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IRCT20220516054869N3 IRCT 2022-11-18 Zahedan University of Medical Sciences Comparison of the effect of intravenous morphine with intravenous ketorolac in relieving pain in patients with limb fractures referred to the emergency department Comparison of the effect of intravenous morphine with intravenous ketorolac in relieving pain in patients with limb fractures referred to the emergency department of Khatam An-bia Hospital in Zahedan in 2022 2022-11-22 anticipated 40 Complete https://irct.ir/trial/66779 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age (15-30, 31-45 and 46-60) in the order of entry. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2, Blinding description: In this research, the triple-blind method is used. So that the person responsible for recording the results, the patient and the data analyst will not be aware of the intended intervention.Both drugs in the intervention and control groups are injected intravenously for 5 minutes through a covered syringe, and the patient does not know the contents of the syringe. 3 Pain management in patients with limb fractures. Intervention 1: Intervention group: Intravenous ketorolac 30 mg, 1 cc of Caspian Daru Company, which is administered intravenously to the patient within 5 minutes after the patient enters the study according to the study protocol. Intervention 2: Control group: 5 cc of intravenous morphine of pakhsh daroo company equivalent to 5 mg will be administered intravenously within five minutes after the patient enters the study and according to the study protocol. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: Access starts one year after results are published To whom: Researchers working in academic and scientific institutions Conditions: The use of documentation for research exploitations in the field of drug therapy is unimpeded only for researchers. Where to obtain: Correspondence with the email address ali.abdolrazaghnejad@zaumas.ac.ir. How to obtain: After sending the applicant's application and receiving the email, if the applicant is eligible, the data files will be sent to the email address. Comments:
public Ali Abdolrazaghnejad
Daneshgah Blvd
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3323 2890 ali.abdorazzagh@gmail.com Zahedan University of Medical Sciences scientific Ali Abdolrazaghnejad
Daneshgah Blvd
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3323 2890 ali.abdorazzagh@gamil.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Existence of definitive limb fracture based on radiography and pain intensity based on visual analog scale more than 4 15 years 60 years Both Lack of informed consent Hemodynamic instability Underlying pulmonary problems, History of taking painkillers or narcotic drugs History of liver or kidney disease Head injury Pregnancy Age below 15 years and above 60 years G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Intervention group: Intravenous ketorolac 30 mg, 1 cc of Caspian Daru Company, which is administered intravenously to the patient within 5 minutes after the patient enters the study according to the study protocol. Control group: 5 cc of intravenous morphine of pakhsh daroo company equivalent to 5 mg will be administered intravenously within five minutes after the patient enters the study and according to the study protocol. Pain score. Timepoint: Before the intervention and 10, 20, 40, 60, 75 minutes after the intervention. Method of measurement: Visual Analogue Scale (VAS). Respiratory depression. Timepoint: 10, 20, 40, 60, 75 minutes after the intervention. Method of measurement: Having or not having a side effect after the intervention. Headache. Timepoint: 10, 20, 40, 60, 75 minutes after the intervention. Method of measurement: Having or not having a side effect after the intervention. Dizziness. Timepoint: 10, 20, 40, 60, 75 minutes after the intervention. Method of measurement: Having or not having a side effect after the intervention. Drowziness. Timepoint: 10, 20, 40, 60, 75 minutes after the intervention. Method of measurement: Having or not having a side effect after the intervention. Zahedan University of Medical Sciences Approved 2022-10-25 Ethics Committee of Zahedan University of Medical Sciences Daneshgah blvd Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)