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IRCT20210214050351N1 IRCT 2021-04-01 Tehran emergency center Comparison of the effect of different doses of paracetamol with ketamine Comparison of the effect of different doses of paracetamol with ketamine in reducing pain in limb trauma patients in the prehospital environment 2021-04-21 anticipated 1200 Complete https://irct.ir/trial/54309 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the fact that individual randomization is not possible for patients as well as blinding technicians in an emergency stations for the type of intervention, randomization will be done in a cluster unit and for the emergency stations. In this method, 12 emergency stations are selected from the emergency stations of Tehran Emergency Center and randomization study will be performed for 4 arms by block randomization method and using Stata v14 software. In such a way that after preparing a list of 12 emergency stations and assigning codes 1 to 4 for each of the study arms, 3 emergency stations randomization for IM ketamine injection, 3 emergency stations IV ketamine injection, 3 emergency stations acetaminophen with dose of 1 gram and 3 emergency stations for acetaminophen with dose of 2 grams. In each of the station will inject the same drug given for all patients that specialized with the conditions of admission to the study. All site technicians will be kept unaware of the type of intervention that is taking place at other stations. Sampling in the station will continue until reaching 300 people in each group (specified sample size), Blinding description: Due to the fact that it is not possible to blind the technicians in a database for the type of intervention, cluster randomization will be done for the database and so blinding will also be done at the emergency stations level. So that the technicians of each emergency stations participating in the study will be kept unaware of the type of intervention of the other emergency stations and they will not be informed which other emergency stations participate in this study and what kind of intervention and medication they use. 3 Limb trauma. Intervention 1: Intervention group 1: IM ketamine injection, 3 mg per kg body weight, once, if needed and no pain relief 30 mg intravenous Ketorolac‎, Manufacturer: Sina Pakhsh Saba. Intervention 2: Intervention group 2: IV ketamine injection, 0.5 mg per kg body weight for 2-3 minutes, once, if needed and no pain relief 30 mg intravenous Ketorolac‎, Manufacturer: Sina Pakhsh Saba. Intervention 3: Intervention group 3: Acetaminophen at a dose of 2 g dissolved in 100 cc of normal saline for 15 minutes, once, if needed and without pain relief 30 mg intravenous ketorolac, manufacturer: Exir Pharmacy. Intervention 4: Control group: Acetaminophen at a dose of 1 g dissolved in 100 cc of normal saline for 15 minutes, once, if needed and without pain relief 30 mg intravenous ketorolac, manufacturer: Exir Pharmacy. 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 no assurance from financial support
public Mojgan Rahimi
Imam Khomeini Hospital Complex, Dr Gharib St., Keshavarz Blvd., Tehran Keshavarz
Tehran Iran (Islamic Republic of) 1419733133 +98 21 6119 2316 dr.mojganrahimii@gmail.com Tehran University of Medical Sciences scientific Mojgan Rahimi
Imam Khomeini Hospital Complex, Dr Gharib St., Keshavarz Blvd., Tehran Keshavarz
Tehran Iran (Islamic Republic of) 1419733133 +98 21 6119 2316 dr.mojganrahimii@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with acute limb trauma Weight between 50-115 kg Systolic blood pressure over than 90 mm Hg Visual Pain Scale over than 3 18 years 70 years Both History of drug abuse Known allergy to ketamine and acetaminophen Alcohol and psychedelics History of liver problems History of seizures GCS less than 14 Multiple trauma patient Instability of vital signs History of cardiac ischemia Pregnant Breastfeeding Blood pressure more than 110/180 G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: IM ketamine injection, 3 mg per kg body weight, once, if needed and no pain relief 30 mg intravenous Ketorolac‎, Manufacturer: Sina Pakhsh Saba Intervention group 2: IV ketamine injection, 0.5 mg per kg body weight for 2-3 minutes, once, if needed and no pain relief 30 mg intravenous Ketorolac‎, Manufacturer: Sina Pakhsh Saba Intervention group 3: Acetaminophen at a dose of 2 g dissolved in 100 cc of normal saline for 15 minutes, once, if needed and without pain relief 30 mg intravenous ketorolac, manufacturer: Exir Pharmacy Control group: Acetaminophen at a dose of 1 g dissolved in 100 cc of normal saline for 15 minutes, once, if needed and without pain relief 30 mg intravenous ketorolac, manufacturer: Exir Pharmacy Pulse rate. Timepoint: Measurement of pulse rate in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: pulseoxymeter. Respiratory rate. Timepoint: Measure the number of breath in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: inspected respiratory rate in one minute. Systolic and diastolic blood pressure. Timepoint: Measurement of systolic and diastolic blood pressure in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: blood pressure cuff. Oxygen saturation rate. Timepoint: Measurement of oxygen saturation in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: pulseoxymeter. Glasgow Coma Scale. Timepoint: Measurement of Glasgow Coma Scale at least 3 time intervals before intervention, 15 and 30 minutes after intervention and at the time of hospital delivery. Method of measurement: Patient examination. Visual Analogue scale. Timepoint: Measurement of visual Analogue scale in at least 3 time intervals before the intervention, 15 and 30 minutes after the intervention and at the time of delivery to the hospital. Method of measurement: ask تغthe patient. Age. Timepoint: at the begining. Method of measurement: ask the patient. Sex. Timepoint: at the begining. Method of measurement: inspection. Type of injury. Timepoint: at the begining. Method of measurement: patient examination. Time duration from intervention till to reaching hospital. Timepoint: at the end of reaching hospital. Method of measurement: duration per hour. Tehran University of Medical Sciences Tehran emergency center Tehran University of Medical Sciences Approved 2021-01-30 Ethics committee of medical faculty of Tehran University of Medical Science Imam Khomeini Hospital Complex, Dr Gharib St., Kheshavarz Blvd., Tehran tehran Tehran Iran (Islamic Republic of)