Pain, Breakthrough
Conditions
Keywords
breakthrough pain, Injectable Fentanyl in Sublingual Route, gynecologic cancer
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
Interventions
DRUGFentanyl Citrate 50Mcg/Ml Inj_#1
Injectable Fentanyl in Sublingual Route 50 mcg
DRUGMorphine
Oral Morphine Syrup 2.5 ml ( 5 mg)
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | after drug is given at 5 minutes | measure with numeric score from 0-10 point (maximum pain= 10 point) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neausea and vomiting | after drug is given at 5 minutes | measure by asking symptom from patient |
| Ithching | after drug is given at 5 minutes | measure by asking symptom from patient |
| Respiratory distress | after drug is given at 5 minutes | measure by respiratory rate parametor |
Countries
Thailand
Outcome results
None listed