PER-010-07
Completed
未知
A Double-Blind Comparative Multicenter Study Of The Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo On Reducing Opioids Consumption Following Submuscular Breast Augmentation Surgery
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -Z411 Other plastic surgery for unacceptable cosmetic appearance
- Sponsor
- PFIZER S.A.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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