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IRCT20220822055774N1 IRCT 2022-09-20 Kerman University of Medical Sciences Clinical trial of the effectiveness of oral clonidine on pain severity and morphine requirement in patients with orthopedic fractures Clinical trial of the effectiveness of oral clonidine on pain severity and morphine requirement in patients with orthopedic fractures with history of opioids drug abuse in emergency ward 2022-11-01 anticipated 64 Complete https://irct.ir/trial/65613 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Blocked randomization method will be used to allocate samples to intervention and control groups. In this way, an equal number of participants will enter the intervention and control groups at consecutive but equal intervals. Patients in each group will be divided into 6 blocks of 12 people. In this method, one type of treatment is given to the first block and another type to the second and again the first type to the third block and so on. A nurse who was not involved in the study, entered the patients in one of the two groups based on defined blocks, Blinding description: For blinding in the current study, a double-blind method is used so that 1- the person who checks the results and 2- the person who performs the injections does not know which patient received clonidine and which patient received placebo. to be The person responsible for blinding (emergency nurse) will assign a code (01 to 70) to each patient and record it in the questionnaire. In this way, the intervention group received 0.2 mg of oral clonidine (23) and the control group received the same form of placebo pill. The person responsible for blinding will receive. 2-3 Bone fracture. Intervention 1: Intervention group 1: will receive 0.2 mg of oral clonidine after entering the emergency room. Intervention 2: Control group: They will receive placebo pills from the person responsible for blinding after entering the emergency room. 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 Zahra Rostamipour
Afzalipour Faculty of Medicine, Shahid Bahonar University, end of 22 Bahman Blvd,Kerman
Kerman Iran (Islamic Republic of) 7616914115 31320500 zahra.rostami.poor.2365@gmail.com Kerman University of Medical Sciences scientific Masoume Nazimi Rafi
Afzalipour Faculty of Medicine, Shahid Bahonar University, end of 22 Bahman Blvd., Kerman
Kerman Iran (Islamic Republic of) 7616914115 31320500 m-nazemi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old with bone fractures, and pain score >5 based on VASS History of opioid drug abuse Consent to participate in the study 18 years no limit Both Pregnancy and breastfeeding women History of underlying cardio-pulmonary, renal diseases high blood pressure Thrombocytopenia Asthma Use of narcotics other than morphine The patient's urgent need for blood transfusion or resuscitation M96.6 Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate Treatment - Drugs Treatment - Drugs Intervention group 1: will receive 0.2 mg of oral clonidine after entering the emergency room. Control group: They will receive placebo pills from the person responsible for blinding after entering the emergency room. Pain. Timepoint: Before the intervention and 30 minutes, 1 hour, 3 hours and 6 hours after the intervention. Method of measurement: Visual pain intensity measurement scale. Hemodynamic symptoms (systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation). Timepoint: Before the intervention and 30 minutes, 1 hour, 3 hours and 6 hours after the intervention. Method of measurement: Monitoring device. Kerman University of Medical Sciences Approved 2022-09-10 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences campus, Haft Bagh Alavi, Kerman Kerman Kerman Iran (Islamic Republic of)