]>
IRCT20120215009014N341 IRCT 2020-03-03 Hamedan University of Medical Sciences Effect of paracetamol and ketorolac versus paracetamol and ibuprofen on the pain in patients with renal colic Effect of paracetamol and ketorolac versus paracetamol and ibuprofen on the pain in patients with renal colic: a triple-blind randomized clinical trial 2020-01-30 anticipated 80 Complete https://irct.ir/trial/45586 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Thus, the trial will be run as triple-blind. 2 Renal colic. Intervention 1: Intervention group 1: Intravenous injection of ketorolac 30 mg (manufactured by Alborz Pharmaceutical Co.) with 10 ml distilled water plus intravenous infusion of paracetamol 1 g (manufactured by Abidi Pharmaceutical Co.) with 100 ml serum normal saline. Intervention 2: Intervention group 2: Intravenous injection of ibuprofen 400 mg (manufactured by Abidi Pharmaceutical Co.) with 10 ml distilled water plus intravenous infusion of paracetamol 1 g (manufactured by Abidi Pharmaceutical Co.) with 100 ml serum normal saline. 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 It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Sanaz Farsadnia
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 drsanaz1398@gmail.com Hamedan University of Medical Sciences scientific Dr. Reasoul Salimi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 rasoulsl@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 60 years, Renal colic, Pain score of 5 or higher, Conscious level equal to 15 18 years 60 years Both Pregnancy, Cardiovascular failure, Chronic liver failure, Renal failure, Anemia, Peritonitis, Hemodynamics unsuitability, Sensitivity to morphine or its extension, History of allergy to ketorolac or ibuprofen, Receiving analgesic medications in the past 6 hours N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Intervention group 1: Intravenous injection of ketorolac 30 mg (manufactured by Alborz Pharmaceutical Co.) with 10 ml distilled water plus intravenous infusion of paracetamol 1 g (manufactured by Abidi Pharmaceutical Co.) with 100 ml serum normal saline. Intervention group 2: Intravenous injection of ibuprofen 400 mg (manufactured by Abidi Pharmaceutical Co.) with 10 ml distilled water plus intravenous infusion of paracetamol 1 g (manufactured by Abidi Pharmaceutical Co.) with 100 ml serum normal saline. The severity of renal colic. Timepoint: At the zero, 30, and 60 minutes after the intervention. Method of measurement: By using Visual Analog Scale (VAS). Hamedan University of Medical Sciences Approved 2020-01-25 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)