Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

NCT ID: NCT05053308

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-12-31

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.

Conditions

Cancer Pain; Breakthrough Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV PCA (proportional dosage)

Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME \* 15%

Group Type: ACTIVE_COMPARATOR

Intravenous Infusion

Intervention Type: DRUG

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

SL-FTN (equivalent dose for PCA bolus)

Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Group Type: EXPERIMENTAL

Sublingual Tablet

Intervention Type: DRUG

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

Interventions

Intravenous Infusion

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

Intervention Type: DRUG

Sublingual Tablet

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

Intervention Type: DRUG

Other Intervention Names

PCA; sublingual

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University

OTHER

Sponsor Role: lead

Responsible Party

Jeeyoun Moon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jee Youn Moon, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Other Identifiers

2012-144-1183

Identifier Type: -

Identifier Source: org_study_id