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IRCT20180131038569N1 IRCT 2018-04-12 Deputy of Research of Tehran University of Medical Sciences Comparison of intravenous non-vented lidocaine effects in the relief of acute pain in extremity trauma patients Comparison of intravenous non-vented lidocaine effects in the relief of acute pain in extremity trauma patients 2017-08-23 anticipated 32 Complete https://irct.ir/trial/29387 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized, double blind clinical trial. All patients with entry criteria at the time of study are considered to be included in this study. After obtaining written consent and explaining the study conditions, patients are asked to rate their pain levels based on the NRS score. They then randomly enter each of the groups under review. The first group was treated with intravenous morphine (0.1 mg / kg, manufactured by Dr. Distribution Co., Tehran, Iran) and the second group with nevulose lidocaine (10mg / kg in saline (100 mg / ml concentration), Caspian Company Medicine, Rasht, Iran) were treated, Blinding description: The grouping of patients will be based on Balanced Block Randomization in two groups A and B. Both the analgesic drugs are in boxes A and B, and only the physician responsible for the plan (supervisor) is aware of the drug content of each group. In the control group intravenous morphine is selected and at the same time is nebulized distilled water as placebo and in the intervention group,nebulized lidocaine, and at the same time, venous injection distilled water for patients will be prescribed. Then, for use by each supervisor, the numbering is done by the supervisor and what is mentioned in the office. N/A درد حاد در اورژانس. Intervention 1: Intervention group: Lidocaine nebulizer is administered at a dose of 10 mg / kg and is administered intravenously to placebo (distilled water 0.1 cc / kg) for patients. Intervention 2: Control group: Intravenous morphine (0.1 mg / kg) with distilled water as a placebo (10 cc / kg) is nebulized. 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 Because of patient privacy
public Behzad Sadeghi َAmroabadi
Imam Khomeini Hospital,Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417614418 +98 21 61111 B.s1367@yahoo.com Deputy of Research of Tehran University of Medical Sciences scientific Dr Shervin Farahmand
Imam Khomeini Hospital,Keshavarz Blvd
Tehran Iran (Islamic Republic of) Imamhospital@tums.ac +98 21 6658 1618 Shervinf1352@gmail.com Deputy of Research of Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with limb trauma require pain relief with NRS upper 5/10 age between16-65 years 16 years 65 years Both dissatisfaction of patient from this study Patient's allergy to lidocaine or morphine R52 Pain, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Lidocaine nebulizer is administered at a dose of 10 mg / kg and is administered intravenously to placebo (distilled water 0.1 cc / kg) for patients. Control group: Intravenous morphine (0.1 mg / kg) with distilled water as a placebo (10 cc / kg) is nebulized. Intensity of pain. Timepoint: 0,10,20,30,60 minutes. Method of measurement: Numeric Pain Rating Scale. Systolic blood pressure. Timepoint: 0,10,20,30,60minutes. Method of measurement: MmHg. Diastolic blood pressure. Timepoint: 0,10,20,30,60minutes. Method of measurement: MmHg. Heart rate. Timepoint: 0,10,20,30,60minutes. Method of measurement: In a minute. Respiratory rate. Timepoint: 0,10,20,30,60minutes. Method of measurement: In a minute. O2 saturation. Timepoint: 0,10,20,30,60minutes. Method of measurement: percent. Deputy of Research of Tehran University of Medical Sciences Approved 2017-06-12 Ethics Committee of Tehran University of Medical Sciences Imam Khomeini Hospital,Keshavarz Blvd,Tehran Tehran Tehran Iran (Islamic Republic of)