]>
IRCT20230718058838N1 IRCT 2023-07-20 Khoram-Abad University of Medical Sciences Comparison of the Effectiveness of Intranasal Ketamine, Intravenous Morphine Sulfate, and Intravenous Ketorolac in Reducing the Pain of the Renal Colic Patients in the Emergency Department of Shohadeye Ashayer Hospital of Khorramabad: A Randomized Controlled Trial Comparison of the Effectiveness of Intranasal Ketamine, Intravenous Morphine Sulfate, and Intravenous Ketorolac in Reducing the Pain of the Renal Colic Patients 2023-08-23 anticipated 99 Complete https://irct.ir/trial/71402 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will stratify the patient into three groups according to the severity of the pain (1 to 4, 5 to 7 & 8 to 10), then we will use block randomization in each of these groups for finding the members of each prescription group, Blinding description: The patients will be randomly divided into three groups. For patients in group A, 1mg/kg of ketamine intranasally and 5cc of normal saline intravenously will be prescribed, in patients in group B, 0.1mg/kg of morphine sulfate intravenously and 5cc of normal saline intranasally will be used, and in patients in group C, 60mg of ketorolac intravenously and 5cc of normal saline intranasally will be injected. In injecting these drugs, a group of nurses will prepare the prescribed drugs in 5cc syringes according to the pre-designed block randomization method, and if the drug fills less than the syringe volume, they will dilute it with distilled water to reach 5cc volume and without informing the contents, only by specifying the route of drug injection, they will provide it to another group of nurses who are responsible for injecting the drug. It should be noted that patients will not be informed of the type of drug prescribed. The pain level of patients before drug injection and at minutes 15, 30, 45 and 60 after drug administration will be evaluated based on the VAS scale, the responsibility of pain score assessment in all patients will be performed by an experienced specialist physician who is not aware of the type of drug prescribed in the patient and finally the difference between the VAS score before drug administration and the specified times after drug administration will be used as a criterion for evaluating the success of drugs in reducing pain. 4 Renal colic. Intervention 1: Intervention group: Intranasal injection of 1mg/kg ketamine & 5cc intravenous normal saline. Intervention 2: Control group: Intravenous injection of 0.1mg/kg ketamine & 5cc intranasal normal saline. Intervention 3: Control group: Intravenous injection of 60mg ketorolac & 5cc intranasal normal saline. Yes - There is a plan to make this available What will be shared: The whole data can be shared after making individuals unidentifiable. When: Access start 6 months after publication of results. To whom: Access is available for academic and scientific workers. Conditions: Using the data is not allowed by others. Where to obtain: Access to data is possible by sending an email to the research committee of Lorestan University of Medical Sciences. How to obtain: After sending an email to the research committee of Lorestan University of Medical Sciences via academic email, the relevant data will be sent to the applicant within a maximum of one week Comments:
public Seyed Mobin Nouredini
Keshavarzi Alley, Police Ave, Khorramabad
Khorramabad Iran (Islamic Republic of) 6815833382 +98 66 3335 1530 mobinnouredini@gmail.com Khoram-Abad University of Medical Sciences scientific Seyed Mobin Nouredini
Keshavarzi Alley, Police Ave, Khorramabad
Khorramabad Iran (Islamic Republic of) 6815833382 +98 66 3335 1530 mobinnouredini@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) More than 18 years old Renal colic symptoms existence: unilateral or bilateral flank pain Sign of nephrolithiasis in CT scan or Ultrasound imaging 18 years no limit Both Pregnant female Opioid addiction Sensitivity to Morphine sulfate, Ketorolac or Ketamine Nasal obstruction Systolic blood pressure upper than 180mmHg or lesser than 90mmHg Respiratory distress Loss of conscious Patient with no enough cooperation Past medical history of GI bleeding Past medical history of Asthma Medication using during last 48hours N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intranasal injection of 1mg/kg ketamine & 5cc intravenous normal saline Control group: Intravenous injection of 0.1mg/kg ketamine & 5cc intranasal normal saline Control group: Intravenous injection of 60mg ketorolac & 5cc intranasal normal saline Pain severity in the renal colic patients. Timepoint: Before drug injection and 15, 30, 45 & 60 minute after injection. Method of measurement: Visual Analogue Scale. Khoram-Abad University of Medical Sciences Approved 2023-07-15 Ethics committee of Lorestan University of Medical Sciences Moalem ave Khorramabad Lorestan Iran (Islamic Republic of)