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IRCT20140524017812N4 IRCT 2023-10-12 Tabriz University of Medical Sciences Comparison of Ketamine and Morphine in Pain Relief Comparison of Intravenous and Intranasal Ketamine and Intravenous Morphine in Pain Relief of Bone Fractures 2023-07-23 anticipated 153 Complete https://irct.ir/trial/71359 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization, patients will be assigned to one of the above-mentioned three groups. The randomization sequence using appropriate block size will be generated by Random Allocation Software and determined by one of the individuals who did not participate in the current research. It is necessary to explain that the aforementioned randomization method reduces the possibility of predicting and manipulating the randomization process by people to zero and will lead to the balance of the size of the groups during and at the end of the study, Blinding description: After the diagnosis of a patient with a bone fracture, the patients are randomly assigned to one of 3 groups. After taking the history and considering the inclusion and exclusion criteria, informed consent will be obtained by the researcher. The drug will be prepared by the researcher. Then the clinical caregiver will use the drugs in the patient without knowing the selected drug. The outcome evaluator will measure the effect of the drug and record it in the form. The data will be entered into SPSS software by the researcher and the statistical consultant will analyze the data. 3 Condition 1: bone fracture pain. Condition 2: bone fracture pain. Condition 3: BONE FRACTURE PAIN. Condition 4: bone fracture pain. Intervention 1: Intervention group: intranasal ketamine. in this group, they will receive 1mg/kg nasal ketamine along with 1 cc of normal saline intravenously. Ketamine is manufactured by PANPHARMA, Germany. And it will enter the nostrils in the form of a spray and macrodroplet. The drug will be injected by the researcher or the patient's nurse. After the drug injection, the pain level will be measured by the clinical evaluator at 15, 30 and 60 minutes. Intervention 2: Intervention group: intravenous ketamine. In this group, ketamine 0.5mg/kg will be given intravenously along with 4 puffs of normal saline nasal spray. Ketamine is manufactured by PANPHARMA, Germany. The drug will be injected by the researcher or the patient's nurse. After the drug injection, the pain level will be measured by the clinical evaluator at 15, 30 and 60 minutes. Intervention 3: Control group: intravenous morphine. For the intravenous morphine group, morphine 0.1mg/kg intravenously will be used along with 4 puffs of normal saline spray. Morphine is manufactured by Daropakhsh Iran. The drug will be injected by the researcher or the patient's nurse. After the drug injection, the pain level will be measured by the clinical evaluator at 15, 30 and 60 minutes. Yes - There is a plan to make this available What will be shared: The demographic data of the patients and the outcome will be published in the form of an article. When: After the article is published, access to the data will be possible. To whom: all researchers Conditions: nothing Where to obtain: contact with me. How to obtain: The information will be accessible after obtaining the permission of the research vice-chancellor of the university and sending the permission to myself. Comments:
public Gholamreza Faridaalaee
Daneshgah street
Tabriz Iran (Islamic Republic of) 5166813390 +98 41 3382 9540 grf.aalae@yahoo.com Tabriz University of Medical Sciences scientific Gholamreza Faridaalaee
Daneshgah street
Tabriz Iran (Islamic Republic of) 5166813390 +98 41 3382 9540 grf.aalae@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) all patients with bone fracture who refer the emergency ward. 18 years no limit Both previous use of analgesic head trauma or loss of consciousness counterindication to ketamine such as heart disease, ICP rise, hepatic failure, psychosis, pregnancy allergy to ketamine counterindication to morphine such as (respiratory depression, asthma, use of monoamine oxidase inhibitors, opioid abuse, gastrointestinal obstruction) allergy to morphine Lack of consent to participate in the study Hepatic failure pregnancy S42 S32 S82 S72 Fracture of shoulder and upper arm Fracture of lumbar spine and pelvis Fracture of lower leg, including ankle Fracture of femur Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: intranasal ketamine. in this group, they will receive 1mg/kg nasal ketamine along with 1 cc of normal saline intravenously. Ketamine is manufactured by PANPHARMA, Germany. And it will enter the nostrils in the form of a spray and macrodroplet. The drug will be injected by the researcher or the patient's nurse. After the drug injection, the pain level will be measured by the clinical evaluator at 15, 30 and 60 minutes. Intervention group: intravenous ketamine. In this group, ketamine 0.5mg/kg will be given intravenously along with 4 puffs of normal saline nasal spray. Ketamine is manufactured by PANPHARMA, Germany. The drug will be injected by the researcher or the patient's nurse. After the drug injection, the pain level will be measured by the clinical evaluator at 15, 30 and 60 minutes. Control group: intravenous morphine. For the intravenous morphine group, morphine 0.1mg/kg intravenously will be used along with 4 puffs of normal saline spray. Morphine is manufactured by Daropakhsh Iran. The drug will be injected by the researcher or the patient's nurse. After the drug injection, the pain level will be measured by the clinical evaluator at 15, 30 and 60 minutes. Pain. Timepoint: 0-15-30-60 minute. Method of measurement: 0-10 pain scale. Tabriz University of Medical Sciences Approved 2023-01-23 Ethics Committee of Tabriz University of Medical Sciences daneshgah street tabriz East Azarbaijan Iran (Islamic Republic of)