A Phase 1/2 interventional study of Fentanyl Citrate 50Mcg/Ml Inj_#1 and Morphine in Pain, Breakthrough, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Completed at 1 site in Thailand. Open to female participants. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Phase 1/2, Interventional, and Supportive care
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
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 20 is below the median of 91 across 21 interventional studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route
Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1
Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred
Drug: Morphine
Pain score
measure with numeric score from 0-10 point (maximum pain= 10 point)
Time frame: after drug is given at 5 minutes
Neausea and vomiting
measure by asking symptom from patient
Time frame: after drug is given at 5 minutes
Ithching
measure by asking symptom from patient
Time frame: after drug is given at 5 minutes
Respiratory distress
measure by respiratory rate parametor
Time frame: after drug is given at 5 minutes
Plan to share: No
Ran from Jun 2021 to primary completion in Dec 2021, 6 months.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fentanyl
Department of Medical Services Ministry of Public Health of Thailand