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IRCT20170809035601N9 IRCT 2018-10-23 Esfahan University of Medical Sciences Effect of propofol-ketamine and propofol-sufentanil on sedation and analgesia in painful diagnostic methods in children with hematological malignancies Comparative evaluation of the effect of the two combinations of Propofol-Ketamine and Propofol-Sufentanil on sedation and analgesia during painful diagnostic procedures in children with hematologic malignancies 2017-03-21 anticipated 120 Complete https://irct.ir/trial/33488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in the operating room are divided into two groups by random allocation software (Random allocation software). The first group propofol, ketamine, and the second group will receive propofol, sufentanil, Blinding description: In the present study, participants, the main investigator and the person collecting data are unaware of the grouping of patients and the type of medication. 2 Acute lymphoblastic leukaemia [ALL]. Intervention 1: In the PK group, propofol 1mg / kg with 5mg / cc of vectamine (0 / 3mg / kg) with 5mg / cc concentration of drug was added to 20 cc and the infusion of the drug continued to reach the appropriate sedation level. Intervention 2: Control group: In the PS group, sufentanil 0.5mic / kg and propofol 1mg / kg at a concentration of 5mg / cc, the volume of the drug was added to 20 cc.  Infusion of the drug compound continues to flush with the appropriate sedation level:. Yes - There is a plan to make this available What will be shared: The data include the amount of sedation and pain level and hemodynamic indicators and complications in both groups after the intervention of unrecognizable people sharing. When: Beginning 6 months after the publication access To whom: Academic and health researchers Conditions: Used for research and therapeutic Where to obtain: Email responsible for public accountability study: ​hamidshetabi@med.mui.ac.ir How to obtain: If access upon request via e-mail will be sent within a maximum 1 month Comments:
public Hamidreza shetabi
Alzahra Hospital, Sofe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Al-Zahra Medical Center, Department of Anesthesia, Sofe Bolvd
Isfahan Iran (Islamic Republic of) 8174173461 +98 31 3668 5555 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children aged 1 to 14 years Hematologic malignancies Acute lymphoblastic leukemia 1 year 14 years Both A recent trauma to the head Cardiovascular, pulmonary, or liver diseases Epilepsy, seizure or neurological disorder Use of analgesic or sedative medications before surgery Chronic pain syndrome History of allergy to the drugs studied C91.0 Acute lymphoblastic leukemia [ALL] Treatment - Drugs Treatment - Drugs In the PK group, propofol 1mg / kg with 5mg / cc of vectamine (0 / 3mg / kg) with 5mg / cc concentration of drug was added to 20 cc and the infusion of the drug continued to reach the appropriate sedation level. Control group: In the PS group, sufentanil 0.5mic / kg and propofol 1mg / kg at a concentration of 5mg / cc, the volume of the drug was added to 20 cc.  Infusion of the drug compound continues to flush with the appropriate sedation level: Sedation level. Timepoint: During procedure. Method of measurement: university of michigan sedation scale. Analgesia. Timepoint: During procedure. Method of measurement: Universal Pain Assessment Tool. Esfahan University of Medical Sciences Approved 2017-05-22 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar jerib Blvd Isfahan Isfehan Iran (Islamic Republic of)