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The supply of IP is disrupted
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV PCA (proportional dosage) | Active Comparator | Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15% |
|
| SL-FTN (equivalent dose for PCA bolus) | Experimental | Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Infusion | Drug | IV PCA(fentanyl) Fentanyl bolus = MME * 15% |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jee Youn Moon, MD, PhD | Seoul National University Hospital | Study Chair |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D059390 | Breakthrough Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| D010323 | Passive Cutaneous Anaphylaxis |
| D000286 | Administration, Sublingual |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Sublingual Tablet | Drug | subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement. |
|
|
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 |
| D007263 |
| Infusions, Parenteral |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D000284 | Administration, Oral |