Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Pain, Breakthrough

Intervention / Treatment
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* Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injectable Fentanyl in Sublingual Route<br>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<br>* Injectable Fentanyl in Sublingual Route 50 mcg<br>* Other names: Fentanyl;|
| Active Comparator: Oral Morphine Syrup<br>Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred | Drug: Morphine<br>* Oral Morphine Syrup 2.5 ml ( 5 mg)<br>* Other names: morphine syrup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | after drug is given at 5 minutes | 
| Respiratory distress | measure by respiratory rate parametor | after drug is given at 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breakthrough pain, Injectable Fentanyl in Sublingual Route, gynecologic cancer