Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain
NCT ID: NCT05037539
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2021-06-15
2022-06-30
Brief Summary
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Detailed Description
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* Categorical data = Chi-square test or Fishers' exact test
* Continuous data : comparison with Student t-test in normal deviation data and Man-Whitney U- test in abnormal deviation data • Analytical data with Pearson's correlation, Linear regression or Binary Logistic regression, Repeated Measures ANOVA with OR (95%CI) and p-value \<0.05
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Injectable Fentanyl in Sublingual Route
Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route
Fentanyl Citrate 50Mcg/Ml Inj_#1
Injectable Fentanyl in Sublingual Route 50 mcg
Oral Morphine Syrup
Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred
Morphine
Oral Morphine Syrup 2.5 ml ( 5 mg)
Interventions
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Fentanyl Citrate 50Mcg/Ml Inj_#1
Injectable Fentanyl in Sublingual Route 50 mcg
Morphine
Oral Morphine Syrup 2.5 ml ( 5 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* abnormal cognitive function patient
FEMALE
No
Sponsors
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Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
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Principal Investigators
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Thanvarat Tilagul
Role: STUDY_DIRECTOR
Department of Medical Services Ministry of Public Health of Thailand
Locations
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Rajavithi Hospital
Bangkok, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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090/2564
Identifier Type: -
Identifier Source: org_study_id
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