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IRCT20171014036769N2 IRCT 2018-02-20 Shahid Beheshti Medical University Postoperative Pain Management of Obese Patient Undergoing Gastric Bypass Surgery. Title: Comparing The Effect Of Ketorolac and Morphine With Morphine Alone in Postoperative Pain Management of Obese Patient Undergoing Gastric Bypass Surgery. 2017-12-22 anticipated 72 Complete https://irct.ir/trial/27397 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are allocated in two groups by permuted block randomization method which the block size was assumed four. Also Allocation concealment will be ensured, by central telephone method and assigning 5 digit code to participants in each group by a person who is not aware of hypothesis, Blinding description: In this study, nurses in the operating room are not blinded. On the other hand data collector and outcome assessors will be blinded to the group of participants. Patient is blind to the group they are in. N/A Condition 1: Post Operative Pain. Condition 2: Morbid Obesity. Intervention 1: Intervention group: patients will receive PCA infusion of 0.4 mg morphine sulfate per hour and Apotel 1 gram intravenously every 12 hours plus 30 mg IV and 30 mg IM ketorolac and also 15 mg ketorolac IV every 6 hours. If VAS score is more than 49mm patient will receive Apotel 1 gram intravenous with maximum dose of 4 gram daily.If the patient feel nausea, 4 mg intravenous Ondansetrone will be administered. Intervention 2: Control group: patients in control group wil receive patient control analgesia (PCA) with infusion of 0.8 mg morphine sulfate per hour and Apotel 1 gram intravenous each 12 hours at the time they discharge from the recovery ward.If VAS score is more than 49mm patient will receive Apotel 1 gram intravenous with maximum dose of 4 gram daily.If the patient feel nauseated, 4 mg intravenous Ondansetrone will be administered. Undecided - It is not yet known if there will be a plan to make this available
public Dr Soodeh Tabashi
Erabi St., Yaman St., Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2592 school.of.medicine@sbmu.ac.ir Shahid Beheshti Medical University scientific Dr Noor Mohammad Arefian
Erabi St., Yaman St., Chamran highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2274 9201 narefian@yahoo.com Shahid Beheshti Medical University Iran (Islamic Republic of) Body Mass Index >40kg/m2 candidate for gastric bypass surgery Body mass Index > 35kg/m2 in addition to coexisting diseases such as diabetes, hypertension, renal disease, cardiovascular diseases ASA class : 1 or 2 no limit no limit Both reported Addiction to psychotropic drugs or substance abuse History of allergic reactions to drugs used in the study G89.18 E66 Other acute postprocedural pain Overweight and obesity Treatment - Drugs Treatment - Drugs Intervention group: patients will receive PCA infusion of 0.4 mg morphine sulfate per hour and Apotel 1 gram intravenously every 12 hours plus 30 mg IV and 30 mg IM ketorolac and also 15 mg ketorolac IV every 6 hours. If VAS score is more than 49mm patient will receive Apotel 1 gram intravenous with maximum dose of 4 gram daily.If the patient feel nausea, 4 mg intravenous Ondansetrone will be administered. Control group: patients in control group wil receive patient control analgesia (PCA) with infusion of 0.8 mg morphine sulfate per hour and Apotel 1 gram intravenous each 12 hours at the time they discharge from the recovery ward.If VAS score is more than 49mm patient will receive Apotel 1 gram intravenous with maximum dose of 4 gram daily.If the patient feel nauseated, 4 mg intravenous Ondansetrone will be administered. VAS (Visual Analogue Scale) pain score. Timepoint: Immediately after the surgrey, 6 , 12 , 24 hours later and at the time of discharge. Method of measurement: Pain score questionnaire. Post Operative Nausea and Vomiting. Timepoint: 0,6,12,24 hours after exiting recovery room. Method of measurement: questionnaire. Length of Stay. Timepoint: at the time of discharge. Method of measurement: questionnaire. Shahid Beheshti Medical University Approved 2017-02-14 Ethics committee of faculty of medicine, Shahid Beheshti Medical University Shahid Beheshti University of medical sciences, Shahid Aarabi st., Yaman Ave., Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)