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IRCT20220305054196N3 IRCT 2023-05-18 Shahid Beheshti University of Medical Sciences Comparison of the effects of two drugs, clonidine and dexmethodomidine, in the treatment of opiate withdrawal syndrome Comparison of the effects of two drugs, clonidine and dexmethodomidine, in the treatment of opiate withdrawal syndrome in patients admitted to the Toxicology ICU of Luqman Hakim Hospital from 2023 to 2025 2023-05-21 anticipated 52 Complete https://irct.ir/trial/70145 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of the block randomization type. The size of all the blocks is equal and we will have 13 blocks in this two-group trial, and considering 4 blocks, a total of 52 patients will be evaluated. The randomization tool will be random allocation software. 3 Opium withdrawal syndrome. Intervention 1: Intervention group: In the first group, dexmethodomidine drug at the rate of 0.5 micrograms/kg manufactured by Elixir Pharmaceutical Company will be used. Intervention 2: Intervention group: The second group will be treated with clonidine up to 1.2 mg per day manufactured by Elixir Pharmaceutical Company . 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 Azade Memarian
Toxicological Research Center, Loghman Hakim Hospital, Kamali Ave, South Kargar St, Tehran
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 8175 A.memarian@gmail.com Shahid Beheshti University of Medical Sciences scientific Mitra Rahimi
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 mrahimi744@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with opium addiction Hospitalization in the poisoning ICU With age minimum 18 and maximum 75 years who have suffered withdrawal syndrome during hospitalization 18 years 75 years Both Lack of consent of the patient to participate in the evaluation Contraindications to clonidine or dexmethodomidine F11.23 Opioid dependence with withdrawal Treatment - Drugs Treatment - Drugs Intervention group: In the first group, dexmethodomidine drug at the rate of 0.5 micrograms/kg manufactured by Elixir Pharmaceutical Company will be used. Intervention group: The second group will be treated with clonidine up to 1.2 mg per day manufactured by Elixir Pharmaceutical Company . Symptoms of Opium withdrawal syndrome. Timepoint: Before drug administration and 12 and 24 hours later. Method of measurement: Based on COWS checklist criteria. Shahid Beheshti University of Medical Sciences Approved 2023-04-15 Ethics Committee of Shahid Beheshti University of Medical Sciences Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran Tehran Tehran Iran (Islamic Republic of)