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IRCT20180526039846N1 IRCT 2018-06-03 Ahvaz University of Medical Sciences Effect of intranasal Ketamine in treatment of nephrolithiasis Comparison of the Effectiveness of Intranasal Ketamine vs. Intravenous Ketorolac on Renal Colic Pain in Nephrolithiasis Patients 2018-08-22 anticipated 100 Complete https://irct.ir/trial/31484 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients in two groups of test and control will be done by Block Balanced Randomization (BBR) method. The Randomization Sequence will be generated with using the free website at http://www.randomization.com, Blinding description: The patients know they are participating in a investigation that is aimed to evaluate the analgesic effect of intranasal ketamin on the renal colic but they are not informed that they receive placebo or intranasal ketamin. The physician who evaluates the clinical status of patients and the nurse who injects the drug are not aware of the medication that patients receive. 2 Calculus of kidney. Intervention 1: Single dose of intranasal ketamine (1 mg/kg) and placebo (1 ml) intravenous. Intervention 2: Single dose of ketorolac 30mg (1ml) intravenous injection plus intranasal placebo. 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 more information.
public Ali Khavanin
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Street
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2818 khavanin-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ali Khavanin
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Street
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2818 khavanin-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients 18 years old and older Renal colic pain The renal stone or sand diagnosis had been confirmed by ultrasound or CT scan evidence. Describes pain to be greater than or equal to 5 out of 10 on the visual analog scale (VAS) 18 years no limit Both Allergy or contraindication to Ketamine, ketorolac or other NSAIDs Patients who are hemodynamically unstable Breastfeeding or pregnant mothers Patients with language barriers that are unable to describe their pain The history of opium addiction N20 Calculus of kidney Treatment - Drugs Treatment - Drugs Single dose of intranasal ketamine (1 mg/kg) and placebo (1 ml) intravenous Single dose of ketorolac 30mg (1ml) intravenous injection plus intranasal placebo Renal colic pain. Timepoint: At 0, 5, 15, 30, 45, 60, 75 and 90 minutes after drug administration. Method of measurement: Visual analog scale. Side effects. Timepoint: At 0, 5, 15, 30, 45, 60, 75 and 90 minutes after drug administration. Method of measurement: Clinical observations. Ahvaz University of Medical Sciences Approved 2018-05-05 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)