Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
NCT05825495 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2023-04-25
Summary
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.
Conditions
- Pain, Postoperative
- Obstructive Sleep Apnea-hypopnea Syndrome
- Pain, Acute
Interventions
- DRUG
-
Dinalbuphine sebacate
A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.
- OTHER
-
Routine practice
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.
Sponsors & Collaborators
-
Li-Jen Hsin
lead OTHER
Principal Investigators
-
Li-Jen Hsin, MD · Linkou Chang Gung Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2024-04-23
- Completion
- 2024-05-01
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