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IRCT20180428039443N2 IRCT 2021-04-06 Tehran University of Medical Sciences Pain Relieving Effect of Glycerol Trinitrate (GTN) in Renal Colic Pain Relieving Effect of Glycerol Trinitrate (GTN) in Renal Colic: a Randomized Placebo-Controlled Trial 2021-02-12 anticipated 100 Complete https://irct.ir/trial/53987 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will be a blind, randomized, placebo-controlled three-way trial that will be performed in the internal ward of Shariati Hospital, Tehran, Iran. Patients entered the study after signing the informed consent form. Researchers will adhere to the Helsinki Declaration of Principles during the study, Randomization description: The random number sequences of volunteers are made by the Sealed Envelope | Randomization site. Using random quadrilateral blocks, the random chain is created at first by the number of sample volumes, Blinding description: Because of the nature of the outcome of the disease (pain), blindness or blindness does not disclose the study. However, the final data for analysis will be coded and analyzed without the knowledge of the treatment group. Data collection authorities and those who evaluate the outcome, Data Safety and Monitoring Committee, and those who prepare the draft article, are kept blind to the studied groups. N/A Renal Colic. Intervention 1: Intervention group: Patients who receive, in addition to standard treatment Glycerol Trinitrate (GTN). GTN sprays contain 0.4 mg of trinitroglycerin. Intervention 2: Control group: Patients undergoing standard treatment and receiving placebo. Placebo sprays will contain exponents to have a similar odor to the patients receiving them until they look exactly the same. We will record the number for each package and content as a placebo or GTN spray. Yes - There is a plan to make this available What will be shared: All patient information documented data without identification. The information entered will eventually be entered in the database of the database. When: Data will be available upon national and international patenting process completion of the study. To whom: All interested researchers Conditions: There is no specific condition. Where to obtain: Dr. Ahmad Reza Dehpour How to obtain: The procedure outlined by the Ethics Committee of Tehran University of Medical Sciences Comments:
public Ahmad Reza Dehpour
Medical School, PourSina St., Tehran, 1417613151, Iran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 3652 dehpour@yahoo.com Tehran University of Medical Sciences scientific Ahmad Reza Dehpour
Medical School, PourSina St., Tehran, 1417613151, Iran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 3652 dehpour@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients over 16 years of age, who are clinically diagnosed by an emergency physician with imaging (ultrasound or CT scan) to have renal colic and have a pain level higher than 5 on the VAS scale). Patients who have treated themselves or had side effects from diseases such as gastrointestinal, heart, kidney or liver are not included. The following will be considered as exclusion criteria: symptoms of peritoneal irritation, pregnancy and lactation, fever or hypotension; History of sildenafil, tadalafil, vardenafil, antihypertensive drugs, aspirin, antimuscarinic, alcohol, ergotamine, haloperidol or phenothiazine during the last 4 weeks, 16 years no limit Both allergic reaction to GTN; Severe clinical anemia; Recent concussion or any damage to the central nervous system, malnutrition, hypothyroidism; Hypothermia; And drug abusers. N23 Unspecified renal colic Treatment - Drugs Placebo Intervention group: Patients who receive, in addition to standard treatment Glycerol Trinitrate (GTN). GTN sprays contain 0.4 mg of trinitroglycerin. Control group: Patients undergoing standard treatment and receiving placebo. Placebo sprays will contain exponents to have a similar odor to the patients receiving them until they look exactly the same. We will record the number for each package and content as a placebo or GTN spray. Pain Relieving. Timepoint: Pain will be measured again in patients after 5 minutes, and if the VAS pain is still more than 5, the patient will receive another 30 mg of ketorolac injection. Pain will be re-estimated 30 minutes after this dose, and if the patient has a VAS pain score higher than 5, the next dose of ketorolac will be injected. Method of measurement: Response to VAS treatment is defined as less than 5. Tehran University of Medical Sciences Approved 2021-01-29 Tehran University of Medical Sciences Medical School, PourSina St., Tehran, 1417613151, Iran Tehran Tehran Iran (Islamic Republic of)