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| ID | Type | Description | Link |
|---|---|---|---|
| NMCH2007-241 |
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With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Placebo Comparator | No drug was delivered. |
|
| II | Active Comparator | Butorphanol tartrate 1mg was given intravenously. |
|
| III | Active Comparator | Butorphanol tartrate 2 mg was given intravenously. |
|
| IV | Active Comparator | Flurbiprofen Axetil 50 mg was given intravenously. |
|
| V | Active Comparator | Flurbiprofen Axetil 100 mg was given intravenously. |
|
| VI | Active Comparator | Tramadol Hydrochloride 10 mg was given intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Saline 5 ml administrated intravenously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) rating of pain | 0-24h after surgeries |
| Measure | Description | Time Frame |
|---|---|---|
| VAS rating of sedation | 0h to 24h after the end of the operation | |
| Overall VAS rating of satisfaction with analgesia | 24 h after operation | |
| Incidence of side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XiaoFeng Shen, MD | Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternal and Child Care Hospital | Nanjing | Jiangsu | 210004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18622068 | Result | Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001943 | Breast Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000701 | Analgesics, Opioid |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| VII |
| Active Comparator |
Tramadol Hydrochloride 20 mg was given intravenously. |
|
| Opioid | Drug | Butorphanol tartrate 1 mg i.v. |
|
|
| Opioid | Drug | Butorphanol Tartrate 2 mg i.v. |
|
|
| NSAID | Drug | Flurbiprofen Axetil 50 mg i.v. |
|
|
| NSAID | Drug | Flurbiprofen Axetil 100 mg i.v. |
|
|
| Opioid | Drug | Tramadol Hydrochloride 10 mg i.v. |
|
|
| Opioid | Drug | Tramadol Hydrochloride 20 mg i.v. |
|
|
| From the initiation of analgesia (0 h) to the end of the study (24 h postoperative) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D017670 |
| Sodium Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D018712 | Analgesics, Non-Narcotic |
| D000893 | Anti-Inflammatory Agents |
| D018501 | Antirheumatic Agents |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |