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IRCT20150110020624N2 IRCT 2021-09-11 Shahid Beheshti University of Medical Sciences Fentanyl versus Methadone and treatment of Withdrawal Syndrome In addicted patients admitted to toxicology ICU Fentanyl versus Methadone in the Treatment of Withdrawal Syndrome of Addicted Patients Admitted to Toxicology ICU 2020-11-20 anticipated 50 Complete https://irct.ir/trial/58551 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Only the patients will be blinded to the type of treatment they are being given as they are unconscious and intubated. 2-3 Withdrawal syndrome. Intervention group: The patients are put on fentanyl with the initial dose of 50-100 microg/h. This dose will eventually be adjusted based on the patient response and alleviation of the signs and symptoms of withdrawal.. Yes - There is a plan to make this available What will be shared: The patients' data and analysis data are available and can be used after anonymization of them. When: After publication of the data To whom: Anyone needing the data for scientific and academic purposes Conditions: The data can be used for any scientific purpose with mentioning the source of the data Where to obtain: Nasim Zamani How to obtain: None- Emailing the abovementioned person Comments:
public Nasim Zamani
27 Arbor Walk Lane
Rancho Santa Margarita United States of America 92688 +1 949-320-3264 nasim.zamani@gmail.com Shahid Beheshti University of Medical Sciences scientific Nasim Zamani
27 Arbor Walk Lane
Rancho Santa Margarita United States of America 92688 +1 494 320 3264 nasim.zamani@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Addicted patients who are intubated and admitted to toxicology ICU are those with potential inclusion criteria. If their signs and symptoms of withdrawal initiate during ICU stay (with any severity of withdrawal) they will be included. Addiction will be confirmed by the history taken from the patients’ next of kin, positive urine tests, and initiation of clinical opiate withdrawal syndrome determined by clinical opiate withdrawal scale (COWS). 18 years no limit Both Patients with any other dependencies (such as dependency to benzodiazepines, SSRIs, etc) will be excluded. Patients who receive any medication for control of the addiction before initiation of the withdrawal signs and symptoms, will also be excluded. F11.23 ICD-10 F11.23 is a billable code used to specify a medical diagnosis of opioid dependence with withdrawal. Treatment - Drugs Intervention group: The patients are put on fentanyl with the initial dose of 50-100 microg/h. This dose will eventually be adjusted based on the patient response and alleviation of the signs and symptoms of withdrawal. Time to alleviation of withdrawal syndrome and the potency of treatment performed based on COWS scale. Timepoint: 0.5 and 2 hours post administration. Method of measurement: COWS Scale (Clinical Opiate Withdrawal Scale). Time to extubation- Development of complications. Timepoint: 1 and 2 weeks after ICU admission. Method of measurement: Observation. Shahid Beheshti University of Medical Sciences Approved 2020-08-09 Shahid Beheshti University of Medical Sciences Yaman Street- Velenjak Tehran Tehran Iran (Islamic Republic of)