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IRCT20150217021121N4 IRCT 2020-04-28 Tabriz University of Medical Sciences The effect of diphenhydramine on recovery complications in tempolanoplasty surgery. The effect of pre-treatment with diphenhydramine on the complications of recovery in minor ear, nose and throat surgeries (tympanoplasty). 2020-04-20 anticipated 100 Complete https://irct.ir/trial/47074 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software, Blinding description: The anesthesiologist who is responsible for the patients management to induce anesthesia will administer the medicine(s) via coded syringes which have been prepared previously and therefore he/she will not be aware of the injected drug. Meanwhile the anesthesia nurse who is responsible for collection of patients' information and study variables and is unaware of the administered drug will fill the check- list during surgery and in the recovery room. Also the patient is unaware of the injected medicine. 3 Condition 1: Postoperative nausea and vomiting. Condition 2: Postoperative pain. Intervention 1: Intervention group:In this group, 25 mg of diphenhydramine will be injected before the start of anesthesia. Intervention 2: Control group:In this group only 5 cc normal saline (as a placebo) will be injected completely with the specifications of the drugs of the intervention group before the start of anesthesia. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD, IPD collected for the primary outcome measure are to be shared When: Starting 6 months after publication To whom: Documents will be available for people working in academic institutions and also people working in businesses. Conditions: There will be no specific limitations to the utilization of the data . Where to obtain: Dr .Reza Movassaghi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 413 3341994 Fax+98 41 33341994 rz_movassaghi@yahoo.com How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Reza Movvassaghi
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 rz_movassaghi@yahoo.com Tabriz University of Medical Sciences scientific Reza Movvassaghi
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 rz_movassaghi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Conscious patients over the age of 18 with ASA grade,class I&II Lack of sensitivity to the study drug 18 years no limit Both Having middle ear disease Patients with a history of pelvic surgery History of nausea and vomiting over the past 24 hours Pregnant and breastfeeding woman Y84 T88.59 Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Other complications of anesthesia Treatment - Drugs Treatment - Drugs Intervention group:In this group, 25 mg of diphenhydramine will be injected before the start of anesthesia. Control group:In this group only 5 cc normal saline (as a placebo) will be injected completely with the specifications of the drugs of the intervention group before the start of anesthesia. Severity of postoperative nausea and vomiting. Timepoint: Recovery and at 3, 6, 12,18 and 24 hours postoperatively. Method of measurement: scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times). Severity of postoperative pain. Timepoint: Recovery and at 3, 6, 12,18 and 24 hours postoperatively. Method of measurement: Four Numerical Verbal Rating Scale. Tabriz University of Medical Sciences Approved 2020-03-09 Ethics committee of Tabriz University of Medical Sciences Faculity of Medicine, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)