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The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general anesthesia.
In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flurbiprofen axetil | Active Comparator | flurbiprofen axetil intraoperative administration 100mg |
|
| nalbuphine | Experimental | nalbuphine intraoperative administration 0.1mg/kg |
|
| nalbuphine and flurbiprofen axetil | Experimental | flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine | Drug | Nalbuphine administration during surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain 24 hours after recovery | Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5). | 24 hours after recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort 24 hours after recovery | Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huijing Ye | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| C504422 | flurbiprofen axetil |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Flurbiprofen Axetil |
| Drug |
Flurbiprofen axetil administration during surgery |
|
| Nalbuphine and Flurbiprofen Axetil | Drug | Nalbuphine and Flurbiprofen Axetil administration during surgery |
|
| 24 hour after recovery |
| D010335 | Pathologic Processes |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |