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

Rajavithi Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pain, Breakthrough

Treatments: Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT05037539

090/2564

Details and patient eligibility

About

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

Full 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

Enrollment: 20 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Injectable Fentanyl in Sublingual Route

Experimental group

Description:

Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route

Treatment:

Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1

Oral Morphine Syrup

Active Comparator group

Description:

Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred

Treatment:

Drug: Morphine