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IRCT20220526054991N1 IRCT 2022-06-13 Islamic Azad University The effect of Pentoxifylline in the treatment of pain in patients undergoing Laminectomy The effect of preoperative Pentoxifylline administration on postoperative pain inpatients undergoing Laminectomy 2022-06-22 anticipated 72 Complete https://irct.ir/trial/63816 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to two groups by simple randomization method they are divided. How to select people and place them in dual groups It will be random, so after confirming the necessary conditions for the direction of Entering the study selected patients consecutively, the first patient in The first group will put the second patient in the second group. And so on. Again, the groups will take each patient to the limit. The number of samples in the intervention and control groups is equal, Blinding description: Drugs studied by a neurosurger who does not have participated in the scheme , is prepared and in closed envelopes with the patient's code written on it Envelopes are preserved in the neurosurgical ward one day before surgery ; Day of surgery;The day after surgery by neurosurgeve that type of medication and The group where the patient is located does not know it opens. Nurses Patients and pain assessors are also unaware of the type of drug and the patient group. N/A pain after Laminectomy. Intervention 1: Intervention group: Intervention group: In this group, 36 eligible patients who are scheduled to undergo laminectomy and have been randomly assigned to this group, one capsule of 400 mg pentoxylline product of Farabi Pharmaceutical Company will be given to the patient orally one hour before surgery, the number of tablets will be taken only once. And the possible complications will be monitored by attending the patient's bedside. Intervention 2: Control group: In this group, 36 eligible patients who are scheduled to undergo laminectomy and have been randomly assigned to this group will be given a 400 mg pentoxylline capsule of Farabi Company whose contents are empty and filled with starch, one hour before surgery will be given to the patient orally, the capsule will be prepared from Farabi Pharmaceutical Company. The number of times you take the pill will only be once. And the possible complications will be monitored by attending the patient's bedside. Yes - There is a plan to make this available What will be shared: Demographic data and results of the research When: After the final report (2023) To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Observing the author's right Where to obtain: Call the inserted email and number. How to obtain: After submitting the request and reviewing it in the shortest possible time, they will be answered (one week) Comments:
public Hamid Hobobati
No.2 ,Saadat Ave.,Razmandegan Town
Yazd Iran (Islamic Republic of) 8915134714 +98 35 3820 4556 hh1358@gmail.com Islamic Azad University scientific Hamid Hobobati
No.2 ,Saadat Ave.,Razmandegan Town
Yazd Iran (Islamic Republic of) 34714_89151 +98 35 3820 4556 hh1358@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients who are candidates for Laminectomy surgery and are over 15 years old. 15 years 75 years Both Smoker Patients who have alcohol or substance abuse liver disease, diabetes, immunodeficiency (use of immunosuppressive drugs or chemotherapy), AIDS, acute bowel disease, cancer, and dialysis patients. Pregnant Children under the age of 15 and people older than 75 who are getting information from them is hard. G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: In this group, 36 eligible patients who are scheduled to undergo laminectomy and have been randomly assigned to this group, one capsule of 400 mg pentoxylline product of Farabi Pharmaceutical Company will be given to the patient orally one hour before surgery, the number of tablets will be taken only once. And the possible complications will be monitored by attending the patient's bedside. Control group: In this group, 36 eligible patients who are scheduled to undergo laminectomy and have been randomly assigned to this group will be given a 400 mg pentoxylline capsule of Farabi Company whose contents are empty and filled with starch, one hour before surgery will be given to the patient orally, the capsule will be prepared from Farabi Pharmaceutical Company. The number of times you take the pill will only be once. And the possible complications will be monitored by attending the patient's bedside. Severity of back pain. Timepoint: One hour before surgery, one hour after surgery and 24 hours after surgery. Method of measurement: Measurement of back pain based on Visual Analogue Scale. Islamic Azad University Approved 2022-02-21 Ethics committee of Islamic Azad University_ Yazd Branch Islamic Azad University, Alam Square,Shohadaye Gomnam Blvd Yazd Yazd Iran (Islamic Republic of)