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IRCT20180523039805N1 IRCT 2018-09-01 Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Compare the efficacy of intranasal ketamine and intravenous fentanyl in patients with kidney pain Comparison of the therapeutic effects of intranasal ketamine and intravenous fentanyl in the treatment of patients with renal colic 2018-09-23 anticipated 122 Complete https://irct.ir/trial/31828 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomize in two groups with eight unit Permutational blocks. Permuted block randomization is a way to randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignments. In this case, We will generate the blocks containing 8 number, Blinding description: The patients know they are participating in a study that is aimed to compare the efficacy and side effects of ketamine and Fentanyl in the reduction of renal colic pain but they are not informed that they receive Ketamine or Fentanyl. 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. Intranasal or Intravenous distilled water will be used as a placebo. N/A renal colic. Intervention 1: Intervention group: The group will receive 1 Mg/Kg Ketamine I.V and 1Mg/kg intranasal distilled water. Intervention 2: Intervention group: The group will receive 1Mg / kg fentanyl intranasal and 1 mg/kg intravenous distilled water. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not a plan to make this available
public Seyed alireza Sabouhi
Golestan hospital, Ahwaz, khuzestan province, Iran
Ahwaz Iran (Islamic Republic of) 6455134358 +98 21 2654 4524 Sabouhi.a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Seyed alireza Sabouhi
Golestan hospital, Ahwaz, khuzestan province, Iran
Ahwaz Iran (Islamic Republic of) 6455134358 +98 21 2654 4524 Sabouhi.a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients who suffer from kidney pain caused by kidney stones Patients who have symptoms of nausea, vomiting and Urinary irritation 18 years 55 years Both Opioid dependence History of mental illness Changes in consciousness Get an analgesic for 6 hours before entering the emergency department Unconfirmed renal colic due to the presence of stones History of seizure History of chronic kidney disease Glaucoma Patients under the age of 15 and over 65 years History of chronic liver disease Inability to speak History of allergy to ketamine or fentanyl History of chronic respiratory illness Abnormal brain N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: The group will receive 1 Mg/Kg Ketamine I.V and 1Mg/kg intranasal distilled water Intervention group: The group will receive 1Mg / kg fentanyl intranasal and 1 mg/kg intravenous distilled water Renal colic severity. Timepoint: before intervention and 5, 15 , 30 minutes after intervention. Method of measurement: VAS questionnaire. Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Approved 2018-04-21 Ethical commite of Jundishapur University of Ahvaz Golestan Ahvaz Khouzestan Iran (Islamic Republic of)