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IRCT20130108012072N11 IRCT 2020-10-22 Esfahan University of Medical Sciences Clonidine efficacy in acute renal colic Effect of adding oral clonidine to standard treatments on pain intensity of patients with acute renal colic 2019-09-23 anticipated 200 Complete https://irct.ir/trial/50241 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group . The researcher begins to read the numbers in a predetermined manner and the patients are divided, Blinding description: Drugs are prepare with scientist and labeled (scientist is blinded to patient's treatment group and efficacy or complications of each groups). Patients are selected with randomized numeric table and don't aware about treatment protocol. Manager use treatment pathway base on patient randomization; blinded about drug that be used and record result and complications. 3 Acute renal colic. Intervention 1: Intervention group 1: 0.1 mg/kg Morphine diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of 0.2 mg oral Clonidine. Intervention 2: Intervention group 2: 30 mg Ketorolac diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of 0.2 mg oral Clonidine. Intervention 3: Control group 1: 0.1 mg/kg Morphine diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of oral Placebo. Intervention 4: Control group 2: 30 mg Ketorolac diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of oral Placebo. Yes - There is a plan to make this available What will be shared: Whole of data after coding When: Accessibility after 2021 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 m_esmailian@med.mui.ac.ir Comments:
public Mehrdad Esmailian
Alzahra hospital, Sofeh Blv.
Isfahan Iran (Islamic Republic of) 8175898595 +98 31 3620 2085 m_esmailian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Esmailian
Alzahra hospital, Sofeh Blv.
Isfahan Iran (Islamic Republic of) 8175898595 +98 31 3620 2085 m_esmailian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Agreement for entering to the study No Mental Retardation Non pregnant No breast feeding Didn't use of analgesic agents since 4 hours ego No sensitivity to Morphine or Ketorolac or Clonidine Blood Pressure >=110/70 mm Hg No history of chronic liver or kidney injury VAS (Visual Analog Score)>4 18 years 55 years Both Analgesic agents use since 4 hours ego History of drug reaction N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 0.1 mg/kg Morphine diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of 0.2 mg oral Clonidine Intervention group 2: 30 mg Ketorolac diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of 0.2 mg oral Clonidine Control group 1: 0.1 mg/kg Morphine diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of oral Placebo Control group 2: 30 mg Ketorolac diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of oral Placebo Pain severity score with Visual Analog Scale. Timepoint: Study beginning, 20 minutes and 40 minutes after treatment. Method of measurement: Visual Analog Scale. Drug complications. Timepoint: Study beginning, 20 minutes and 40 minutes after treatment. Method of measurement: Standard questionnaire form. Insufficient pain control. Timepoint: 40 minutes after treatment. Method of measurement: Visual Analog Scale. Esfahan University of Medical Sciences Approved 2019-03-13 Ethics committee of Isfahan University of Medical Sciences Alzahra general hospital, Sofeh blv., Isfahan Isfahan Isfehan Iran (Islamic Republic of)