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NOT YET RECRUITING
NCT07154446
PHASE4

Study Comparing Dynastat and Parestat Pain Relief Medications for Patients After Breast Surgery

Sponsor: University of Malaya

View on ClinicalTrials.gov

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.

Official title: Dynastat vs. Parestat for Postoperative Analgesia in Breast Surgery: A Non-Inferiority Randomised Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-01

Completion Date

2026-12

Last Updated

2025-09-22

Healthy Volunteers

No

Interventions

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