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NCT Number: NCT05037539

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

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

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Key information

Conditions

Pain, Breakthrough Breakthrough Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rajavithi Hospital

Bangkok, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Citrate 50Mcg/Ml Inj_#1

Drug

Injectable Fentanyl in Sublingual Route 50 mcg

Other names: Fentanyl

Morphine

Drug

Oral Morphine Syrup 2.5 ml ( 5 mg)

Other names: morphine syrup

Primary outcomes

  1. Pain score

    Time frame: after drug is given at 5 minutes

    measure with numeric score from 0-10 point (maximum pain= 10 point)

Secondary outcomes

  1. Neausea and vomiting

    Time frame: after drug is given at 5 minutes

    measure by asking symptom from patient

  2. Ithching

    Time frame: after drug is given at 5 minutes

    measure by asking symptom from patient

  3. Respiratory distress

    Time frame: after drug is given at 5 minutes

    measure by respiratory rate parametor

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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