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To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.
This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naldebain | Experimental | Subjects will receive one dose of Naldebain before surgery. |
|
| Morphine | Active Comparator | Subjects will receive morphine after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naldebain | Drug | 150 mg Nalbuphine sebacate |
| |
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain) | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of supplemental analgesics | Sum of supplemental analgesics | From Day 0 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event | Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness) | From Day 0 to Day 3 |
| Percentage of Patient satisfaction | Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sing-Ong Lee, MD | Cathay General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cathay General Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32982387 | Derived | Lee SO, Huang LP, Wong CS. Preoperative Administration of Extended-Release Dinalbuphine Sebacate Compares with Morphine for Post-Laparoscopic Cholecystectomy Pain Management: A Randomized Study. J Pain Res. 2020 Sep 9;13:2247-2253. doi: 10.2147/JPR.S263315. eCollection 2020. |
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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 |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
Morphine |
|
| Day 3 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| 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 |