Postoperative Pain Management on Uvulopalatopharyngoplasty Patients

NCT05825495 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-04-25

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825495 on ClinicalTrials.gov