A Comparative Study of The Efficacy of Ketamine and Intravenous Dexmedetomidine in Preventing Agitation in Children with Cancer Before Biopsy and Bone Marrow Aspiration

Comparison of The Efficacy of Ketamine and Intravenous Dexmedetomidine in Preventing Agitation in Children with Cancer Before Biopsy and Bone Marrow Aspiration

Clinical trial on two parallel intervention groups Bilaterally blind with block randomization method Phase 3 on 72 patients

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 Ketamine 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

Children eligible for the study are randomly divided into 2 intervention groups who receive 1-ketamine and 2-dexmedetomidine before biopsy and bone marrow aspiration.

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 the publication of the article, confidential information such as patient and hospital details, etc. will be deleted and other information will be provided to researchers.

After publishing the article

Medical specialists

Medical professionals can access the data for research purposes.

Email the corresponding author

Official and academic email to the corresponding author