Clinical trial · Interventional
Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain
The Analgesic Efficacy of Oral Piroxicam Versus Buccal Fentanyl in Cancer Breakthrough Pain in Patients With Bone Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral perixicam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- oral perixicam
- description
- 50 patients with Breakthrough pain will receive oral prioxicam for treament of breakthrough pain.
- interventionNames
- Drug: oral perixicam
- type
- NO_INTERVENTION
- label
- oral fentanyl
- description
- 50 patients with Breakthrough pain will receive sublingual fentanyl for treament of breakthrough pain.
Primary outcomes (1)
- measure
- analgesic scale (assessmet of VAS immeditally after analgesic adminstration)
- timeFrame
- two hours
- description
- assessmet of VAS immeditally after analgesic adminstration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available