About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Parestat(generic parecoxib)
DrugThis arm will receive IV Parestat 40mg during surgery
Dynastat (original Parecoxib)
DrugThis arm will receive IV Dynastat 40mg during surgery
Treatment groups
Trial outcomes
Primary outcomes
Pain Score
Each participant's pain score will be assessed using the Numeric Rating Scale (NRS) at three time points: upon arrival in the recovery bay, before discharge from the recovery bay, and 24 hours postoperatively. The NRS ranges 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Highest score reflect worst outcome
Secondary outcomes
Adverse events
To detect and compare the incidence of common adverse events between the two groups, specifically: * Nausea and vomiting, constipation * Changes in blood pressure, differences 20% from baseline (increase or decrease) * Edema * Pruritus * Gastritis * Bronchospasm
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: