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IRCT20231112060025N1 IRCT 2023-12-04 Ghoum University of Medical Sciences "comparative effect of Ibuprofen and ketorolac in Renal colic" A comparative study of the effect of intravenous ibuprofen and intravenous ketorolac in controlling the pain of renal colic patients . 2023-12-22 anticipated 76 Complete https://irct.ir/trial/73710 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In both groups, the injection will be done as a single-dose intravenous infusion for 30 minutes with cardiac and respiratory monitoring, Randomization description: After explaining the objectives of the study to the patients and obtaining informed consent, the patients are divided into two groups using the balanced block random sampling method.Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website, Blinding description: In this study ; For the patient and the health personnel (who are responsible for the patient's care), an explanation will be given about both drugs included in the study, and the possible benefits and side effects of each injection will be explained. However, the patient and the health personnel about which of the two drugs will be prescribed; In the two study groups, they will be unaware of which drug; will be injected for the patient; are informed. 3 Renal colice. Intervention 1: intervention group: including 38 patients; 30 mg intravenous Ketorlak will be administered as a single-dose intravenous infusion for 30 minutes with cardiac and respiratory monitoring. Intervention 2: Intervention group: 38 people intravenous ibuprofen 400 mg will be injected in both groups as a single dose intravenous infusion for 30 minutes along with cardiac and respiratory monitoring. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Atefe NoorMohammadi
Shahid Beheshti street
Qom Iran (Islamic Republic of) ۳۷۱۹۹۶۵۷۵۵ +98 25 3661 0690 Atefenrm5@gmail.com Ghoum University of Medical Sciences scientific Mohammad Shahidi
Shahid Beheshti street
Qom Iran (Islamic Republic of) ۳۷۱۹۹۶۵۷۵۵ +98 25 3612 2000 Atefenrm5@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients with flank pain (renal colic) who have Definitive diagnosis of renal colic with imaging findings by non-contrast CT scan or ureteral ultrasound. Age between 18 and 60 years 18 years 60 years Both History of renal failure Pregnant women History of liver disease History of gastrointestinal disease such as active GI bleeding History of heart disease History of sensitivity to NSAID N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs intervention group: including 38 patients; 30 mg intravenous Ketorlak will be administered as a single-dose intravenous infusion for 30 minutes with cardiac and respiratory monitoring. Intervention group: 38 people intravenous ibuprofen 400 mg will be injected in both groups as a single dose intravenous infusion for 30 minutes along with cardiac and respiratory monitoring. Severity of pain caused by renal colic using a numerical scale. Timepoint: at minute zero; 20 minutes after injection; 60 minutes after injection. Method of measurement: VAS scale. Time to release and relieve pain. Timepoint: at minute zero; 20 minutes after injection; 60 minutes after injection. Method of measurement: Pre-designed questionnaire. Ghoum University of Medical Sciences Approved 2023-01-30 Research Ethics Committees of Qom University of Medical Sciences No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd Qom Ghoum Iran (Islamic Republic of)