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IRCT20201018049062N1 IRCT 2020-11-18 Zahedan University of Medical Sciences Effect of two doses of ketorolac in the treatment of acute renal colic pain Comparison of the effectiveness of two intravenous doses of ketorolac for the treatment of acute renal colic in patients referred to the emergency department 2020-12-05 anticipated 160 Complete https://irct.ir/trial/51995 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly divided into two groups of 8 blocks. Thus, according to the order of patient placement in the group of 8 in each block, 4 patients from group A and 4 patients from group B will be randomly placed. Then, when referring, a block is selected, and based on the patient's entry order and the card row in each block, the patient will be assigned to the relevant group, Blinding description: The drug groups will be prepared in doses of 15 mg (group A) and 30 mg (group B) in 5cc syringes with the same appearance. At the beginning of the hospitalization, patients are randomly divided into two groups receiving ketorolac (15 or 30 mg ketorolac). In one group, ketorolac at a dose of 15 mg (group A) is administered intravenously and in the other group, ketorolac at a dose of 30 mg (group B) is used intravenously. The classification of patients and the type of medication used for the people involved in the study are blinded and the researcher evaluating the patients is not aware of the drug group prescribed to patients during the study. For this purpose, all syringes of both groups have the same appearance and volume with the same frequency of use in both groups. Other common treatments also apply to both groups. Therefore, the study will be conducted in a double-blind manner. 2 Renal Colic. Intervention 1: Intervention group: Ketorolac group with a dose of 15 mg stat. Intervention 2: Intervention group: Ketorolac group with a dose of 30 mg stat. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 5 months after the results are published To whom: The data from this study will be available to academic and scientific researchers as well as people working in industry (if needed) Conditions: The data from the present study will be usable for other researchers, provided the source and citation are preserved. Where to obtain: Applicants can send their application through the mailing address sheida.mehrdad@zaums.ac.ir Dr. Sheida Mehrdad. How to obtain: After sending a request to receive the documents to Dr. Sheida Mehrdad, he will check the identity of the applicant and the type of application and will send the documents in less than two weeks Comments:
public Sheida Mehrdad
Khatam Al-Anbia Hospital, Jam Jam Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2155 sheida.mehrdad@zaums.ac.ir Zahedan University of Medical Sciences scientific Sheida Mehrdad
Khatam Al-Anbia Hospital, Jam Jam Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2155 sheida.mehrdad@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) All patients over 16 years of age admitted to the emergency department due to renal colic 16 years 70 years Both age older than 70 y/o Women during pregnancy or lactation Gastrointestinal problems such as gastritis, peptic ulcer or acute bleeding Allergy to nonsteroidal anti-inflammatory drugs Unstable vital signs (systolic BP less than 90 or more than 180 mm Hg, HR less than 50 or more than 150) Patients with a history of analgesia N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: Ketorolac group with a dose of 15 mg stat Intervention group: Ketorolac group with a dose of 30 mg stat Pain intensity score on a numerical pain scale. Timepoint: Measurement of pain intensity at the time of referral (before drug injection), 20, 40 and 60 minutes after drug injection. Method of measurement: Visual Analogue Scale. Satisfaction with the type of treatment. Timepoint: 60 minutes after receiving the drug. Method of measurement: 5 point scale. Side effects. Timepoint: 60 minutes after drug injection. Method of measurement: Physical examination. The need for a life-saving dose. Timepoint: After establishing painlessness. Method of measurement: Frequent administration of morphine rescue dose. Heart Rate. Timepoint: 20, 40 and 60 minutes after injection. Method of measurement: Number on monitoring. Average Blood Pressure. Timepoint: 20, 40 and 60 minutes after injection. Method of measurement: Number on monitoring. Zahedan University of Medical Sciences Approved 2020-10-11 Ethics committee of Zahedan University of Medical Sciences Dr. Hesabi Square - Campus of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)