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IRCT20131124015515N8 IRCT 2019-08-02 Shahid Beheshti University of Medical Sciences The effect of sublingual fentanyl pill in the treatment of sudden pain in patients with cancer Efficacy and safety of Fentanyl Sublingual for treatment of Breakthrough Pain in Patients with Cancer 2019-07-22 anticipated 100 Complete https://irct.ir/trial/40879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization based on random numbers table, Blinding description: Participant and clinical outcomes evaluator are not aware of the code assigned to each of the groups. 2-3 Breakthrough Pain in Patients with Cancer. Intervention 1: Intervention group: Fentanyl Sublingual tablet: In our study, the available doses of 100 and 200 μg subcutaneous fentanyl: Faran Chemical Co., Iran. Patients are required to record the baseline pain score after the start of a sudden pain attack, then start fentanyl sublingual 100 micrograms. Patients can use other opioids that are used in the study, if they do not improve the patient's pain satisfactorily within 30 minutes after the initial dosage is dissolved. Usually, breakthrough pain onset of subsequent pain occurs at least 4 hours after receiving fentanyl sublingual or other opioids used in the study. If a dose of 100 μg did not improve the patient's satisfactory pain and the side effects of the medication could be tolerated, a sudden attack of the next pain could be done using 200 μg fentanyl Sublingual . Intervention 2: Control group: Placebo tablet: Similar to fentanyl Sublingual of 100 and 200 micrograms: Faran Chemical Company-Country: Iran. The control group used sublingual fentanyl from placebo and the oral opioid diet of 60-1000 mg / day / oral ocicidone 30 mg daily for relief of pain. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: En Start the access period 12 months after printing the results To whom: Only available to scholars working in academic and academic institutions Conditions: Employed in research centers Where to obtain: Person responsible for scientific inquiries How to obtain: Send email to person responsible for scientific inquiries Comments:
public Masoud Hashemi MD.
Akhtar Hospital, Sharifi Manesh st.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Masoud Hashemi MD.
Akhtar Hospital, Sharifi Manesh st.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 G89.3 Neoplasm related pain (acute) (chronic) Treatment - Drugs Placebo Intervention group: Fentanyl Sublingual tablet: In our study, the available doses of 100 and 200 μg subcutaneous fentanyl: Faran Chemical Co., Iran. Patients are required to record the baseline pain score after the start of a sudden pain attack, then start fentanyl sublingual 100 micrograms. Patients can use other opioids that are used in the study, if they do not improve the patient's pain satisfactorily within 30 minutes after the initial dosage is dissolved. Usually, breakthrough pain onset of subsequent pain occurs at least 4 hours after receiving fentanyl sublingual or other opioids used in the study. If a dose of 100 μg did not improve the patient's satisfactory pain and the side effects of the medication could be tolerated, a sudden attack of the next pain could be done using 200 μg fentanyl Sublingual . Control group: Placebo tablet: Similar to fentanyl Sublingual of 100 and 200 micrograms: Faran Chemical Company-Country: Iran. The control group used sublingual fentanyl from placebo and the oral opioid diet of 60-1000 mg / day / oral ocicidone 30 mg daily for relief of pain. 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. Side effects. Timepoint: After taking each dose of medicine. Method of measurement: Recorded by patient. Shahid Beheshti University of Medical Sciences Approved 2019-06-29 Ethics committee of Cancer Research Center of Shahid Beheshti University of Medical Sciences Tajrish square, Shohada Tajrish Hospital Tehran Tehran Iran (Islamic Republic of)