Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Seoul National University

Overview

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.

Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cancer Pain Breakthrough Pain

Interventions

Intravenous InfusionDRUG

IV PCA(fentanyl) Fentanyl bolus = MME \* 15%

Sublingual TabletDRUG

subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in 11-point scale NRS pain score

Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"

Time frame: 30 minutes after administration

Secondary Outcomes

Change in 11-point scale NRS pain score

Time frame: 15, 45, 60 minutes after administration

sum of pain intensity difference(SPID)

sum of pain intensity change compared to baseline difference

Time frame: 60 minutes after administration

number of additional doses

number of additional doses fentanyl bolus or subligual

Time frame: immediately after the intervention

Pain interference

Pain interference using BPI-SF

Time frame: immediately after the intervention

Insomnia

The severity of insomnia using ISI

Time frame: immediately after the intervention

Depression

The severity of depression using Beck Depression Inventory(BDI) 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.