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IRCT20210904052371N1 IRCT 2021-10-19 Mazandaran University of Medical Sciences Compare the effect of clonidine and tizanidine in controlling pain after lumbar fusion surgery Compare the effect of clonidine and tizanidine in controlling pain after lumbar fusion surgery 2019-07-16 anticipated 75 Complete https://irct.ir/trial/58502 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients who met the inclusion criteria were determined using a computer program of random numbers by the method (Block permutated randomization) and also to hide the process of randomization Concealment after randomization of patients, drugs are placed in envelopes with specified numbers. These envelopes were given to patients at the time of administration by the anesthesia nurse in a recovery that did not know the contents of the envelopes. As a result, patients were randomly divided into three groups of 25 people A, B and C. Adequate explanations and training will be provided on how to determine the severity of pain, nausea, vomiting and itching after surgery using the VAS (Visual Analog Scale) criterion and how to use the PCA pump. According to the patients in the three groups, patients in group A received one 4 mg tizanidine tablet (manufactured by Galenus) orally and patients in group B received a 4.4 mg tablet. Gram clonidine (manufactured by Galenus) will be taken orally one hour before the operation and 24 hours later they will take one of these pills and patients in group C will be given one tablet in the same place as the placebo, Blinding description: This study is double-blind and neither the patient nor the nurse of the project knows the type of intervention. Concealment randomization process After randomization of patients, the drugs were placed in envelopes with specific numbers, which were given to the patients when they were prescribed by the anesthesia nurse in the recovery, who did not know the contents of the envelopes. 3 Pain control after cesarean section. Intervention 1: Intervention group: Clonidine. Intervention 2: Intervention group: tizanidine. Intervention 3: Control group: Plasbo. 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 There is no more information
public Goli Azzi
Amir Mazandarani St. Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Goli Aezi
Amir Mazandarani St., Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Confirm the diagnosis by physical examination, CT scan and MRI The patient's desire to participate in the study and gain informed consent Candidate for non-emergency lumbar fusion surgery Age between 70-35 years and No history of tizanidine allergy Absence of bradycardia (HR <60) in patients Absence of CNS disease No history of any previous back surgery 35 years 70 years Both The patient's unwillingness to continue participating in the study at any time Taking narcotic painkillers 24 hours before the intervention Alcohol or drug abuse Occurrence of any unusual complication during surgery G89.18 Other acute postprocedural pain Rehabilitation Rehabilitation N/A Intervention group: Clonidine Intervention group: tizanidine Control group: Plasbo Intensity of patients' pain. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. The amount of drugs used. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. The rate of nausea. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. The rate of vomiting. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. Itching rate. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. Dry mouth. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. Bradycardia rate. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. Headache rate. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. Vertigo. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. The rate of drowsiness. Timepoint: 48 hours. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2019-07-16 Ù…Ethics Committee of Mazandaran University of Medical Sciences Emam Khomeini hospital, Amir Mazandarani Ave Sari Mazandaran Iran (Islamic Republic of)