Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain in Gynecologic Cancer Patients With Chronic Cancer Pain : A Randomized Double Blind Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Rajavithi Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pain score
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain
Exclusion Criteria
- •allergy in fentanyl or morphine
- •abnormal cognitive function patient
Arms & Interventions
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
Intervention: Fentanyl Citrate 50Mcg/Ml Inj_#1 (Drug)
Oral Morphine Syrup
Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
Pain score
Time Frame: after drug is given at 5 minutes
measure with numeric score from 0-10 point (maximum pain= 10 point)
Secondary Outcomes
- Neausea and vomiting(after drug is given at 5 minutes)
- Ithching(after drug is given at 5 minutes)
- Respiratory distress(after drug is given at 5 minutes)