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Randomized control trial that to comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Primary outcome : to measure pain score after drug is given
objective; To comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Population : gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain and had experienced of breakthrough pain cancer in Rajavithi hospital sample size : 20 person/group Method ; Randomized control trial , Prospective Intervention : group A : injectable fentanyl in sublingual , group B : oral morphine syrup Primary outcome : to measure pain score after drug is given at 5, 15, 30, 45, 60 and 120 min secondary outcome : to record side effect of drug is given at 5, 15, 30, 45, 60 and 120 min Statistical method
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable Fentanyl in Sublingual Route | Experimental | Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route |
|
| Oral Morphine Syrup | Active Comparator | Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Citrate 50Mcg/Ml Inj_#1 | Drug | Injectable Fentanyl in Sublingual Route 50 mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | measure with numeric score from 0-10 point (maximum pain= 10 point) | after drug is given at 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Neausea and vomiting | measure by asking symptom from patient | after drug is given at 5 minutes |
| Ithching | measure by asking symptom from patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thanvarat Tilagul | Department of Medical Services Ministry of Public Health of Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15676050 | Background | Lennernas B, Hedner T, Holmberg M, Bredenberg S, Nystrom C, Lennernas H. Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: a new approach to treatment of incident pain. Br J Clin Pharmacol. 2005 Feb;59(2):249-53. doi: 10.1111/j.1365-2125.2004.02264.x. | |
| 10353500 |
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| ID | Term |
|---|---|
| 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 |
|---|---|
| D005283 | Fentanyl |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
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| Morphine | Drug | Oral Morphine Syrup 2.5 ml ( 5 mg) |
|
|
| after drug is given at 5 minutes |
| Respiratory distress | measure by respiratory rate parametor | after drug is given at 5 minutes |
| Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999 May;81(1-2):129-34. doi: 10.1016/s0304-3959(99)00006-8. |
| 18258412 | Result | Zeppetella G. Opioids for cancer breakthrough pain: a pilot study reporting patient assessment of time to meaningful pain relief. J Pain Symptom Manage. 2008 May;35(5):563-7. doi: 10.1016/j.jpainsymman.2007.06.012. Epub 2008 Feb 6. |
| 21215653 | Result | Mercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011 Dec;80(3):460-5. doi: 10.1016/j.critrevonc.2010.12.002. Epub 2011 Jan 6. |
| 23380337 | Result | Jandhyala R, Fullarton JR, Bennett MI. Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials. J Pain Symptom Manage. 2013 Oct;46(4):573-80. doi: 10.1016/j.jpainsymman.2012.09.009. Epub 2013 Feb 4. |
| 24385406 | Result | Velazquez Rivera I, Munoz Garrido JC, Garcia Velasco P, Espana Ximenez de Enciso I, Velazquez Clavarana L. Efficacy of sublingual fentanyl vs. oral morphine for cancer-related breakthrough pain. Adv Ther. 2014 Jan;31(1):107-17. doi: 10.1007/s12325-013-0086-4. Epub 2014 Jan 3. |
| 19508134 | Result | Bushnaq M, Al-Shoubaki M, Milhem M. The feasibility of using intravenous fentanyl as sublingual drops in the treatment of incidental pain in patients with cancer. J Palliat Med. 2009 Jun;12(6):511-4. doi: 10.1089/jpm.2009.9618. No abstract available. |
| 37170709 | Derived | Thantiprechapong T, Tilagul T, Vasikasin V. Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial. J Obstet Gynaecol Res. 2023 Jul;49(7):1815-1820. doi: 10.1111/jog.15674. Epub 2023 May 11. |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |