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

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Breakthrough
• Intervention / Treatment: Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1; Drug: Morphine

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	measure with numeric score from 0-10 point (maximum pain= 10 point)	after drug is given at 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neausea and vomiting	measure by asking symptom from patient	after drug is given at 5 minutes
Ithching	measure by asking symptom from patient	after drug is given at 5 minutes
Respiratory distress	measure by respiratory rate parametor	after drug is given at 5 minutes

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Study Director: Thanvarat Tilagul, Rajavithi Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: breakthrough pain; Injectable Fentanyl in Sublingual Route; gynecologic cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: 090/2564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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