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IRCT20220418054586N1 IRCT 2022-12-04 Ahvaz University of Medical Sciences Comparison of analgesic effect of nebulized Ketamine versus intravenous Morphine in acute pain control Comparison of the analgesic effect of nebulized ketamine versus intravenous morphine in controlling acute pain in patients coming to the emergency department; A randomized controlled clinical trial. 2022-10-12 anticipated 84 Complete https://irct.ir/trial/63786 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the decided drug orders will be written on separate sheets to a certain number and then they will be placed in sealed envelopes and randomly numbered. Then the pockets will be offered to the emergency department doctor so that he can order the analgesic drug based on the order of each pocket. The researcher has to record the patient's name in a separate table along with the number of the pocket and after concluding the data collection, this table will be checked and compared to the numbers and names written on each pocket, Blinding description: Behind the researcher confirms the inclusion criteria and randomly chooses the sample, the patient will be presented to the emergency department doctor to enter the study.The researcher offers the doctor a pocket that has the method of study, and the doctor has to order the analgesic drugs according to the instruction and then covertly write down and record the patient's name in the pocket of related intervention. The doctor also can not give any information about the the drug to the researcher and the patient. In the case group, 1.5 mg per kg of Ketamine will be diluted in 5 ccs of sterile water and nebulized in 5 minutes, and also 100 ccs of Normal saline serum will infuse intravenously for 15 minutes, and in the in control group 0.1 mg per kg Morphine sulfate will be infused intravenously in 100 ccs of Normal saline and also 5 ccs of sterile water will be nebulized; in order to make the trial double-blinded. After prescribing the analgesic drug, the researcher records the patient's name and Visual Analogue Scale in decided minutes on another sheet and table. After concluding the data collection, the recorded data from the pockets and the researcher's table will be conformed to perform the data analysis. 3 Pain. Intervention 1: Intervention group: Patients coming to the ER with pain level greater than 7 out of 10 who get treated by 1.5 mg per kg nebulized ketamine. Intervention 2: Control group: Patients coming to the ER with pain level greater than 7 out of 10 who get treated by 0.1 mg per kg intravenous morphine. 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 There is no more information
public Sahar Gholamzadeh
Golestan Hospital, Mofid Ave., Farvardin Blvd.
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3321 4578 sahar.ghz97@gmail.com Ahvaz University of Medical Sciences scientific Hasan Motamed
Golestan Hospital, Mofid Ave., Farvardin Blvd.
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3374 3001 motamed-h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Acute pain in patients referred to the ER with a Visual analog scale (VAS) equivalent to or greater than 7 out of 10 18 years 60 years Both Having a mental illness mentioned by the patient Head trauma Ischemic heart disease Acute heart failure Respiratory distress Systolic blood pressure greater than 180 mmHg or less than 90 mmHg Asthma High intracranial pressure Pregnancy Addiction Inability to describe the pain Using other analgesics before admission History of being allergic to Ketamine or Morphine or any contraindication of using these drugs G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Patients coming to the ER with pain level greater than 7 out of 10 who get treated by 1.5 mg per kg nebulized ketamine. Control group: Patients coming to the ER with pain level greater than 7 out of 10 who get treated by 0.1 mg per kg intravenous morphine. Pain level. Timepoint: Before intervention and in 5, 10, 20, 40, 60 minutes after intervetion. Method of measurement: Visual Analogue Scale. Side effects. Timepoint: 60 minutes after receiving an intervention. Method of measurement: A questionnaire that includes possible side effects after receiving the drugs. Ahvaz University of Medical Sciences Approved 2022-04-18 Ethics committee of Jondishapour Ahvaz university of medical sciences. Golestan Hospital, Mofid Ave., Farvardin Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)