None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with: Parecoxib, in vials of 40 mg in 5 ml, at a dose of 40 mg, IV, before the start of surgery + Parecoxib, at a dose of 40 mg, IM, 6-12 hours after the first dose
Group name:GROUP 2 Type of group
This group will be treated with: Parecoxib Placebo, in vials of 5ml, IV, before the start of surgery + Parecoxib Placebo, in vials, IM, 6-12 hours after the first dose.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients of any ethnicity 18 years of age or older. 2. The patient is postmenopausal, surgically sterile, or must be using adequate contraceptive methods. 3. The patient should weigh 50 to 120 kg. 4. The patient needs an elective transaxillary subpectoral augmentation mammoplasty. 5. The patient has given the responsible surgeon a written informed consent on the specific surgical procedure. 6. The pre-operative health of the patient must have a class I or II degree according to the physical condition classification of the ASA. 7. The patient must agree to remain in the hospital or clinic until at least 24 hours after the first dose of the study medication and complete the safety and pain assessments of the protocol at least 24 hours after administration of the medication. The first dose of medication is study. 8. The patient has given written informed consent before the start of this study.
Exclusion criteria
Exclusion criteria: 1. The patient has significant clinical signs and symptoms suggesting morbid kidney or liver conditions. 2. In addition to the transaxillary subpectoral augmentation mammoplasty, the patient will undergo any other surgery during the same procedure. 3. The patient has been a recipient of a kidney, liver or heart transplant. 4. The patient is being treated for any kind of infection or has clinical suspicion of infection. 5. The patient is currently receiving anticoagulants. 6. The patient has a coagulopathy, which in the opinion of the researcher is considered clinically significant. 7. The patient has a fever and / or an infection. 8. The patient has a history of active peptic ulceration, active dyspepsia, gastrointestinal, esophageal and gastric bleeding, or duodenal ulcer within one month before the screening evaluation. 9. The patient has a history of abuse of alcoholic, analgesic or narcotic substances within one month before the screening evaluation visit. 10. The patient has any cognitive dysfunction that could prevent her participation in the study or compliance with the procedures mandated by the protocol. 11. The patient has a history of clinically significant hypersensitivity to any NSAID, cyclooxygenase inhibitors, analgesics or sulfa drugs that have a cross-sensitivity with the medications used in this study. 12. The patient has a history of uncontrolled chronic disease, which could contraindicate participation in the study or confuse the interpretation of the results. 13. Chronic pain condition that requires chronic treatment and / or which may affect pain assessments or response to therapy. 14. The patient has a clinically and significantly reduced volume. 15. The patient used analgesics or other agents during the 4 hours that precede the procedure that could confuse the analgesic responses. 16. Within one year before the screening evaluation, the patient has been diagnosed with, treated for, or does not have remission of any cancer other than basal cell carcinoma. 17. The patient has received any investigational medication within one month prior to the administration of the study medication or is scheduled to receive any investigational drug other than parecoxib during the course of this study. 18. The patient has been previously admitted in this study. 19. Patients with a history of established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease, as well as subjects with prior coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature revascularization procedures. 20. Other chronic or acute severe medical or psychiatric conditions or abnormalities in laboratory tests that may increase the risk associated with participation in the trial or administration of the investigational product or that may interfere with the interpretation of trial results and , in the opinion of the researcher, could make the patient not appropriate to enter this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It will be calculated as the amount of morphine administered plus the dose of fentanyl equivalent to morphine plus the dose of tramadol equivalent to morphine. Measure:Amount of opioid analgesics administered during the first 24 hours after the first dose of the study drug. Timepoints:24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1, 2 and 3: Analogous Visual Scale of Pain Intensity (PI-VAS), which is a horizontal line of 100 mm, whose left end represents No pain and its right end represents Worst possible pain. Criterion 4: Identification of the use of morphine. Criterion 5: Categorical scale of 4 points, in which the patient qualifies the study medication received for the pain (1 = Poor, 2 = Regular, 3 = Good and 4 = Excellent). Criterion 6: Categorical scale of 4 points, in which the researcher qualifies the study medication received for the pain (1 = Poor, 2 = Regular, 3 = Good and 4 = Excellent). Criterion 7: Determination of the moment in which the rescue medication is administered. Criterion 8: OR-SDS will evaluate 10 common symptoms related to opioids, in 3 ordinal measurements: frequency, severity, and nuisance. Criterion 9: m-BPI-sf is a self-administered questionnaire that evaluates the severity of pain and the interference of functional activities. Criterion 10: Number of hours between T0 and the time when the patient is discharged from the PACU. Criterion 11: Number of hours from admission to hospital discharge. Criterion 12: High Post-Anesthesia Evaluation System (PADS), based on five criteria: vital signs, walking ability, nausea / vomiting, pain and surgical bleeding. Measure:Secondary Efficacy: 1) Specific Pain Intensity. 2) Intensity of Pain Summed over 6 hours (SPI6) and 24 hours (SPI24). 3) Intensity of Pain when the patient is placed in a sitting position. 4) Proportion of patients using IV morphine. 5) Overall evaluation of the patient. 6) Overall clinical evaluation of the patient after the first dose of drug. 7) Time to take the rescue medication. 8) Scale of Distressing Symptoms (OR-SDS) related to opioids. 9) Modified brief pain inventory-short format (m-BPI-sf). 10) Time of stay in the post-anesthesia care unit. 11) Length of stay in the hospital. 12) Time it took to be ready to be discharged. Timepo | — |
Outcome results
None listed