drugset / Trial / NCT05825495

Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

NCT05825495

Phase 4 Unknown 78 enrolled Li-Jen Hsin
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-05-01
Primary completion
2024-04-23
Completion
2024-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dinalbuphine sebacate Small molecule 150 mg Other