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This is a randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (DS) on patients having uvulopalatopharyngoplasty (UPPP). DS is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. The mean absorption time for the complete release of DS into systemic circulation is approximately 145 h, which could theoretically provide extended analgesic effects for up to 6 days. Patients diagnosed with obstructive sleep apnea are generally associated with higher risks towards opioid side effects, especially respiratory depression. Post-UPPP pain managing should be cautiously arranged and executed. We hypothesize that the combination of our routine practice and DS will improve the outcomes after Uppp.
Within 4 weeks before uvulopalatopharyngoplasty, patients are invited for this study. After written informed consent gained, the eligibilities are checked. Eligible patients are arrogated into experimental or control group randomly prior to surgery. Experimental group receives the DS administration at least 12 hours before surgery. During peri-operative period, pain management are conducted following our routine practice. Pain intensity, consumption of analgesics, adverse events, swallow function and life quality are all assessed and recorded within 14 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Subjects will intragluteally injected with a dose of 150 mg dinalbuphine sebacate at least 12 hours before surgery. During intra- and post-operative period, the pain management will execute following our routine practice. |
|
| Control group | Sham Comparator | The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinalbuphine sebacate | Drug | A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged. | within 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged. | within 14 days after surgery |
| Consumption of analgesics | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li-Jen Hsin, MD | Contact | 886-3-3281200 | 8466 | lijen.hsin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Li-Jen Hsin, MD | Linkou Chang Gung Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Routine practice | Other | Within 3 days after surgery, paracoxib will be administrated twice a day. Ketorolac will intravenously give once breakthrough pain occurring. Enteral acetaminophen will be take regularly within 14 days after surgery. |
|
| within 3 days after surgery |
| Consumption of analgesics | Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated. | within 14 days after surgery |
| Percentage of patients consuming analgesics | Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated. | within 3 days after surgery |
| Incidence of adverse events | Percentage and number of patients suffering from adverse events will be summarized by the individual days. | within 3 days after surgery |
| Incidence of adverse events | Percentage and number of patients suffering from adverse events will be summarized by the individual days. | within 14 days after surgery |
| EAT-10 (Eating Assessment Tool) | EAT-10 is a dysphagia assessment that helps to measure swallowing difficulties. There are 10 questions in the questionnaire. Each question has 5 levels, 0 means no problem and 4 means severe problem. | 1 day, 3 days, 7 days and 14 days after surgery |
| MD Anderson Dysphagia Inventory | The MDADI is the first validated and reliable self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the QOL of patients with head and neck cancer. There are 20 questions in the questionnaire. Each question has five levels, including strongly disagree, disagree, no opinion, agree, strongly agree. | 1 day, 3 days, 7 days and 14 days after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |