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IRCT20110514006481N14 IRCT 2020-11-28 Semnan University of Medical Sciences Comparison of two methods of naloxone administration on improvement of clinical manifestations in patients with opium poisoning. Comparison effects of two methods of naloxone administration on improvement of clinical manifestations in patients with opium toxicity. 2020-12-21 anticipated 60 Complete https://irct.ir/trial/52571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using stratified permuted block randomization. Patients are divided into two strata of male and female. For each stratum, a separate random assignment continues to reach the sample size. For random assignment in each stratum, four blocks of (A, B), which include different states of test and control sequences (AABB, ABAB …), are used. Block selection and randomization is done with website (URL: https://www.sealedenvelope.com), Blinding description: Because all patients receive oxygen with mask, patients and individuals evaluating response to treatment are unaware of the type of intervention received. But emergency physician, nurses, and researchers are aware of the type of intervention. 3 Opioid dependence. Intervention 1: Intervention group: Administration of naloxone hydrochloride (Tolidaru Pharmaceutical Co, Tehran, Iran) at dose of 2 mg with nebulizer mask that diluted in 3 ml normal saline. Intervention 2: Control group: Naloxone hydrochloride (Tolidaru Pharmaceutical Co, Tehran, Iran) administration intravenously at dose of 0.04 mg diluted in 4 ml normal saline. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Mohsen Soleimani
Nursing faculty, Semnan University of Medical Sciences, 5th Km of Damghan Road
Semnan Iran (Islamic Republic of) 3514799442 0098 23 3354190 Soli257@yahoo.com Semnan University of Medical Sciences scientific Nasim Zamani
Department of emergency, Loghman hospital, south of kargar street, Tehran.
Tehran Iran (Islamic Republic of) 1333625445 +98 21 5541 9005 Soli257@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Known opium toxicity Spontaneous breathing more than 6 breath per minute Age above 15 years old 15 years no limit Both Nose bleeding Unstable hemodynamic Allergy to naloxone F11.22 Opioid dependence with intoxication Treatment - Drugs Treatment - Drugs Intervention group: Administration of naloxone hydrochloride (Tolidaru Pharmaceutical Co, Tehran, Iran) at dose of 2 mg with nebulizer mask that diluted in 3 ml normal saline. Control group: Naloxone hydrochloride (Tolidaru Pharmaceutical Co, Tehran, Iran) administration intravenously at dose of 0.04 mg diluted in 4 ml normal saline. Level of consciousness. Timepoint: 5 min, 10 min, 15 min and 20 min after naloxone administration. Method of measurement: Glasgow Coma Scale. Vital signs. Timepoint: 5 min, 10 min and 20 min after naloxone administration. Method of measurement: Ward monitor. Clinical opiate withdrawal signs. Timepoint: 5 min, 10 min and 20 min after naloxone administration. Method of measurement: Clinical Opiate Withdrawal Scale (COWS). Semnan University of Medical Sciences Approved 2020-09-22 Ethics committee of Semnan University Of Medical Sciences Semnan university of medical sciences, Shahid Akhlaghi intersection, Basij Blvd.,Semnan, Iran. Semnan Semnan Iran (Islamic Republic of)