Breakthrough Pain, Cancer Pain
Conditions
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.
Interventions
DRUGIntravenous Infusion
IV PCA(fentanyl) Fentanyl bolus = MME \* 15%
subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
Sponsors
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| sum of pain intensity difference(SPID) | 60 minutes after administration | sum of pain intensity change compared to baseline difference |
| number of additional doses | immediately after the intervention | number of additional doses fentanyl bolus or subligual |
| Pain interference | immediately after the intervention | Pain interference using BPI-SF |
| 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 |
| 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 |
| Insomnia | immediately after the intervention | The severity of insomnia using ISI |
Outcome results
None listed