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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 both drugs. The main questions it aims to answer are: * Does Parestat provide pain relief that is not inferior to the pain relief provided by Dynastat? * 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. Participants will: * Be randomly assigned to receive either Dynastat or Parestat during their surgery. * Have their pain level assessed using the Visual Analog Scale (VAS) upon arrival in the recovery bay, 6 and 24 hours after surgery. * Be monitored for common side effects like nausea, vomiting, and changes in blood pressure for 24 hours.

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 also assess the safety of both medications. The main questions it aims to answer are: 1. Does generic parecoxib (Parestat) provide the same level of pain relief as original parecoxib (Dynastat) after breast biopsy surgery? 2. What side effects do participants experience when taking either medication? Researchers will compare Parestat to Dynastat to see if the generic version is equally effective for managing postoperative pain. Participants in the study will: * Receive either Parestat or Dynastat during their breast excision biopsy surgery. * Have their pain levels measured using a pain scale at three time points: in the recovery room, before transferring to the ward, and 24 hours after surgery. * Be monitored for side effects such as nausea, changes in blood pressure, swelling, and other adverse reactions for 24 hours. * Be kept unaware of which medication they received (double-blind study design). The study will involve 60 adult women undergoing elective breast biopsy surgery, with 30 participants in each treatment group.t group.

Conditions

• Breast Exicision Biopsy

Interventions

Type	Name	Description
DRUG	Parestat(generic parecoxib)	This arm will receive IV Parestat 40mg during surgery
DRUG	Dynastat (original Parecoxib)	This arm will receive IV Dynastat 40mg during surgery

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-08-31
• Completion: 2026-12-01
• First posted: 2025-09-04
• Last updated: 2025-09-22