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IRCT20180129038549N12 IRCT 2021-06-21 Esfahan University of Medical Sciences Desmopressin in the treatment of renal colic Comparison of intranasal desmopressin and intranasal ketamine in pain control in patients with renal colic 2021-06-22 anticipated 135 Complete https://irct.ir/trial/56840 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the arrival of the patients to the emergency department, they are divided into 3 groups by a computer-generated random number table with 6 blocks. The selected subjects will be divided into each study group in a randomized block method using 6 rows of four blocks (ABCABC-BACBAC-ACBBCA-BCAACB-AABBCC-CCBBAA). Desmopressin group (A), Ketamine group (B) and placebo group (c). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined. All this will be done with software called Sealed Envelope, Blinding description: First, ketamine and placebo (distilled water) sprays are packaged similar to desmopressin spray and then numbered and given to the triage nurse. The nurse, doctor and patient do not know the contents of the ointment. 3 Renal colic. Intervention 1: Intervention group: They will be received nasal desmopressin at a dose of 40 mcg, equivalent to 2 puffs per nose, and ketorolac at a dose of 30 mg / ml. Effective treatment is when the pain is reduced by at least 50% of the initial pain or a score of 3 out of 10 VAS scores. Morphine will be given at a dose of 0.1 mg / kg if the patient's pain does not decrease effectively after 30 minutes of drug administration. Intervention 2: Intervention group: They will be received nasal ketamine at a dose of 1 mg/kg, and ketorolac at a dose of 30 mg / ml. Effective treatment is when the pain is reduced by at least 50% of the initial pain or a score of 3 out of 10 VAS scores. Morphine will be given at a dose of 0.1 mg / kg if the patient's pain does not decrease effectively after 30 minutes of drug administration. Intervention 3: Control group: They will be received nasal placebo, and ketorolac at a dose of 30 mg / ml. Effective treatment is when the pain is reduced by at least 50% of the initial pain or a score of 3 out of 10 VAS scores. Morphine will be given at a dose of 0.1 mg / kg if the patient's pain does not decrease effectively after 30 minutes of drug administration. Yes - There is a plan to make this available What will be shared: All of data after coding When: Accessibility after 2022 To whom: Everyone Conditions: For seemingly studies data released to academic chairman's Where to obtain: Isfahan University of Medical Sciences How to obtain: Emailing to farhad_heidari@med.mui.ac.ir Comments:
public Farhad Heydari
No 7, Aria Building, Sohrevardi Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3776 9818 drfarhadheydari@gmail.com Esfahan University of Medical Sciences scientific Farhad Heydari
No 7, Aria Building, Sohrevardi Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3776 9818 drfarhadheydari@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adult patients referred to the emergency department Known patient with renal colic or typical renal colic pain Severe pain (VAS> 5) Age less than 65 years Informed consent to participate in the study 18 years 65 years Both History of hypertension Patients with heart failure, liver and kidney failure History of analgesic use within 6 hours before the admission History of drug addiction Pregnant patients Patients with decreased level of consciousness Patients with unstable vital signs Hypersensitivity to desmopressin, ketamine and morphine N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Placebo Intervention group: They will be received nasal desmopressin at a dose of 40 mcg, equivalent to 2 puffs per nose, and ketorolac at a dose of 30 mg / ml. Effective treatment is when the pain is reduced by at least 50% of the initial pain or a score of 3 out of 10 VAS scores. Morphine will be given at a dose of 0.1 mg / kg if the patient's pain does not decrease effectively after 30 minutes of drug administration. Intervention group: They will be received nasal ketamine at a dose of 1 mg/kg, and ketorolac at a dose of 30 mg / ml. Effective treatment is when the pain is reduced by at least 50% of the initial pain or a score of 3 out of 10 VAS scores. Morphine will be given at a dose of 0.1 mg / kg if the patient's pain does not decrease effectively after 30 minutes of drug administration. Control group: They will be received nasal placebo, and ketorolac at a dose of 30 mg / ml. Effective treatment is when the pain is reduced by at least 50% of the initial pain or a score of 3 out of 10 VAS scores. Morphine will be given at a dose of 0.1 mg / kg if the patient's pain does not decrease effectively after 30 minutes of drug administration. The severity of pain. Timepoint: In 10, 30 and 60 minutes after receiving the drug. Method of measurement: Visual Analogue Scale. Side effects. Timepoint: every 10 minutes. Method of measurement: Physical exam. Vital signs (blood oxygen saturation level, pulse rate and respiratory rate per minute). Timepoint: Every 10 minutes. Method of measurement: Physical exam. Esfahan University of Medical Sciences Approved 2021-05-12 Ethics committee of Isfahan University of Medical Science Isfahan University of Medical Science, Hezarjrib Street, Isfahan City Isfahan Isfehan Iran (Islamic Republic of)