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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05037539
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
11.5
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official 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
Actual Study Start Date :
Jun 15, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Injectable Fentanyl in Sublingual Route

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

Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1
Injectable Fentanyl in Sublingual Route 50 mcg
Other Names:
  • Fentanyl

    		•
    Active Comparator: Oral Morphine Syrup

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

    Drug: Morphine
    Oral Morphine Syrup 2.5 ml ( 5 mg)
    Other Names:
  • morphine syrup

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain score [after drug is given at 5 minutes]

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

    Secondary Outcome Measures

    1. Neausea and vomiting [after drug is given at 5 minutes]

      measure by asking symptom from patient

    2. Ithching [after drug is given at 5 minutes]

      measure by asking symptom from patient

    3. Respiratory distress [after drug is given at 5 minutes]

      measure by respiratory rate parametor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rajavithi Hospital Bangkok Thailand

    Sponsors and Collaborators

    • Rajavithi Hospital

    Investigators

    • Study Director: Thanvarat Tilagul, Rajavithi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rajavithi Hospital
    ClinicalTrials.gov Identifier:
    NCT05037539
    Other Study ID Numbers:
    • 090/2564
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Rajavithi Hospital
    breakthrough pain
    Injectable Fentanyl in Sublingual Route
    gynecologic cancer
    Additional relevant MeSH terms:
    Breakthrough Pain
    Fentanyl
    Morphine

    Study Results

    No Results Posted as of Sep 8, 2021