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IRCT20200427047215N2 IRCT 2021-01-16 Esfahan University of Medical Sciences Pain control in bone marrow aspiration and biopsy Determining and comparing the effectiveness of intravenous injection of apotel, promethazine syrup and local anesthesia with intravenous injection of pethidine and local anesthesia in controlling pain in patients candidate for bone marrow aspiration and biopsy. 2021-01-19 anticipated 44 Complete https://irct.ir/trial/51936 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with confirmed inclusion criteria are selected through easy sampling and are placed in case or control group with random allocation software, Blinding description: In this study, patients, the main researcher, the physician and the nursing staff are kept blind to the allocation of study groups. The lidocaine injection and BMA / B process is performed by a hematologist-oncologist for all subjects. The nurse and physician who perform the injection and the procedure, as well as the patient, are unaware of the patient group. 2-3 Bone marrow disease. Intervention 1: Intervention group: 1. Infusion of one gram ampoule in 100 cc of normal saline serum half an hour before the procedure 2. 5 cc of promethazine syrup (25 mg) 30 minutes before the procedure 3. Intravenous injection of 1 cc ampoule containing normal saline fifteen minutes before the procedure 4. Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure. Intervention 2: Control group: 1. Infusion of 100 cc of normal saline serum half an hour before the procedure 2.Five cc of colored syrup without medication 30 minutes before the procedure 3. Intravenous injection of 25 mg of pethidine 15 minutes before the procedure 4. Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Ali Darakhshandeh
No 566A. 13 Alley, Saadat Ave, molana Ave, Janbazan Ave
Isfahan Iran (Islamic Republic of) 8174797677 +98 31 3777 2640 alidarakhshandeh@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ali Darakhshandeh
No 566A. 13 Alley, Saadat Ave, molana Ave, Janbazan Ave.
Isfahan Iran (Islamic Republic of) 8174797677 +98 31 3777 2640 alidarakhshandeh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18-55 years Conscious consent to enter the study BMI 18-25 18 years 55 years Both Mental retardation Generalized anxiety disorder Major Depressive Disorder Pregnancy Lactation Drug addiction Take analgesic less than 4 hours before admission Hypersensitivity to apotel, promethazine and lidocaine GFR < 30 Cirrhosis Child B & C C90 Multiple myeloma and malignant plasma cell neoplasms Treatment - Drugs Treatment - Drugs Intervention group: 1. Infusion of one gram ampoule in 100 cc of normal saline serum half an hour before the procedure 2. 5 cc of promethazine syrup (25 mg) 30 minutes before the procedure 3. Intravenous injection of 1 cc ampoule containing normal saline fifteen minutes before the procedure 4. Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure Control group: 1. Infusion of 100 cc of normal saline serum half an hour before the procedure 2.Five cc of colored syrup without medication 30 minutes before the procedure 3. Intravenous injection of 25 mg of pethidine 15 minutes before the procedure 4. Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure Reduction of pain during bone marrow biopsy and aspiration. Timepoint: Immediately after completing the procedure and 30 minutes later in the intervention and control groups. Method of measurement: To estimate the severity of pain and the effect of the drug in relieving the patient's pain from the quantitative scale VAS(Visual Analog Scale) is used. Anxiety after completing the procedure. Timepoint: After the procedure and 30 minutes later, the patient's anxiety is rated from 1 to 10, depending on the severity. Method of measurement: Anxiety severity is divided from zero to ten using a questionnaire. Esfahan University of Medical Sciences Approved 2020-12-12 Ethics committee of Isfahan University of Medical Sciences No 566,Saadat Ave, Molana Blvd, Isfahan Isfahan Isfehan Iran (Islamic Republic of)