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IRCT20220807055631N1 IRCT 2022-08-30 Ahvaz University of Medical Sciences Effect of melatonin on opioids used in patients undergoing laparotomy The effect of sublingual melatonin on the use of opioids used in patients undergoing laparotomy admitted to the ICU 2022-09-23 anticipated 60 Complete https://irct.ir/trial/65175 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(30)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group and the second 30 people will place in the second group. A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomization. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment, Blinding description: In this study, doctors, nurses, those responsible for data collection and those who evaluate the results will be blinded. The appearance of the placebo is similar to the melatonin pill, and the preparation of the drugs is done by the nurse away from the eyes of the patients. Also, intervention (receiving melatonin or placebo) and evaluation of patients is done by a doctor who does not know about the patient's grouping. The statistical analyzer of the results will not know about the patient grouping. 3 Appendicitis. Intervention 1: Intervention group:Intervention group: Patients will receive 5 mg of sublingual melatonin tablets (the company...) at 9:00 p.m. every night upon entering the intensive care unit. Medication prescription for 7 days in patients in the intensive care unit. continues. Intervention 2: Control group: Patients will receive a placebo pill with the same shape and appearance as melatonin at 9:00 PM every night upon entering the intensive care unit. Placebo administration continues for 7 days in patients in the intensive care unit. Yes - There is a plan to make this available What will be shared: Publishing as an article When: always To whom: All researchers Conditions: To be presented in scientific texts under conditions of confidentiality and copyright Where to obtain: Dr Negin Ayoubzadeh How to obtain: Email to the responsible person Comments:
public Negin Ayoubzadeh
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 neginayoubzadeh@hotmail.com Ahvaz University of Medical Sciences scientific Negin Ayoubzadeh
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 neginayoubzadeh@hotmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years Patients undergoing laparotomy surgery requiring hospitalization in the intensive care unit for more than 48 hours 18 years no limit Both Presence of liver failure (liver enzyme more than three times the normal limit) Renal failure (GFR<60) History of brain tumor History of sensitivity to melatonin K37 Unspecified appendicitis Prevention Placebo Intervention group:Intervention group: Patients will receive 5 mg of sublingual melatonin tablets (the company...) at 9:00 p.m. every night upon entering the intensive care unit. Medication prescription for 7 days in patients in the intensive care unit. continues. Control group: Patients will receive a placebo pill with the same shape and appearance as melatonin at 9:00 PM every night upon entering the intensive care unit. Placebo administration continues for 7 days in patients in the intensive care unit. The need to receive opioids. Timepoint: daily during ICU stay. Method of measurement: The need for narcotics (and drug dosage) based on the severity of the patient's pain and the doctor's diagnosis. The need to receive antibiotics. Timepoint: daily during ICU stay. Method of measurement: Prescribing antibiotics based on doctor's diagnosis. Changes in the amount of pain. Timepoint: daily during ICU stay. Method of measurement: based on visual analog scale (VAS). Possible side effects. Timepoint: During ICU stay. Method of measurement: Based on the patient's examination and symptoms. Ahvaz University of Medical Sciences Approved 2022-05-28 Ethics committee of Golestan Hospital of Jondi Shapoor of Ahwaz University of Medical Sciences Golestan Ave., farvardin St. Ahwaz Khouzestan Iran (Islamic Republic of)