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
About this trial
This is an interventional supportive care trial for Neoplasm Metastases
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.
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
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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