Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain

NCT ID: NCT02382653

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Neoplasm Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

oral perixicam

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

Group Type: OTHER

oral perixicam

Intervention Type: DRUG

Oral adminstration of buccal perixicam

oral fentanyl

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

oral perixicam

Oral adminstration of buccal perixicam

Intervention Type: DRUG

Other Intervention Names

feldene flash

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Abd Al-maksoud Yousef

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman A Yousef

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Other Identifiers

2970/12/14

Identifier Type: -

Identifier Source: org_study_id