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IRCT20150216021098N5 IRCT 2018-04-19 Mashhad University of Medical Sciences Comparison of paracetamol and ketorolac on pain management in patients with opium abuse undergoing cardiac surgery Comparison of the effect of paracetamol and ketorolac on pain management in patients with non-synthetic opium abuse undergoing off pump Coronary artey bypass grafting 2018-04-21 anticipated 100 Complete https://irct.ir/trial/30402 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly assigned to either group using randomization numbers table and will receive the intervention accordingly, Blinding description: After explaining the study method, interventions, and the administered drugs, the participants in either pararcetamol or ketorolac group, the outcome assessor, and the data analyzer will be blind to the administered drug. The patients do not know which drug is going to be used. The outcome assessors do not know which drug is going to be used. The data analyzer does not know which drug is going to be used. N/A Coronary artery bypass grafting. Intervention 1: Intervention group 1: In the paracetamol group, the patients receive the drug 15 mg/kg at maximum 1 gram intravenously every 6 hours after arrival at ICU for 24 hours. Intervention 2: Intervention group 2: In ketorolac group, the patients receive the drug 0.5 mg/kg at maximum 60 mg intravenously every 6 hours after arrival at ICU for 24 hours. 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 The participants data will not be shared until the participants and the institute permit.
public Shahram Amini
Ebne sina street
Mashhad Iran (Islamic Republic of) 9137913316. +98 51 3180 2315 aminish@mums.ac.ir Maragheh University of Medical Sciences scientific Shahram Amini
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 5209 Aminish@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Adult older than 18 years undergoing off-pupm CABG ASA class 2 or 3 Non-synthetic opium abuse 18 years no limit Both Allergy to either of drugs Consumption of either drugs in the past 48 hours Preoperative use of nephrotoxic drugs Presence of renal insufficiency or plasma creatinine higher than 1.3 mg/dL History of gastrointestinal disease or bleeding, peptic ulcer, perioperative bleeding Hepatic insufficiency Ejection fraction less than 40% Postoperative need for intraaortic ballon pump perioperative hemodynamic compromise Unwanter intraoperative events including arrhythmia or cardiac arrest refusal to stay in the study T82 Complications of cardiac and vascular prosthetic devices, implants and grafts Treatment - Drugs Treatment - Drugs Intervention group 1: In the paracetamol group, the patients receive the drug 15 mg/kg at maximum 1 gram intravenously every 6 hours after arrival at ICU for 24 hours. Intervention group 2: In ketorolac group, the patients receive the drug 0.5 mg/kg at maximum 60 mg intravenously every 6 hours after arrival at ICU for 24 hours Pain intensity. Timepoint: every one and four hours in the first and second days, respectively after intervention. Method of measurement: Observation (CPOT0 and questioning (NRS) scores. Additional analgesic requirement. Timepoint: every one hour on the first day and every 4 hours on the second day. Method of measurement: Recording the amount of administered fentanyl in micro-gram. Frequency of acute kidney injury. Timepoint: Every day after intervention until discharge from the hospital. Method of measurement: AKIN criteria. Frequency of gastrointestinal bleeding and discomfort. Timepoint: every day after intervention until discharge from the hospital. Method of measurement: Observation and questioning. Mashhad University of Medical Sciences Approved 2017-12-13 Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)