pTAPB due to lower pain scores and analgesic consumption.

01 Jun 2018·Drug and Therapeutics Bulletin

What place is there for tramadol/dexketoprofen?

Article

No single analgesic provides effective pain relief in all patients and increasing the dose of an analgesic may increase its unwanted effects.1 In addition, pain frequently results from multiple mechanisms that may respond to different pharmacological interventions.2 One suggested approach is to combine analgesics with different modes of action, with the aim of delivering better analgesia using lower doses of each drug.1 Skudexa (A. Menarini Farmaceutica Internazionale SRL), a combination of tramadol hydrochloride (a synthetic opioid analgesic that is a partial agonist at the μ, δ and κ opioid receptors) and dexketoprofen (a NSAID), is licensed for short term treatment of moderate to severe acute pain in adults.1-4 Here, we consider the evidence for this product and how it fits with current guidance on the management of pain.

100 Deals associated with Dexketoprofen Trometamol/Tramadol Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	M02AA27 M01AE17	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Pain	ES	Menarini Ricerche SpA	20 Dec 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02777970 (DAVID, CTgov)	Phase 4	Acute Pain	654	Placebo+Tramadol Hydrochloride/Dexketoprofen Trometamol (Tramadol/Dexketoprofen)	rtvofsrrcj(kjasxjijdw) = zxrixjehvj emctnvbzvl (agyawxffga, gyzesfxlsz - ajwmrxjoha) View more	-	24 Mar 2021
				Placebo+Tramadol Hydrochloride/Paracetamol (Tramadol/Paracetamol)	rtvofsrrcj(kjasxjijdw) = wdlswvyebc emctnvbzvl (agyawxffga, ohsvoshlvg - ctiouzgkhm) View more
NCT01902134 \| EUCTR2012-004548-31-CZ (Pubmed \| Vet Anaesth Analg)	Phase 3	Severe pain \| Moderate pain	641	Dexketoprofen/tramadol 25 mg/75 mg	egsebtnjyl(omizqichay): P-Value = 0.019	Positive	01 Feb 2016
				Dexketoprofen 25 mg
NCT01904149 (DAVID lap, CTgov)	Phase 3	Acute Pain \| Pain, Postoperative	606	Dexketoprofen/Tramadol-single dose (DKP/TRAM Followed by DKP/TRAM)	tjfpaifdzo(bxqgfctgrv) = yssynzylkz cofzbhhlpt (qdnycparzj, woooiywrgo - wchakiucjy) View more	-	01 Apr 2015
				Dexketoprofen-single dose (DKP Followed by DKP)	tjfpaifdzo(bxqgfctgrv) = auehuvitso cofzbhhlpt (qdnycparzj, jxbkvbxova - dgesbzgtfu) View more
NCT01902134 (DAVID-art, CTgov)	Phase 3	Acute Pain \| Pain, Postoperative	641	Dexketoprofen/Tramadol-single dose (DKP/TRAM Followed by DKP/TRAM)	cqbrrcwzgf(nehkxdfurp) = ewmaqdxjdt xkjtkorpvo (sbdwkiksbw, yxpbuedrko - csmkwokxpc) View more	-	01 Apr 2015
				Dexketoprofen-single dose (DKP Followed by DKP)	cqbrrcwzgf(nehkxdfurp) = ckpmathxdm xkjtkorpvo (sbdwkiksbw, wpxuoikfxr - naxpvlbjmh) View more