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Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain

Primary Purpose

Neoplasm Metastases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral perixicam
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasm Metastases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible participants were all:

  • adults aged 18 or over
  • suffering from Background pain cancer pain
  • whose cancer pain was treated with strong opioids and
  • who had breakthrough pain which met the criteria described by Portenoy.

Exclusion Criteria:

Exclusion criteria were:

  • less than18 years old,
  • non-controlled basal pain,
  • hospitalized patients, or cognitive disturbances,
  • patients with contraindication to NSAIDS such as:

    • gastric ulcer,
    • impaired renal function,
    • cerebrovascular accident,
    • coronary artery bypass graft,
    • uncontrolled hypertension,
    • patients with coagulation anomalies such as hepatic disease or
    • patients a previous history of allergy to NSAID.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    oral perixicam

    oral fentanyl

    Arm Description

    50 patients with Breakthrough pain will receive oral prioxicam for treament of breakthrough pain.

    50 patients with Breakthrough pain will receive sublingual fentanyl for treament of breakthrough pain.

    Outcomes

    Primary Outcome Measures

    analgesic scale (assessmet of VAS immeditally after analgesic adminstration)
    assessmet of VAS immeditally after analgesic adminstration

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2015
    Last Updated
    May 11, 2016
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02382653
    Brief Title
    Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain
    Official Title
    The Analgesic Efficacy of Oral Piroxicam Versus Buccal Fentanyl in Cancer Breakthrough Pain in Patients With Bone Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP) (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two equal groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group, comprising of 50 patients each. Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain). frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or over 16 min), time required for dose titration, patient satisfaction and adverse effects were assessed at 3, 7, 15, and 30 days after starting the treatment.
    Detailed Description
    In this prospective, longitudinal, controlled-study, 100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP) (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two equal groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group, comprising of 30 patients each. Eligible participants were all adults aged 18 or over suffering from Background pain cancer pain whose cancer pain was treated with strong opioids and who had breakthrough pain which met the criteria described by Portenoy.(5) (stable analgesia in the previous 48 h, controlled background pain in the previous 24 h, transient exacerbation of pain in the previous 24 h). The term strong opioid refers to medicines classified as being on step three of the World Health Organization (WHO) analgesic ladder. In Egypt the strong opioids available include fentanyl, morphine and hydromorphone. Exclusion criteria were less than18 years old, non-controlled basal pain, hospitalized patients, or cognitive disturbances, patients with contraindication to NSAIDS such as gastric ulcer, impaired renal function, cerebrovascular accident, Coronary artery bypass graft , Uncontrolled hypertension, patients with coagulation anomalies such as hepatic disease or patients a previous history of allergy to NSAID. Randomization will be performed by random numbers using sealed envelopes without sex stratification. Sealed envelopes indicate the group of assignment. An independent anesthesiologist, who did not participate in the study or data collection, will read the number contained in the envelope and made group assignments. Patients will be blindly randomized to the two groups; the process of inclusion into the study will go on until the requested number of patients will be reached. Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain). frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or over 16 min), time required for dose titration, patient satisfaction and adverse effects were assessed at 3, 7, 15, and 30 days after starting the treatment. The primary outcome is the degree of breakthrough pain score using VAS in the two groups. The secondary outcomes measures are analgesic requirement, patients satisfaction, and identification of undesirable effects that may be associated with the use of both drugs in patients with breakthrough pain in both groups. All adverse events related to surgery and the regional anesthetic technique will be recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasm Metastases

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oral perixicam
    Arm Type
    Other
    Arm Description
    50 patients with Breakthrough pain will receive oral prioxicam for treament of breakthrough pain.
    Arm Title
    oral fentanyl
    Arm Type
    No Intervention
    Arm Description
    50 patients with Breakthrough pain will receive sublingual fentanyl for treament of breakthrough pain.
    Intervention Type
    Drug
    Intervention Name(s)
    oral perixicam
    Other Intervention Name(s)
    feldene flash
    Intervention Description
    Oral adminstration of buccal perixicam
    Primary Outcome Measure Information:
    Title
    analgesic scale (assessmet of VAS immeditally after analgesic adminstration)
    Description
    assessmet of VAS immeditally after analgesic adminstration
    Time Frame
    two hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eligible participants were all: adults aged 18 or over suffering from Background pain cancer pain whose cancer pain was treated with strong opioids and who had breakthrough pain which met the criteria described by Portenoy. Exclusion Criteria: Exclusion criteria were: less than18 years old, non-controlled basal pain, hospitalized patients, or cognitive disturbances, patients with contraindication to NSAIDS such as: gastric ulcer, impaired renal function, cerebrovascular accident, coronary artery bypass graft, uncontrolled hypertension, patients with coagulation anomalies such as hepatic disease or patients a previous history of allergy to NSAID.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayman A Yousef
    Organizational Affiliation
    Assistant professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain

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