Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain
Condition: Neoplasm Metastases
MeSH terms: Neoplasm Metastasis; Breakthrough Pain
Study type: Interventional

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.
    

Intervention name(s): oral perixicam
Intervention type(s): Drug
Intervention description(s): Oral adminstration of buccal perixicam
Other intervention name(s): feldene flash
Intervention MeSH terms: Piroxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care