Overview

Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Status:
Not yet recruiting
Trial end date:
2022-09-15
Target enrollment:
0
Participant gender:
All
Summary
Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University
Criteria
Inclusion Criteria:

- Age 19-80

- Cancer pain

- Admission for the control of cancer pain or consultation for the treatment of cancer
pain

- Stable vital sign

- ECOG status ≤ 3 for more than 1 or 2 months

- Opioid-tolerant state

- No history of using sublingual fentanyl

Exclusion Criteria:

- Noncancer pain

- Opioid naive

- baseline NRS pain score> 4

- Current using sublingual fentanyl

- Difficult to assess cancer pain

- no evidence of disease(cancer)

- Planned surgical resection of cancer

- Allergy to fentanyl

- Severe renal and/or liver function

- Severe respiratory depression or uncontrolled COPD