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IRCT20200422047163N1 IRCT 2020-05-01 Sanandaj University of Medical Sciences Analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients Comparison of analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients 2019-12-22 anticipated 200 Complete https://irct.ir/trial/47370 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly divided into groups A and B using ten-person blocks. Based on time for patients referring to emergency room, the first ten patients will be allocated to group A and the next ten will be allocated to group B.This continues until the end of sampling, Blinding description: This is a double blind clinical trial. Patients are unaware of the grouping. Also, the person who is following the patient in terms of response to treatment and pain change (researcher student), does not know the injected drug belongs to intervention or control group. 3 Renal colic. Intervention 1: Intervention group: For patients in the intervention group, 0.016 mg / kg midazolam and 0.4 mg / kg ketamine based on body weight are injected. Intervention 2: Control group: For patients in the control group, 30 mg Ketorolac and 15 mg apotel based on body weight are injected. Yes - There is a plan to make this available What will be shared: Data on the main outcome of the study can be shared. When: One year after the publication the data will be available. To whom: Researchers working in academic and scientific institutions Conditions: Meta-analysis is allowed on the data of this study. Where to obtain: Dr. Anvar Bahrami, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran , Email: bahramianvar92@gmail.com How to obtain: After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email. Comments:
public Anvar Bahrami
Kowsaer Hospital, Boranaldin Hamdi Ave.,Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 66179-83476 +98 87 3361 1231 bahramianvar92@gmail.com Sanandaj University of Medical Sciences scientific Leila Azizkhani
Kowsaer Hospital, Boranaldin Hamdi Ave.,Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 66179-83476 +98 87 3361 1231 leila433@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Renal colic patients whose initial pain is greater than or equal to 8 according to the Numeric Ranking Scale system 18 years 65 years Both Patients with schizophrenia, asthma, cardiovascular disease and hypertension Significant head trauma Pregnancy or suspected Active lung infection Hemodynamic instability Respiratory distress or active hypoxemia Sensitivity to acetaminophen Severe liver failure Active liver disease Active gastric ulcer or its history Any suspicion of active bleeding Sensitivity to NSAIDs or aspirin Patients with kidney disease Taking painkillers (NSAIDs, acetaminophen, opioids) in the last 4 hours Glaucoma The patient's refusal to continue participating in the study Normal urine analysis (UA) Inability to understand the concept of NRS system N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Intervention group: For patients in the intervention group, 0.016 mg / kg midazolam and 0.4 mg / kg ketamine based on body weight are injected. Control group: For patients in the control group, 30 mg Ketorolac and 15 mg apotel based on body weight are injected. Pain. Timepoint: One, five, ten, fifteen, thirty and forty-five minutes after drug injection. Method of measurement: It will be determined based on the Numeric Rating Scale system. Sanandaj University of Medical Sciences Approved 2019-09-08 Ethics committee of Kurdistan University of Medical Sciences Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)