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IRCT20211121053130N1 IRCT 2021-12-11 Fasa University of Medical Sciences effect of magnesium sulfate on pain and agitation after tonsillectomy study and compare two different doses of magnesium sulfate in decreasing pain and agitation of children after tonsillectomy 2021-12-11 anticipated 120 Complete https://irct.ir/trial/60143 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After generating random block sequences by Random Allocation Software version 1.0.0, the sequences in each block will be placed in numbered envelopes. for each group of patients, we randomly select one of the blocks, the sequences in each block will be used to assign individuals to one of the study groups, Blinding description: preparation of medication and placebo will be performed and labeld as A,B,C by researchers and will be given to OR personel who has no idea about labels meaning. researchers have no role in giving the medication and measuring the outcome. As above,Statistical analyzer will analyze the data without the knowledge that each group receive which medication. 3 pain and agitation after tonsillectomy in children. Intervention 1: Control group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.first group as control group will receive no further medication but placebo with same administration method of magnesium sulfate. Intervention 2: first Intervention group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.then the will receive 30 mg/kg mg sulfate as loading dose fallowed by 10mg/kg/hr for 1 hour as maintenance dose. Intervention 3: second Intervention group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.then the will receive 40 mg/kg mg sulfate as loading dose fallowed by 10mg/kg/hr for 1 hour as maintenance dose. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision on releasing the data will be made based on supervisor professrors in future
public Mohammad Reza Malek Motiei
Ebne Sina Square
Fasa Iran (Islamic Republic of) ۸۶۶۸۸ - ۷۴۶۱۶ +98 71 5335 0994 Info@fums.ac.ir Fasa University of Medical Sciences scientific Sedighe Ahmadi
Ebne Sina Square
Fasa Iran (Islamic Republic of) ۸۶۶۸۸ - ۷۴۶۱۶ +98 71 5335 0994 Ahmadis@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) consent of patient and parentsASA class I II II need to do tonsillectomy ASA class I II II 3 years 15 years Both Unwillingness to participate in study ASA class IV anatomical abnormalities in airway reoperation due to bleeding difficult intubation History of cardiology,renal,respiratory diseases History of MG J35.1 Hypertrophy of tonsils Placebo Treatment - Drugs Treatment - Drugs Control group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.first group as control group will receive no further medication but placebo with same administration method of magnesium sulfate. first Intervention group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.then the will receive 30 mg/kg mg sulfate as loading dose fallowed by 10mg/kg/hr for 1 hour as maintenance dose second Intervention group: anesthesia induction will be done by administration of midazolam 0.5-1 mg/kg , Atra 0.4-0.6 mg/kg , STP 5-7 mg/kg and fentanyl 2mcg/kg by anesthesiologist.then the will receive 40 mg/kg mg sulfate as loading dose fallowed by 10mg/kg/hr for 1 hour as maintenance dose Pain. Timepoint: 5 minutes after extubation/10 minutes after extubation/15 minutes after extubation/30 minutes after extubation/1hour after extubation/2 hour after extubation/6 hour after extubation/. Method of measurement: FLACC score for pain. Agitation. Timepoint: 5 minutes after extubation/10 minutes after extubation/15 minutes after extubation/30 minutes after extubation/1hour after extubation/2 hour after extubation/6 hour after extubation/. Method of measurement: Ricker-sedation-agitation score. Fasa University of Medical Sciences Approved 2021-11-21 Ethics committee of fasa University of Medical Sciences ebne sina square fasa fars fasa Fars Iran (Islamic Republic of)