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The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM versus placebo on reducing postoperative acute pain following submuscular breast augmentation. Additionally this study is being conducted to evaluate the safety and tolerability of parecoxib in this kind of procedure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARECOXIB SODIUM | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the opioid-sparing effect of parecoxib 40 mg IV/IM compared to placebo in pre emptive analgesia in patients submitted to sub muscular breast augmentation during the first 24 hours after the first dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of pain intensity | ||
| To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of global evaluation of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
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| To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of vital signs |
| To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of coagulation tests |
| To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of adverse events |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |