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IRCT20210331050801N1 IRCT 2021-07-12 Esfahan University of Medical Sciences Comparison of the effect of Ibuprofen and Piroxicam on pain relief after surgery Comparison of the prophylactic effectiveness of intravenous Ibuprofen and intramuscular Piroxicam on pain intensity after lower abdominal surgery under general anesthesia 2021-08-01 anticipated 90 Complete https://irct.ir/trial/57225 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization method is used. Patients who have the inclusion criteria are selected sequentially so that the first 3 are considered as a block and Then, using random allocation software, they are randomly divided into 3 groups: ibuprofen, piroxicam and control. This process continues until 90 patients enter the study. Thus, we will have equally 30 patients in each group (ibuprofen, piroxicam and control), Blinding description: Participants in study are unaware of the type of drug being injected. An anesthesiologist, who has no role in data collecting, prepares the medication in same volume and injects them. The data collector and the person who evaluating the outcome are not aware of the grouping of patients and the type of injected drug But the data analyzer is informed. 3 Postoperative pain. Intervention 1: Intervention group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, 20 mg Piroxicam (made by Alborz daroo factory) is injected intramuscularly into patient who is going to have lower abdominal surgery. Intervention 2: Intervention group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, 400 mg Ibuprofen (made by Caspian factory) is injected intravenously into patient who is going to have lower abdominal surgery. Intervention 3: Control group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, Normal saline serum (With a volume equal to the other two group`s drug) is injected intravenously into patient who is going to have lower abdominal surgery. Yes - There is a plan to make this available What will be shared: all of data is potentially shareable after unidentifying individuals. When: Access period starts 6 months after the results are published. To whom: Researchers working in academic and scientific institutions Conditions: use in other studies Where to obtain: khalili@med.mui.ac.ir How to obtain: After sending email, the request is read and reviewed and then will be answered as soon as possible. Comments:
public Gholamreza Khalili
Al-Zahra hospital, Sofe Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1992 khalili@med.mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Khalili
Al-Zahra hospital, Sofe Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1992 khalili@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) ASA1 and ASA2 patient Patient aged 25 to 65 years Patients undergoing lower abdominal surgery No history of drugs, alcohol and benzodiazepine addiction No history of seizures, psychiatric problems, liver and kidney disease, gastrointestinal bleeding, peptic ulcer and Coagulation disorder No allergy to the drugs used in the study 25 years 65 years Both G89.18 Other acute postprocedural pain Prevention Prevention Placebo Intervention group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, 20 mg Piroxicam (made by Alborz daroo factory) is injected intramuscularly into patient who is going to have lower abdominal surgery. Intervention group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, 400 mg Ibuprofen (made by Caspian factory) is injected intravenously into patient who is going to have lower abdominal surgery. Control group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, Normal saline serum (With a volume equal to the other two group`s drug) is injected intravenously into patient who is going to have lower abdominal surgery. Intensity of postoperative pain. Timepoint: Immediately after consciousness in recovery and 2, 8, 12 and 24 hours after surgery. Method of measurement: visual analogue scale. The amount of opioid used in the first 24 hours after surgery. Timepoint: First 24 hours after surgery. Method of measurement: Reading the patient file. Blood pressure. Timepoint: At the beginning of surgery and then every 30 minutes during surgery. Method of measurement: Digital barometer. Heart rate. Timepoint: At the beginning of surgery and then every 30 minutes during surgery. Method of measurement: Pulse oximeter. Duration of stay in recovery. Timepoint: After leaving the recovery. Method of measurement: Minute. Extubation time. Timepoint: After extubation. Method of measurement: Minute. The first time of requesting opioid after surgery. Timepoint: After end of surgery. Method of measurement: Minute. Degree of patients' satisfaction with pain relief. Timepoint: 24 hours after surgery. Method of measurement: Use of visual analogue scale. Isfahan University of Medical Sciences Approved 2020-07-11 Ethics committee of Isfahan university of medical sciences Hezar jarib Ave, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)