Status:
NOT_YET_RECRUITING
Study Comparing Dynastat and Parestat Pain Relief Medications for Patients After Breast Surgery
Lead Sponsor:
University of Malaya
Conditions:
Breast Exicision Biopsy
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
The goal of this clinical trial is to determine whether generic parecoxib (Parestat) is as effective as the original parecoxib (Dynastat) for treating pain following breast surgery. The trial will als...
Eligibility Criteria
Inclusion
- Patients 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.
- Patients who can understand and provide written informed consent.
Exclusion
- Patients with a known allergy or contraindication to parecoxib or any of its excipients.
- Patients with a history of severe gastrointestinal bleeding, ulceration, or perforation.
- Patients with a history of significant cardiovascular disease (e.g., unstable angina, recent myocardial infarction, stroke).
- Patients with uncontrolled hypertension. Patients with severe renal impairment (creatinine clearance \< 30 mL/min). 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).
- Patients with a history of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07154446
Start Date
October 1 2025
End Date
December 1 2026
Last Update
September 22 2025
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