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IRCT20160430027677N23 IRCT 2022-10-05 Oroumia University of Medical Sciences The effect of pregabalin on postoperative pain in craniotomy Evaluation of the pregabalin effect on postoperative pain in elective craniotomy 2022-10-23 anticipated 50 Complete https://irct.ir/trial/66013 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into two groups pregabaline 300 mg (group P) and placebo (C) using Random Allocation Software 2.0, and the target codes will be written on a piece of paper and placed in sealed envelopes with sequential allocation, Blinding description: The drug will be administered by the nurse in the ward and at the time of admission, the anesthesiologist will be unaware which patient will be assigned to which group. Drug containers will be identical and only the nurse will know about the contents of each of them, and finally, after collecting information by the resident in training in anesthesiology, the anesthesiology specialist will be informed of the group each patient is assigned to. 2-3 Post craniotomy pain. Intervention 1: Intervention group: patients will receive Pregabalin 300 Mg oral tablet, 90 minutes before surgery. Intervention 2: Control group: patients will receive placebo oral tablet, 90 minutes before surgery. 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 No more information
public Shahryar Sane
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences scientific Shahryar Sane
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Being at the age of 20 to 60 years old American Society of Anesthesiologists class I and II Being candidate for elective craniotomy 20 years 60 years Both History of congenital mental retardation or mental disorders Pregnancy or breastfeeding History of systemic malignant tumor Previous treatment using this protocol or participation in another experimental study within the last 30 days Allergy to the drugs used in the study Body mass index greater than 30 Drug or alcohol addiction R52.0 Acute pain Prevention Placebo Intervention group: patients will receive Pregabalin 300 Mg oral tablet, 90 minutes before surgery. Control group: patients will receive placebo oral tablet, 90 minutes before surgery. Pain. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Mean Arterial Blood Pressure. Timepoint: In recovery, during Laryngoscopy, 6, 12 and 24 hours after surgery. Method of measurement: None Invasive Blood Pressure. Mean pulse Rate. Timepoint: In recovery, during Laryngoscopy, 6, 12 and 24 hours after surgery. Method of measurement: Electrocardiogram. Oroumia University of Medical Sciences Approved 2022-08-30 Ethics commitee of Urmia University of Medical Sciences Orjanse alley, Resalat blvd Urmia West Azarbaijan Iran (Islamic Republic of)