{"id":"dexketoprofen-trometamol-tramadol-hydrochloride","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"}]},"_chembl":{"chemblId":"CHEMBL1237065","moleculeType":"Small molecule","molecularWeight":"299.84"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dexketoprofen trometamol is the active S-enantiomer of ketoprofen that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation, pain, and fever. Tramadol hydrochloride is a synthetic opioid that acts as a mu-receptor agonist and also inhibits the reuptake of norepinephrine and serotonin, providing multimodal analgesia. Together, they provide synergistic pain relief for moderate to moderately severe acute pain.","oneSentence":"This combination product uses dexketoprofen (a nonsteroidal anti-inflammatory drug) to reduce inflammation and pain, and tramadol (an opioid analgesic) to provide additional pain relief through multiple mechanisms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:44:26.876Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to moderately severe acute pain"}]},"trialDetails":[{"nctId":"NCT05170841","phase":"PHASE4","title":"Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain","status":"COMPLETED","sponsor":"Menarini International Operations Luxembourg SA","startDate":"2020-09-17","conditions":"Low Back Pain","enrollment":538},{"nctId":"NCT02777970","phase":"PHASE4","title":"Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar","status":"COMPLETED","sponsor":"Menarini Group","startDate":"2016-04","conditions":"Acute Pain","enrollment":654},{"nctId":"NCT04178109","phase":"PHASE2","title":"Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.","status":"COMPLETED","sponsor":"KAT General Hospital","startDate":"2019-01-10","conditions":"Postoperative Pain, Pain, Acute","enrollment":226},{"nctId":"NCT01904149","phase":"PHASE3","title":"Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride","status":"COMPLETED","sponsor":"Menarini Group","startDate":"2013-05","conditions":"Acute Pain","enrollment":606},{"nctId":"NCT01902134","phase":"PHASE3","title":"Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride","status":"COMPLETED","sponsor":"Menarini Group","startDate":"2013-04","conditions":"Acute Pain","enrollment":641},{"nctId":"NCT01307020","phase":"PHASE2","title":"Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain","status":"COMPLETED","sponsor":"Menarini Group","startDate":"2011-02","conditions":"Pain","enrollment":745},{"nctId":"NCT01558622","phase":"PHASE4","title":"Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication","status":"UNKNOWN","sponsor":"Kavaklıdere Umut Hospital","startDate":"2012-03","conditions":"Laparoscopic Nissen Fundoplication","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"dexketoprofen trometamol + tramadol hydrochloride","genericName":"dexketoprofen trometamol + tramadol hydrochloride","companyName":"Kavaklıdere Umut Hospital","companyId":"kavakl-dere-umut-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination product uses dexketoprofen (a nonsteroidal anti-inflammatory drug) to reduce inflammation and pain, and tramadol (an opioid analgesic) to provide additional pain relief through multiple mechanisms. Used for Moderate to moderately severe acute pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}