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IRCT20171211037834N1 IRCT 2018-02-17 Esfahan University of Medical Sciences The analgesic effect of Nebulized Morphine, Fentanyl Transdermal Patch and Oral Methadone The comparison of analgesic effects of nebulized morphine with fentanyl transdermal patch and oral methadone for cancer patients in terminal stages 2017-04-21 anticipated 90 Complete https://irct.ir/trial/28252 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple personal randomization by random allocation software, Blinding description: First of all for each patient a code was allocated. Codes allocations explain as follow: 101 to 130: allocated to Morphine nebulized (group 1) 201 to 230: allocated to Fentanyl trans-dermal patch (group 2) 301 to 330: allocated to oral Methadone (group 3) A person as assessor was going to patient's bedside and asked about his/her pain severity (with Visual Analog Scale). The questioner kept unaware about the kind of medicines and the group of each patients (nebulized Morphine, Fentanyl trams-dermal patch, oral Methadone) and also about the codes classification. He was just adding the codes in the form. Analyzer also did not know about classifications of codes and just was dividing the patient in groups according codes. 3 Condition 1: Breast cancer. Condition 2: Lung cancer. Condition 3: Prostate cancer. Condition 4: Liver cancer. Condition 5: Colon cancer. Condition 6: Stomach cancer. Condition 7: Uterus cancer. Condition 8: Bladder cancer. Intervention 1: Intervention group: nebulized group, received nebulization of 20-mg Morphine, repeated every 10minutes with a maximum of 3 nebulizations. Intervention 2: Intervention group: Fentanyl group, received 0.6 mg of transdermal Fentanyl. The transdermal patch was changed every 72 hr. Intervention 3: Control group: oral Methadone group, were treated with oral Methadone (maximum dose of 45 mg/day) divided in three doses. Yes - There is a plan to make this available What will be shared: All of data, after unrecognizable process are accessible. When: access is possible 1 year after publish. To whom: Access is possible just for academic research centers. Conditions: Data Analysis is allowed and there is not any specific limitation. Where to obtain: Requests should be send to electronic mail and attach documented mail from associated research center How to obtain: After request receiving, inquiry mail will be send for associated research center. After confirmation, data will be send for applicant Comments:
public Mahdi Ebrahini
No. 41, Ashrafi Isfahan Blvd.
Isfahan Iran (Islamic Republic of) 0000000000 +98 31 3771 8986 m.ebrahimi@resident.mui.ac.ir Esfahan University of Medical Sciences scientific Mahdi Ebrahimi
Alzahra hodpital, Shohadaye sofe ave
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3771 8986 m.ebrahimi@resident.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Suffering from moderate or severe pain Patient awareness about his/her situation and illness Suitable Glasgow Coma Scale (GCS) for patient cooperation 18 years no limit Both Allergy to Opioids Hypotension(Systolic Blood pressure lower than 110 mmHg) Bradypnea (respiration rate less than 12 times per minutes) Hypoxemia (Oxygen saturation lower than 90 percent in room temperature) Rhinitis Liver and kidney disorders Hypothyroidism Prostate hypertrophy Addison's disease C50 C34 C61 C22.0 C18 C16 C55 C67 Malignant neoplasm of breast Malignant neoplasm of bronchus and lung Malignant neoplasm of prostate Liver cell carcinoma Malignant neoplasm of colon Malignant neoplasm of stomach Malignant neoplasm of uterus, part unspecified Malignant neoplasm of bladder Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: nebulized group, received nebulization of 20-mg Morphine, repeated every 10minutes with a maximum of 3 nebulizations. Intervention group: Fentanyl group, received 0.6 mg of transdermal Fentanyl. The transdermal patch was changed every 72 hr. Control group: oral Methadone group, were treated with oral Methadone (maximum dose of 45 mg/day) divided in three doses. Pain. Timepoint: At the beginning of the study (before the intervention) and at the beginning and end of each day for 3 days. Method of measurement: Visual Analog Score that is numbered from 0 to 10. Esfahan University of Medical Sciences Approved 2017-05-03 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran Isfahan Isfehan Iran (Islamic Republic of)