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

Phase 1

Completed

• Conditions: Pain, Breakthrough
• Interventions: Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1; Drug: Morphine

• Registration Number: NCT05037539
• Lead Sponsor: Rajavithi Hospital

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 Timeline

• Study First Submitted: 2021-05-24
• Study Start: 2021-06-15
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-08
• Primary Completion: 2021-12-30
• Study Completion: 2022-06-30
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injectable Fentanyl in Sublingual Route	Fentanyl Citrate 50Mcg/Ml Inj_#1	Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route
Oral Morphine Syrup	Morphine	Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred

Primary Outcome Measures

Name	Time	Method
Pain score	after drug is given at 5 minutes	measure with numeric score from 0-10 point (maximum pain= 10 point)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand