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IRCT20220421054605N1 IRCT 2022-05-31 Shahre-kord University of Medical Sciences study of the analgesic effect of fentanyl, fentanyl with ibuprofen, fentanyl with apotel and fentanyl with ketorolac in patients with renal colic study of the analgesic effect of fentanyl, fentanyl with ibuprofen, fentanyl with apotel and fentanyl with ketorolac on the reduction of pain and duration of hospitalization in patients with renal colic 2022-06-10 anticipated 200 Complete https://irct.ir/trial/63235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 200 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly divided into four groups A (first intervention) , B (second intervention) , C (Third intervention) and D ( fourth intervention). Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the four groups, Blinding description: In this study, fentanyl , ibuprofen , ketorolac and apotel, will be prepared by an emergency medicine specialist and placed in coded packages and delivered daily to the researcher, who will prescribe them without knowing the type of each drug. They do. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 2-3 Renal colic. Intervention 1: Intervention group 1: In this group, fentanyl (Darou Pakhsh Company) with a dose of 50 μg is administered as intravenous infusion. Intervention 2: Intervention group 2: For patients in this group, fentanyl (Darou Pakhsh Company) at a dose of 50 μg and ketorolac (Alborz Company) at a dose of 30 mg is administered intravenously. Intervention 3: Intervention group 3: For patients in this group, fentanyl (Darou Pakhsh Company) with a dose of 50 μg and Apotel (Elixir Company) with a dose of 1 g/100 cc normal saline, will be administered in 20 minutes as intravenous infusion. Intervention 4: Intervention group 4: For patients in this group, fentanyl (Darou Pakhsh Company) with a dose of 50 mcg and ibuprofen (Caspian Company) is administered 300 mg in intravenous infusion. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Abdul Rahim Sane'i Dehkordy
Shahrekord University of Medical Sciences, Kashani street,
Shahre-kord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 zahedifatemeh744@gmail.com Shahre-kord University of Medical Sciences scientific Abdul Rahim Sane'i Dehkordy
Shahrekord University of Medical Sciences, Kashani street,
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 sanei.a@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients over the age of 18 have renal colic have stable hemodynamics(pulse rate(PR)=60-100,systolic blood pressure(SBP)>100,respiratory rate(RR)=8-22,functional oxygen saturation(SPO2)>90%) Have informed consent to participate in this study Don't have any of the following: Pregnancy/Asthma / chronic obstructive pulmonary disease(COPD)/ Intestinal obstruction/ Hypertension and heart failure/ Previous pulmonary surgery of the kidney and urinary tract/ Peptic ulcer/ Gastrointestinal bleeding/ Previous allergies to fentanyl or other analgesics / Loss of consciousness/ Trauma Head and chest/pneumocephalus/pneumothorax/Drug addiction/tenderness and abdominal rebound/Guarding abdomen/menstruation retarded/Use of analgesics in the past 24 hours No liver failure and bilateral renal failure 18 years no limit Both N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, fentanyl (Darou Pakhsh Company) with a dose of 50 μg is administered as intravenous infusion. Intervention group 2: For patients in this group, fentanyl (Darou Pakhsh Company) at a dose of 50 μg and ketorolac (Alborz Company) at a dose of 30 mg is administered intravenously. Intervention group 3: For patients in this group, fentanyl (Darou Pakhsh Company) with a dose of 50 μg and Apotel (Elixir Company) with a dose of 1 g/100 cc normal saline, will be administered in 20 minutes as intravenous infusion. Intervention group 4: For patients in this group, fentanyl (Darou Pakhsh Company) with a dose of 50 mcg and ibuprofen (Caspian Company) is administered 300 mg in intravenous infusion. Pain score. Timepoint: At the beginning of the study and at 5, 10، 15، 20، 25 and 30 minutes after the intervention. Method of measurement: Visual Analogue Scale (VAS). Mean Arterial Pressure. Timepoint: At the beginning of the study and at 5, 10، 15، 20، 25 and 30 minutes after the intervention. Method of measurement: Monitoring device. Hear rate. Timepoint: At the beginning of the study and at 5, 10، 15، 20، 25 and 30 minutes after the intervention. Method of measurement: Monitoring device. Percentage of blood oxygen. Timepoint: At the beginning of the study and at 5, 10، 15، 20، 25 and 30 minutes after the intervention. Method of measurement: Monitoring device. Shahre-kord University of Medical Sciences Approved 2022-01-09 Ethics committee of Shahre-Kord University of Medical Sciences Shahrekord University Of Medical Sciences, Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)