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IRCT20210511051268N1 IRCT 2021-05-13 Tehran University of Medical Sciences The effect of acetaminophen on propofol injection pain The effect of premedication with oral acetaminophen on the prevention of localized pain from intravenous injection of propofol as induction agent in patients under general anesthesia 2021-06-22 anticipated 150 Complete https://irct.ir/trial/56227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Restricted randomization is done using permuted block randomization method, with six blocks. Randomization was performed using the website www.randomization.com. The method of concealment is to use opaque envelopes sealed in random sequence, Blinding description: Both the patient and an independent evaluator (in charge of anesthesia) and the researcher and data analyzer and the outcome evaluator are not aware of the type of oral medication. Placebo and paracetamol are the same in shape, size, color and weight. 3 Local Pain due to intravenous injection of propofol. Intervention 1: Intervention group: P500 group (patients with 500 mg of oral paracetamol) will receive medication 1 hour before transfer to the operating room. Each patient receives 1 placebo tablet and 1 paracetamol 500 mg tablet. (Because in the other intervention group, patients take 2 acetaminophen pills, so here they take one medicine pill and one placebo pill) None of them will receive any other analgesic or sedative. Aria 500 mg acetaminophen tablet is a product of Aria Pharmaceutical Company. Immediately after injecting a quarter of the propofol induction dose, the patient's local pain at the injection site is assessed by the VNRS numerical criterion and the patient scores from 0 to 10. Intervention 2: Control group: The placebo group receives the drug 1 hour before transfer to the operating room. Each patient receives 2 placebo tablets. (Because in one intervention group, patients take 2 acetaminophen pills, so here they take two placebo pills). None of them will receive any other analgesic or sedative. Immediately after injecting a quarter of the propofol induction dose, the patient's local pain at the injection site is assessed by the VNRS numerical criterion and the patient scores from 0 to 10. Intervention 3: Intervention group: Intervention group: P1000 group (patients with 1000 mg of oral paracetamol) receive medication 1 hour before transfer to the operating room. Each patient receives 2 tablets of 500 mg paracetamol. None of them will receive any other analgesic or sedative. Aria 500 mg acetaminophen tablet is a product of Aria Pharmaceutical Company. Immediately after injecting a quarter of the propofol induction dose, the patient's local pain at the injection site is assessed by the VNRS numerical criterion and the patient scores from 0 to 10. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Access is free for everyone Conditions: Access is free for everyone Where to obtain: Person in charge of the project / Seyed Mohsen Mousavi sm.mousavi.md.anesthesiology@gmail.com How to obtain: Immediately after contacting the project manager Comments:
public Seyed Mohsen Mousavi
Tehran / Shahrak-e-Gharb / Dadman Blvd. / Sepehr St. / No. 117 / Unit 6
Tehran Iran (Islamic Republic of) 1468734117 +98 21 8836 3149 sm.mousavi.md.anesthesiology@gmail.com Tehran University of Medical Sciences scientific Seyed Mohsen Mousavi
Tehran / Shahrak-e-Gharb / Dadman Blvd. / Sepehr St. / No. 117 / Unit 6
Tehran Iran (Islamic Republic of) 1468734117 +98 21 8836 3149 sm.mousavi.md.anesthesiology@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients for whom propofol is used as an induction of anesthesia 18 years 60 years Both Weight less than 50 kg Chronic pain in any area of ​​the body High blood pressure Cardiovascular disease Cerebrovascular disease Difficulty communicating (even if there is a marked drop in level of consciousness with the initial injection dose) Cirrhosis Abnormal liver function test results (AST and ALT more than twice normal) Kidney failure or creatinine clearance greater than 1.2 Allergy to acetaminophen Allergy to propofol Patients in whom propofol is not used to induce anesthesia Those who do not have a venous catheter in the back of the hand Those whose catheter size is not 20G those for whom we have to use rapid sequence induction for their anesthesia M79.643 Pain in unspecified hand Treatment - Drugs Placebo Treatment - Drugs Intervention group: P500 group (patients with 500 mg of oral paracetamol) will receive medication 1 hour before transfer to the operating room. Each patient receives 1 placebo tablet and 1 paracetamol 500 mg tablet. (Because in the other intervention group, patients take 2 acetaminophen pills, so here they take one medicine pill and one placebo pill) None of them will receive any other analgesic or sedative. Aria 500 mg acetaminophen tablet is a product of Aria Pharmaceutical Company. Immediately after injecting a quarter of the propofol induction dose, the patient's local pain at the injection site is assessed by the VNRS numerical criterion and the patient scores from 0 to 10. Control group: The placebo group receives the drug 1 hour before transfer to the operating room. Each patient receives 2 placebo tablets. (Because in one intervention group, patients take 2 acetaminophen pills, so here they take two placebo pills). None of them will receive any other analgesic or sedative. Immediately after injecting a quarter of the propofol induction dose, the patient's local pain at the injection site is assessed by the VNRS numerical criterion and the patient scores from 0 to 10. Intervention group: Intervention group: P1000 group (patients with 1000 mg of oral paracetamol) receive medication 1 hour before transfer to the operating room. Each patient receives 2 tablets of 500 mg paracetamol. None of them will receive any other analgesic or sedative. Aria 500 mg acetaminophen tablet is a product of Aria Pharmaceutical Company. Immediately after injecting a quarter of the propofol induction dose, the patient's local pain at the injection site is assessed by the VNRS numerical criterion and the patient scores from 0 to 10. 11-point verbal numerical rating score (VNRS) for pain caused by propofol injection. Timepoint: Measuring the amount of pain right after injecting a quarter of the induction dose. Method of measurement: 11-Point Verbal Numerical Ranking (VNRS). Tehran University of Medical Sciences Approved 2020-09-02 Ethics committee of Tehran University of Medical Sciences Enghelab St., Ghods St., Poursina St. Tehran Tehran Iran (Islamic Republic of)