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IRCT20231213060355N1 IRCT 2023-12-30 Artesh University of Medical Sciences Analgesic Effect of Intravenous Lidocaine in Femoral Fractures Comparison of Venous Infusion of Lidocaine and Intravenous Injection of Pethidine for the Management of Acute Pain Due to Femoral Fractures 2024-01-05 anticipated 72 Complete https://irct.ir/trial/74624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, for the first time we will evaluate the efficacy of infusion of intravenous lidocaine (3 mg/kg/20 minutes) in patients with femoral bone fractures compared to intravenous pethidine (in emergency room). If the intravenous lidocaine shows, Randomization description: Block randomization is used for randomization of participants. We will use www.sealedenvelope.com website for randomization and providing blocks. The block sizs is 4. The treatment groups will be "A" and "B", Blinding description: The list of randomization blocks and treatment groups will be provided to anesthesiologist. Anesthesiologist will define the treatment groups A and B (lidocaine and pethidine). General practitioner, emergency physician, and statistician will not access to the list and they are blinded. Type of treatment groups and drugs (A and B) will not be provided to research contributors, except anesthesiologist. Before enrolment, written informed consent will be obtained from study participants. However, type of drugs will not be provided to patients. At the end of the study, statistician and general physician will analyze the data. 3 Femoral bone fracture. Intervention 1: Intervention group: Intravenous infusion of lidocaine (3 mg/kg during 20 minutes, Maximum dose 200 mg). Intervention 2: Control group: Intravenous pethidine (25 mg). 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 The data supporting the findings of this study are available on request from the corresponding author and with permission from the AJA University of Medical Sciences, Tehran, Iran.
public Mehrshad Namazi
AJA university of medical sciences, Etemadzadeh street, Dr Fatemi street, Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 dr.m.namazi@ajaums.ac.ir Artesh University of Medical Sciences scientific Mehrshad Namazi
AJA university of medical sciences, Etemadzadeh street, Dr Fatemi street, Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 dr.m.namazi@ajaums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age >= 18 years-old Femoral bone fracture Severe pain based on numerical rating scale of pain (NRS) (NRS>=7) 18 years 70 years Both Age > 70 years-old Crush injury of limb and open fractures Acute diseases except of fractures Pregnancy Presence or history of cardiac block or bradycardia Presence or history of seizure Neuromuscular diseases Neuropathic disease Diabetes History of consumption of analgesic or anti-inflammatory drugs History of opioids consumption Allergic history of lidocaine and pethidine S72 Fracture of femur Treatment - Drugs Treatment - Drugs Intervention group: Intravenous infusion of lidocaine (3 mg/kg during 20 minutes, Maximum dose 200 mg) Control group: Intravenous pethidine (25 mg) Numerical Rating Scale of Pain. Timepoint: Before drug administration, 10, 20, 30, 40, 50, 60 minutes after drug administration. Method of measurement: Visual Analogue Scale (VAS) for Pain. Drug adverse events. Timepoint: During the 4 hours after drug administration. Method of measurement: Vital sign monitoring and evaluating the signs and symptoms. Artesh University of Medical Sciences Approved 2023-11-27 Research Ethics Committees of AJA University of Medical Sciences AJA university of medical sciences, Etemad zadeh street, Fatemi-Gharbi Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)