[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604817":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":41,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"University of Malaya","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Parestat Group, Parestat(generic parecoxib)","EXPERIMENTAL","Patients receiving IV Parestat 40mg (generic Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision.",[13],"Drug: Parestat(generic parecoxib)",{"label":15,"type":16,"description":17,"interventionNames":18},"Dynastat group, Dynastat(Original Parecoxib)","ACTIVE_COMPARATOR","Patients receiving IV Dynastat 40mg (original Parecoxib) will have it administered by an anaesthesiologist after the induction of general anaesthesia and before the surgeon makes the skin incision.",[19],"Drug: Dynastat (original Parecoxib)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Parestat(generic parecoxib)","This arm will receive IV Parestat 40mg during surgery",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Dynastat (original Parecoxib)","This arm will receive IV Dynastat 40mg during surgery",[15],[32],{"name":33,"affiliation":34,"role":35},"Ahmad Fariz Elias","Universiti Malaya","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+60194062520","fariz.elias@ummc.edu.my",{"type":35,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ahmad Fariz Bin Elias","Dr","100604817","phase-4-study-comparing-dynastat-and-parestat-pain-relief-medications-for-patients-after-breast-surgery-100604817",false,"NCT07154446","Study Comparing Dynastat and Parestat Pain Relief Medications for Patients After Breast Surgery","Dynastat vs. Parestat for Postoperative Analgesia in Breast Surgery: A Non-Inferiority Randomised Controlled Trial","PANDA","Inclusion Criteria:\n\nPatients aged 18 years or older. Patients scheduled for elective excision biopsy of the breast. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I or II.\n\nPatients who can understand and provide written informed consent.\n\nExclusion Criteria:\n\nPatients with a known allergy or contraindication to parecoxib or any of its excipients.\n\nPatients with a history of severe gastrointestinal bleeding, ulceration, or perforation.\n\nPatients with a history of significant cardiovascular disease (e.g., unstable angina, recent myocardial infarction, stroke).\n\nPatients with uncontrolled hypertension. Patients with severe renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin). Patients with severe hepatic impairment (Child-Pugh Class C). Patients who are pregnant or breastfeeding. Patients taking medications that are contraindicated with parecoxib (refer to drug interaction section).\n\nPatients with a history of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.","FEMALE","18 Years","65 Years",{"count":56,"type":57},60,"ESTIMATED","INTERVENTIONAL",[60],"PHASE4","The goal of this clinical trial is to learn if generic parecoxib (Parestat) works as well as the original drug (Dynastat) for treating pain after breast surgery. It will also learn about the safety of both drugs. The main questions it aims to answer are:\n\n* Does Parestat provide pain relief that is not inferior to the pain relief provided by Dynastat?\n* What medical problems (adverse events) do participants have when taking Parestat compared to Dynastat? Researchers will compare Parestat to Dynastat to see if the generic version also works to treat postoperative pain.\n\nParticipants will:\n\n* Be randomly assigned to receive either Dynastat or Parestat during their surgery.\n* Have their pain level assessed using the Visual Analog Scale (VAS) upon arrival in the recovery bay, 6 and 24 hours after surgery.\n* Be monitored for common side effects like nausea, vomiting, and changes in blood pressure for 24 hours.",[63],"Breast Exicision Biopsy",[65,66,67],"Randomised control trial","parecoxib","Breast excision biopsy","NOT_YET_RECRUITING","2025-09-16",{"date":71,"type":72},"2025-09-22","ACTUAL",{"date":74,"type":57},"2025-10-01",{"date":76,"type":57},"2026-12",{"name":5,"class":6}]