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IRCT20191104045328N9 IRCT 2022-03-03 Arak University of Medical Sciences Comparison of the effect of dexmedetomidine and midazolam on the prevention of agitation before aspiration and bone marrow biopsy : A Comparative Study of the Effect of Dexmedmotidine and Midazolam on Prevention of Agitation Before Bone Marrow Aspiration and Bone Marrow Biopsy and Intracranial Chemo Therapy in Cancerous Children 2022-04-05 anticipated 90 Complete https://irct.ir/trial/62260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in, Blinding description: Vials of the same volume are drawn into the same syringes, and the patient's participant and clinical caregiver (nurse) are unaware of its contents. 3 Agitation before aspiration and bone marrow biopsy. Intervention 1: Intervention group: 45 children 2 to 15 years of age who receive a 5-minute intravenous infusion of 2 micrograms per kilogram of dexmedetomidine intravenously before performing a biopsy procedure and bone marrow aspiration or intrathecal chemotherapy. Intervention 2: Intervention group: Forty-five children will receive a 5-minute intravenous midazolam injection at a dose of 0.2 mg / kg before a biopsy procedure and bone marrow aspiration or intrathecal chemotherapy. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2022/4/20 to 2026/4/20 for 4 years. To whom: University researchers Conditions: If there are any further questions Where to obtain: Dr. Vahid Falahati How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Vahid Falahati
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 vahidfalahati@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Aziz Eghbali
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 38 1969 3345 dr.eghbali@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) All children 2 to 15 years old who are candidates for bone marrow biopsy and aspiration or intrathecal chemotherapy. Obtaining informed consent from the patient (parents) 2 years 15 years Both Contraindication of lumbar puncture History of cardiopulmonary and renal disease Existence of anatomical disorders in the patient's neck and spine R45.1 Restlessness and agitation Treatment - Drugs Treatment - Drugs Intervention group: 45 children 2 to 15 years of age who receive a 5-minute intravenous infusion of 2 micrograms per kilogram of dexmedetomidine intravenously before performing a biopsy procedure and bone marrow aspiration or intrathecal chemotherapy. Intervention group: Forty-five children will receive a 5-minute intravenous midazolam injection at a dose of 0.2 mg / kg before a biopsy procedure and bone marrow aspiration or intrathecal chemotherapy. 4-point sedation scale. Timepoint: 4-point sedation scale measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: 4-point sedation scale include: Restlessness: 4 Awakening: 3 Sleepy: 2 Sleeping: 1. (Which are desirable in this scale of 1st and 2nd degree.) This scale is measured based on the judgment of the doctor in the examination. Respiratory rate per minute. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting. Blood pressure. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Barometer cuff. Oxygen saturation. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Pulse oximetry. Heart rate per minute. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting. Arak University of Medical Sciences Approved 2021-07-18 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)