: 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

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

This study is a double-blind randomized trial that is the study phase 3 and block randomization method is used for randomization.

This study was a double-blind randomized clinical trial with parallel groups in which children aged 2 to 15 years who were candidates for bone marrow biopsy and aspiration procedures were divided into two identical groups: dexmedetomidine and midazolam and They are then compared for agitation and vital signs.

Inclusion criteria: 1- All children 2 to 15 years old who are candidates for biopsy and bone marrow aspiration or intrathecal chemotherapy. 2- Obtaining informed consent from the patient (parents) Conditions of non-entry: 1- Existence of contraindication of lumbar puncture 2- History of cardiopulmonary and renal disease 3- Existence of anatomical disorders in the patient's neck and spine

Dexmedetomidine group: 45 children 2 to 15 years old who will receive a 5-minute intravenous infusion of dexmedetomidine at a dose of 2 micrograms per kilogram. Midazolam group: 45 children receiving a 5-minute intravenous midazolam injection at a dose of 0.2 mg / kg.

4-point sedation scale measured at 5, 10, 20, 30 minutes after drug injection. Respiratory rate per minute, measured at 5, 10, 20, 30 minutes after drug injection. Blood pressure is measured at 5, 10, 20, 30 minutes after drug injection. Oxygen saturation is measured at 5, 10, 20, 30 minutes after drug injection. Heart rate per minute measured at 5, 10, 20, 30 minutes after drug injection. .

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.

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.

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.

Access will be from 2022/4/20 to 2026/4/20 for 4 years.

University researchers

If there are any further questions

Dr. Vahid Falahati

Letter writing should be done with professors and universities.