NCT05037539

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Pain, Breakthrough

Interventions

Type	Name	Description
DRUG	Fentanyl Citrate 50Mcg/Ml Inj_#1	Injectable Fentanyl in Sublingual Route 50 mcg
DRUG	Morphine	Oral Morphine Syrup 2.5 ml ( 5 mg)

Timeline

• Start date: 2021-06-15
• Primary completion: 2021-12-30
• Completion: 2022-06-30
• First posted: 2021-09-08
• Last updated: 2022-08-31

Locations

1 site across 1 country: Thailand