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IRCT20191201045563N1 IRCT 2020-01-05 Semnan University of Medical Sciences The efficacy of intravenous Labetalol on pain controlling and anxiety during bone marrow aspiration and biopsy Comparison of the efficacy of intravenous Labetalol and the usual method (local anesthesia) on pain controlling and anxiety during bone marrow aspiration and biopsy 2019-12-06 anticipated 40 Complete https://irct.ir/trial/43914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A simple random method using random numbers table; with the help of someone other than the researcher, the sealed packets are prepared, on which the numbers are placed behind each other, in which the intervention or control group is determined according to the random number table. َAnd the numbers are used for patients in the study, respectively.Thus, each patient is accidentally in the intervention or control group, Blinding description: Study participants, principal investigator and Statistical analyzer;The drug used in the control and intervention groups is administered by a person other than the principal investigator, the clinical caregiver. the results of the data are presented in the form of groups called 1 and 2 to statistical classifiers.Although patients are given the necessary knowledge of the study and informed consent is obtained, they will not be informed about the group in which they are participating. 2 Bone Marrow Aspiration and Biopsy. Intervention 1: Intervention group: Patients in the intervention group will receive IV labetalol (5mg) in addition to fentanyl and anesthesia. Intervention 2: Control group: Patients in the control group will receive local anesthesia, fentanyl and placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Masoudeh Darzi
Kosar hospital, Amin blvd, Golestan town
semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 MasoudehDarzi@semums.ac.ir Semnan University of Medical Sciences scientific Masoudeh Darzi
Kosar hospital, Amin blvd, Golestan town
semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 MasoudehDarzi@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years old Definitive indication of bone marrow aspiration and biopsy 18 years no limit Both Unwillingness to participate in the study Cardiovascular disease (Heart block, Arrhythmia) Uncontrolled chronic obstructive pulmonary disease Uncontrolled Asthma Unstable hemodynamics especially hypotension, bradycardia Consciousness disorder Pregnancy and lactation Bad physical conditions Using analgesic agents for the past 24 hours Elderly people with advanced systemic disease Vertigo, headache, dyspnea, nausea before the procedure Treatment - Drugs Placebo Intervention group: Patients in the intervention group will receive IV labetalol (5mg) in addition to fentanyl and anesthesia. Control group: Patients in the control group will receive local anesthesia, fentanyl and placebo. Pain intensity based on 10cm visual analogue scale(VAS). Timepoint: During the procedure, 5 minutes and one hour after the procedure. Method of measurement: 10cm visual analogue scale (VAS). Anxiety score. Timepoint: 30 minutes before starting the procedure and during the procedure. Method of measurement: Clinical Anxiety-Depression Self-Assessment Scale (HADS). Amount of opioids used during the procedure and within 24 hours after the procedure. Timepoint: During the procedure, up to 24 hours after the procedure. Method of measurement: Record the amount of drug used in each patient. Semnan University of Medical Sciences Approved 2019-11-23 Ethics committee of Semnan University of Medical Sciences Headquarters building of Semnan University of Medical Sciences, Basij blvd., Moallem Square Semnan Semnan Iran (Islamic Republic of)