Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial

Conditions
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Cancer Pain, Breakthrough Pain

Intervention / Treatment
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* Drug: Intravenous Infusion
* Drug: Sublingual Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV PCA (proportional dosage)<br>Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15% | Drug: Intravenous Infusion<br>* IV PCA(fentanyl) Fentanyl bolus = MME * 15%<br>* Other names: PCA;|
| Experimental: SL-FTN (equivalent dose for PCA bolus)<br>Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement. | Drug: Sublingual Tablet<br>* subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.<br>* Other names: sublingual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 15, 45, 60 minutes after administration | 
| sum of pain intensity difference(SPID) | sum of pain intensity change compared to baseline difference | 60 minutes after administration | 
| number of additional doses | number of additional doses fentanyl bolus or subligual | immediately after the intervention | 
| Pain interference | Pain interference using BPI-SF | immediately after the intervention | 
| Insomnia | The severity of insomnia using ISI | 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 | immediately after the intervention | 
| Satisfaction scale | Satisfaction check using 5 Likert-scale (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied | immediately after the intervention |