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IRCT20120629010133N4 IRCT 2022-07-07 Shahid Beheshti University of Medical Sciences Nebulized naloxone in methadone poisoning The effect of nebulized naloxone in comparison with intravenous naloxone in patients with methadone overdose, a randomized clinical trial study 2022-07-16 anticipated 60 Complete https://irct.ir/trial/64574 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the project we will write the name "Naloxone infusion" and Nebulized naloxone" on 30 papers each. All papers will be folded and inserted into an envelope and all envelopes will be put in a small box and the head nurse will take it. For randomization after recruitment and assessment of eligibility for inclusion & exclusion criteria and no contraindication for initiation of each treatment, the head nurse will be asked to open the envelopes at random and present them to the physician in charge. 2-3 Opioid, Methadone, Poisoning, naloxone infusion, Nebulized naloxone. Intervention 1: Intervention group: naloxone administration by jet nebulizer, using 2/3 of i.v. naloxone in emergency department to avoid re-narcosis. Intervention 2: Control group: naloxone administration by pump infusion or serum set, using 2/3 of i.v. naloxone in emergency department to avoid re-narcosis. 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 Confidentiality of data
public Abbas Edalatkhah
Loghman Hakim Hospital, Kamali Ave, South Karegar
Tehran Iran (Islamic Republic of) 1333625445 +98 21 5540 9534 abbas_edalatkhah@yahoo.com Shahid Beheshti University of Medical Sciences scientific Hossein hassanian-Moghaddam
Loghman Hakim Hospital, Kamali Ave, South Karegar
Tehran Iran (Islamic Republic of) دانشیار +98 21 5540 9534 hassanian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Methadone Overdose >18 and <60 Response to naloxone Opioid dependency Spontaneous respiration 18 years 60 years Both No consent to participate nasal congestion Current catching cold Apnea Intubation T40.3 Poisoning by, adverse effect of and underdosing of methadone Treatment - Drugs Treatment - Drugs Intervention group: naloxone administration by jet nebulizer, using 2/3 of i.v. naloxone in emergency department to avoid re-narcosis Control group: naloxone administration by pump infusion or serum set, using 2/3 of i.v. naloxone in emergency department to avoid re-narcosis O2 Saturation. Timepoint: On admission, then each hour till 6 hours, then each 3 hours. Method of measurement: Pulse oxymetery. PCo2. Timepoint: On admission, then each hour till 6 hours, then each 3 hours. Method of measurement: Blood gasometery. Level of consiousness using Glasgow Coma Scale. Timepoint: On admission, then each hour till 6 hours, then each 3 hours. Method of measurement: Physical Examination. Withdrawal Syndrome using COWS scale. Timepoint: Each 3 hours. Method of measurement: Examination. Shahid Beheshti University of Medical Sciences Approved 2022-06-26 Ethic Commitee of Shahid Beheshti University of Medical Sciences Velenjak Tehran Tehran Iran (Islamic Republic of)