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

Primary Purpose

Pain, Breakthrough

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Fentanyl Citrate 50Mcg/Ml Inj_#1
Morphine
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Breakthrough focused on measuring breakthrough pain, Injectable Fentanyl in Sublingual Route, gynecologic cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Injectable Fentanyl in Sublingual Route

Oral Morphine Syrup

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neausea and vomiting
measure by asking symptom from patient
Ithching
measure by asking symptom from patient
Respiratory distress
measure by respiratory rate parametor

Full Information

First Posted
May 24, 2021
Last Updated
August 30, 2022
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05037539
Brief Title
Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Breakthrough
Keywords
breakthrough pain, Injectable Fentanyl in Sublingual Route, gynecologic cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injectable Fentanyl in Sublingual Route
Arm Type
Experimental
Arm Description
Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route
Arm Title
Oral Morphine Syrup
Arm Type
Active Comparator
Arm Description
Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate 50Mcg/Ml Inj_#1
Other Intervention Name(s)
Fentanyl
Intervention Description
Injectable Fentanyl in Sublingual Route 50 mcg
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
morphine syrup
Intervention Description
Oral Morphine Syrup 2.5 ml ( 5 mg)
Primary Outcome Measure Information:
Title
Pain score
Description
measure with numeric score from 0-10 point (maximum pain= 10 point)
Time Frame
after drug is given at 5 minutes
Secondary Outcome Measure Information:
Title
Neausea and vomiting
Description
measure by asking symptom from patient
Time Frame
after drug is given at 5 minutes
Title
Ithching
Description
measure by asking symptom from patient
Time Frame
after drug is given at 5 minutes
Title
Respiratory distress
Description
measure by respiratory rate parametor
Time Frame
after drug is given at 5 minutes

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanvarat Tilagul
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15676050
Citation
Lennernas B, Hedner T, Holmberg M, Bredenberg S, Nystrom C, Lennernas H. Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: a new approach to treatment of incident pain. Br J Clin Pharmacol. 2005 Feb;59(2):249-53. doi: 10.1111/j.1365-2125.2004.02264.x.
Results Reference
background
PubMed Identifier
10353500
Citation
Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999 May;81(1-2):129-34. doi: 10.1016/s0304-3959(99)00006-8.
Results Reference
result
PubMed Identifier
18258412
Citation
Zeppetella G. Opioids for cancer breakthrough pain: a pilot study reporting patient assessment of time to meaningful pain relief. J Pain Symptom Manage. 2008 May;35(5):563-7. doi: 10.1016/j.jpainsymman.2007.06.012. Epub 2008 Feb 6.
Results Reference
result
PubMed Identifier
21215653
Citation
Mercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011 Dec;80(3):460-5. doi: 10.1016/j.critrevonc.2010.12.002. Epub 2011 Jan 6.
Results Reference
result
PubMed Identifier
23380337
Citation
Jandhyala R, Fullarton JR, Bennett MI. Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials. J Pain Symptom Manage. 2013 Oct;46(4):573-80. doi: 10.1016/j.jpainsymman.2012.09.009. Epub 2013 Feb 4.
Results Reference
result
PubMed Identifier
24385406
Citation
Velazquez Rivera I, Munoz Garrido JC, Garcia Velasco P, Espana Ximenez de Enciso I, Velazquez Clavarana L. Efficacy of sublingual fentanyl vs. oral morphine for cancer-related breakthrough pain. Adv Ther. 2014 Jan;31(1):107-17. doi: 10.1007/s12325-013-0086-4. Epub 2014 Jan 3.
Results Reference
result
PubMed Identifier
19508134
Citation
Bushnaq M, Al-Shoubaki M, Milhem M. The feasibility of using intravenous fentanyl as sublingual drops in the treatment of incidental pain in patients with cancer. J Palliat Med. 2009 Jun;12(6):511-4. doi: 10.1089/jpm.2009.9618. No abstract available.
Results Reference
result

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

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