Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Submuscular Breast Augmentatio

Not Applicable

• Conditions: -Z411 Other plastic surgery for unacceptable cosmetic appearance; Other plastic surgery for unacceptable cosmetic appearance; Z411

• Registration Number: PER-010-07
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>Measure:Amount of opioid analgesics administered during the first 24 hours after the first dose of the study drug.<br>Timepoints:24 hours.<br>