Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Not Applicable

Withdrawn

• Conditions: Cancer Pain; Breakthrough Pain
• Interventions: Drug: Sublingual Tablet; Drug: Intravenous Infusion

• Registration Number: NCT05053308
• Lead Sponsor: Seoul National University

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-22
• Study Start: 2022-12-01
• Primary Completion: 2023-05-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SL-FTN (equivalent dose for PCA bolus)	Sublingual Tablet	Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
IV PCA (proportional dosage)	Intravenous Infusion	Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME \* 15%

Primary Outcome Measures

Name	Time	Method
Change in 11-point scale NRS pain score	30 minutes after administration	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"

Secondary Outcome Measures

Name	Time	Method
number of additional doses	immediately after the intervention	number of additional doses fentanyl bolus or subligual
sum of pain intensity difference(SPID)	60 minutes after administration	sum of pain intensity change compared to baseline difference
Pain interference	immediately after the intervention	Pain interference using BPI-SF
Insomnia	immediately after the intervention	The severity of insomnia using ISI
Depression	immediately after the intervention	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
Satisfaction scale	immediately after the intervention	Satisfaction check using 5 Likert-scale; (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied
Change in 11-point scale NRS pain score	15, 45, 60 minutes after administration	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"