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IRCT20171030037093N25 IRCT 2019-12-04 Esfahan University of Medical Sciences The effect of fentanyl with ketamine on pain relief of methadone users The comparison effect of intravenous fentanyl with low dose ketamine on pain relief in methadone user patients with limb fracture 2019-09-11 anticipated 100 Complete https://irct.ir/trial/41773 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The study sample was simple randomly divided into two groups of 20 people, each by selective envelopes. Thus, each envelope containing one of the two A and B labels represented one of the groups, Blinding description: In advance, the two drugs will be prepared by an emergency medicine specialist and will be identified in packages with codes A and B so that the prescriber is not aware of the type of intervention. 3 limb fracture. Intervention 1: First intervention group: receives Fentanyl ampoules made by Aburaihan pharmaceutical Co. 1-2 mg/kg as single dose intravenously and slowly for 15 minutes. Intervention 2: Second intervention group: receives Ketamine ampoules made by Aburaihan pharmaceutical Co 0.3 mg/kg diluted with 100 ml normal saline and administered as single dose, intravenously and slowly for 15 minutes. 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 I will decide until finishing the study
public Mohsen Farghani
Negin Complex, Negin Stand, Kui No. 7, Zahid Ave., Taleghani Ave.
Isfahan Iran (Islamic Republic of) 7346181746 36690021 dr.forghani514@yahoo.com Esfahan University of Medical Sciences scientific Mohsen Farghani
Negin Complex, Negin Stand, Kui No. 7, Zahid Ave., Taleghani Ave.
Isfahan Iran (Islamic Republic of) 7346181746 36690021 dr.forghani514@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Methadone users with limb fractures Ages 18 to 65 years Insensitivity to fentanyl and ketamine Maxillofacial failure No pregnancy Lack of severe head trauma and decreased level of consciousness No serious trauma to the chest and abdomen Instability in terms of vital signs No use of psychotropic drugs No history of neuropsychiatric disorders Consent to participate in this study. 18 years 65 years Both Severe hypoxia Treatment - Drugs Treatment - Drugs First intervention group: receives Fentanyl ampoules made by Aburaihan pharmaceutical Co. 1-2 mg/kg as single dose intravenously and slowly for 15 minutes. Second intervention group: receives Ketamine ampoules made by Aburaihan pharmaceutical Co 0.3 mg/kg diluted with 100 ml normal saline and administered as single dose, intravenously and slowly for 15 minutes. Pain score. Timepoint: Before drug administration (at baseline), and at 15, 30 and 60 minutes after drug administration. Method of measurement: Based on Visual analog score from 0 to 10. Esfahan University of Medical Sciences Approved 2019-05-12 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)