Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Seoul National University

Status: Withdrawn

Conditions: Cancer Pain; Breakthrough Pain

Treatments: Drug: Intravenous Infusion; Drug: Sublingual Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05053308

2012-144-1183

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

IV PCA (proportional dosage)

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Infusion

SL-FTN (equivalent dose for PCA bolus)

Experimental group

Description:

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

Treatment:

Drug: Sublingual Tablet