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IRCT20200825048515N40 IRCT 2021-09-26 Shahre-kord University of Medical Sciences Comparison of the effect of ketorolac and morphine on pain control in patients with renal colic A comparative study of the effect of intravenous ketorolac and morphine on pain control in patients with renal colic 2019-10-23 anticipated 272 Complete https://irct.ir/trial/58847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 272 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly divided into two groups A (first intervention) and B (second intervention). Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: In this study, ketorolac and morphine, will be prepared by an emergency medicine specialist and placed in coded packages and delivered daily to the researcher, who will prescribe them without knowing the type of each drug. They do. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 2 Renal colic. Intervention 1: First intervention group: For patients in this group, morphine (Iran Darou Pharmaceutical Company) is administered intravenously at a dose of 1 mg/kg. Intervention 2: Second intervention group: For patients in this group, Ketorolac (Iran Darou Pharmaceutical Company) is administered intravenously at a dose of 30 mg. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyed Mehdi Pourafzali
Shahrekord University of Medical Sciences, Kashani street
Isfahan Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 e.poursadra@gmail.com Esfahan University of Medical Sciences scientific Seyed Mehdi Pourafzali
Shahrekord University of Medical Sciences, Kashani street
Isfahan Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 e.poursadra@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) age range of 16-65 years The definitive diagnosis of renal colic (with renal colic symptoms and the presence of stones confirmed by CT) The weight of 50-100 kg (for the effectiveness of the dose of 30 mg ketorolac) The pain intensity of equal to or more than 7 The non-drug addiction The patients’ consent to participate in the study 16 years 65 years Both Having a history of morphine or ketorolac allergy Pregnancy or suspected pregnancy Breastfeeding Having history of taking painkillers over the last 4 hours Having a history of underlying diseases Having traumatic eye or head injuries Having one kidney or a kidney transplant Having cerebral hemorrhage or the possibility of its occurrence Having mental disorders Having fibromyalgia Having vascular and brain lesions Having coagulation disorders, using angiotensin-converting enzyme (ACE) inhibitor or anticoagulants N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs First intervention group: For patients in this group, morphine (Iran Darou Pharmaceutical Company) is administered intravenously at a dose of 1 mg/kg. Second intervention group: For patients in this group, Ketorolac (Iran Darou Pharmaceutical Company) is administered intravenously at a dose of 30 mg. Pain score. Timepoint: At the beginning of the study and at 5, 15, 30, 60 and 90 minutes after the intervention. Method of measurement: Visual Analogue Scale (VAS). Mean Arterial Pressure. Timepoint: At the beginning of the study and at 5, 15, 30, 60 and 90 minutes after the intervention. Method of measurement: Monitoring device. Hear rate. Timepoint: At the beginning of the study and at 5, 15, 30, 60 and 90 minutes after the intervention. Method of measurement: Monitoring device. Shahrekord University of Medical Sciences Approved 2019-09-22 Ethics committee of Shahre-Kord University of Medical Sciences Shahrekord University Of Medical Sciences, Kashani Blvd Shahrekord Isfehan Iran (Islamic Republic of)