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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.
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.
Pain intensity
Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
Time frame: within 3 days after surgery
Pain intensity
Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.
Time frame: within 14 days after surgery
Consumption of analgesics
Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
Time frame: within 3 days after surgery
Consumption of analgesics
Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day, 3 days, 7 days and 14 days after surgery
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