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

NCT07154446 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Breast Exicision Biopsy

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

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Ahmad Fariz Elias · Universiti Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-08-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154446 on ClinicalTrials.gov