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IRCT20200708048062N1 IRCT 2020-08-10 Arak University of Medical Sciences The effect of oxycodone on limb fracture pain Comparison of the effect of morphine and oxycodone on pain in patients with limb fractures 2020-08-15 anticipated 92 Complete https://irct.ir/trial/50173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 92 patients were divided into two completely equal groups using morphine and oxycodone using block randomization method. Block randomization method with quadratic block size was used to divide patients into two groups. In this way, using online software (sealedenvelope), the randomization sequence was generated in a block method and remained with the epidemiologist. Following patient diagnosis and based on the generated randomization sequence, a decision was made to assign individuals to groups, Blinding description: Due to the two-sided blindness of the study, in this study, only the relevant specialist in charge of the study (Dr. Solhi, Dr. Azami) is aware of the type of study and the study groups, while patients are of the prescribed drug type. They are not aware. Also, the intern in charge of the project who is in charge of filling out the checklists is not aware of the type of groups based on the prescription drug and only recognizes the groups based on A and B and fills out the checklists accordingly. In the first group, 46 patients receive injectable morphine and placebo, and in the second group, 46 patients receive oral oxycodone and injectable placebo. Receiving the drug after surgery and immediately after transferring the patient to the ward by the responsible intern will be based on group A and B drugs (previously prepared by the main executor of the project) and without mentioning the name of the drug. 3 Condition 1: Tibial fracture. Condition 2: Tibial fracture. Condition 3: Tibial fracture. Condition 4: Femoral bone fracture. Intervention 1: Intervention group1: 46 patients with lower limb fractures (femur and tibia) immediately after surgery and transferred to the inpatient department of morphine sulfate 5 mg intravenously and 2 oral placebo tablets at the same time to control pain Patients with a VAS score above 5 will be treated according to the standard protocol and excluded from the study, and their number will be recorded in the study. Patients were also evaluated for blood pressure and respiratory level and in case of hypotension, bradycardia, decreased respiratory level and bone fractures will be excluded from the study and their number will be recorded in the study. Intervention 2: Intervention group2: 46 patients with lower limb fractures (femur and tibia) Immediately after surgery and transfer to the hospital ward once, 2 oxycodone 5 mg tablets simultaneously and orally and intravenously injectable placebo to control pain Patients with a VAS score above 5 will be treated according to the standard protocol and excluded from the study, and their number will be recorded in the study. Patients were also evaluated for blood pressure and respiratory level and in case of hypotension, bradycardia, decreased respiratory level and bone fractures will be excluded from the study and their number will be recorded in the study. 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 more information
public Pouria Rezae
Payambar-e-azam Complex, Basij Sq., Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 research@arakmu.ac.ir Arak University of Medical Sciences scientific Pouria Rezae
Payambar-e-azam Complex, Basij Sq., Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 research@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) All patients whose bone fractures of the lower extremity (tibia and femur) are confirmed by graphic and are candidates for analgesia after surgical treatment. Age between 18 to 60 years 18 years 60 years Both opioid addiction hypotension, bradycardia, or decreased respiratory rate. history of diabetes and kidney failure. S82.1 S82.2 S82.3 S72 Fracture of upper end of tibia Fracture of shaft of tibia Fracture of lower end of tibia Fracture of femur Treatment - Drugs Treatment - Drugs Intervention group1: 46 patients with lower limb fractures (femur and tibia) immediately after surgery and transferred to the inpatient department of morphine sulfate 5 mg intravenously and 2 oral placebo tablets at the same time to control pain Patients with a VAS score above 5 will be treated according to the standard protocol and excluded from the study, and their number will be recorded in the study. Patients were also evaluated for blood pressure and respiratory level and in case of hypotension, bradycardia, decreased respiratory level and bone fractures will be excluded from the study and their number will be recorded in the study. Intervention group2: 46 patients with lower limb fractures (femur and tibia) Immediately after surgery and transfer to the hospital ward once, 2 oxycodone 5 mg tablets simultaneously and orally and intravenously injectable placebo to control pain Patients with a VAS score above 5 will be treated according to the standard protocol and excluded from the study, and their number will be recorded in the study. Patients were also evaluated for blood pressure and respiratory level and in case of hypotension, bradycardia, decreased respiratory level and bone fractures will be excluded from the study and their number will be recorded in the study. Intensity of pain. Timepoint: Before the intervention and 30 minutes, 2 hours and 6 hours after the intervention. Method of measurement: Visual Analogue Scale of Pain. Arak University of Medical Sciences Approved 2020-07-12 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Basij Sq., Sardasht Town Arak Markazi Iran (Islamic Republic of)