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 * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
20
Injectable Fentanyl in Sublingual Route 50 mcg
Oral Morphine Syrup 2.5 ml ( 5 mg)
Rajavithi Hospital
Bangkok, Thailand
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
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