The effect of sublingual fentanyl pill in the treatment of sudden pain in patients with cancer
- Conditions
- Breakthrough Pain in Patients with Cancer.Neoplasm related pain (acute) (chronic)G89.3
- Registration Number
- IRCT20131124015515N8
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Age 18 and above
Patients with soft, visceral and bone marrow malignancies, patients with a diagnosis of malignant tumors or malignant tumors
At least 1-4 episodes of pain per day
Receiving an opioid regimen for the control of pain at a constant and similar dose (oral morphine or opioid similar to 60-1000 mg / day / oral oxycodone 30 mg daily)
Having informed consent to participate in the study
History of receiving interatcal opioids
Patients with history of mucositis / osteomathitis Grade II and above based on the definition of the terminology of the incidence of complications
Having a condition that affects subcutaneous fentanyl tolerance or absorption of buccal mucosa
Pregnancy / Breastfeeding
Sleep apnea
Active metastasis in the brain by increasing intracranial pressure
Chronic lung obstruction
Renal or liver dysfunction
Brady's remarkable arrhythmias have not been diagnosed with heart disease
Any sudden increase in unrelated cancer pain
Conscious unwillingness to participate in the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity. Timepoint: At the onset of the episode before the start of the drug, 15, 30, 45 and 60 minutes after starting treatment. Method of measurement: The severity of pain is measured using a numeric rating scale (NRS-11) (0 = painless, mild 1-3, moderate 6-4, severe 10-7).;Episode of pain. Timepoint: Every time a breakthrogh pain occurs. Method of measurement: Recorded by patients.
- Secondary Outcome Measures
Name Time Method Side effects. Timepoint: After taking each dose of medicine. Method of measurement: Recorded by patient.