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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Malaya

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parestat(generic parecoxib)

    Drug

    This arm will receive IV Parestat 40mg during surgery

  • Dynastat (original Parecoxib)

    Drug

    This arm will receive IV Dynastat 40mg during surgery

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Parestat Group, Parestat(generic parecoxib)Experimental treatment 1 intervention
Group B: Dynastat group, Dynastat(Original Parecoxib)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours after surgery completed

Secondary outcomes

1

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

Time frame
24 hours after completion of surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: