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IRCT20110629006922N4 IRCT 2019-05-28 Zanjan University of Medical Sciences Effect of Oral Midazolam in Pain relief Effect of Oral Midazolam in Pain relief of patients need Nasogastric Tube insertion:A Clinical Trial Study 2018-10-23 anticipated 200 Complete https://irct.ir/trial/39705 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Due to the presence of pain during insertion of NG Tube and its intolerance in many patients, and the lack of a positive clinical response to thrombocytopenia with lidocaine, as well as the side effects and limitations related to intravenous ketamine and midazolam, we decided This study was conducted to evaluate the effects of oral midazolam in relieving pain in patients requiring ease of administration of NG Tube, Randomization description: Patients are divided into 2-person blocks based on a Random Software Allocation Software (RAS) program, then the two case groups (Midazolam receiving group) and the control group (the group receiving the placebo) will be defined in the software, Blinding description: Patients are randomly divided into two groups based on RAS software. Prepared syrups with the dosage calculated from midazolam and placebo were delivered to the person responsible for the NG Tube and will be administered orally, 20 minutes before the procedure, with a mild administration dose (2 mg). Containers containing midazolam and placebo are pre-coded so that the relevant assistant, patient and NG Tube employs the contents of the dishes. And the placebo is used in terms of color, odor, and appearance of the drug. 3 Effect of oral midazolam on Reduce pain in the time of nasogastric insertion. Intervention 1: Intervention group: Midazolam receiving group; Midazolam syrup, which was made by professors of Pharmacology Department of Tabriz University of Medical Sciences. This syrup is given orally to a patient at a dose of 2 mg 20 minutes before the nasogastric tube is inserted. After insertion, it will be questioned about the severity of pain and the satisfaction of the insertion of this tube. Intervention 2: Control group: Group receiving placebo. Placebo syrup was also made by professors of the Pharmacology Department of Tabriz University of Medical Sciences. The placebo syrup is quite similar to midazolam and its mode of administration is similr midazolam. This syrup is given orally to a patient at a dose of 2 mg 20 minutes before the nasogastric tube is inserted. After insertion, it will be questioned about the severity of pain and the satisfaction of the insertion of this tube. Yes - There is a plan to make this available What will be shared: The whole data after Unidentifiable of patients, will be converted into the article and we try to published it in a reliable Journal When: All data will be released without time limitation. To whom: Results will be available for all groups. Conditions: Data will be available to interested researchers without limitations. Where to obtain: In order to receive the dataŁˆ during communication with the responsible scientific officer, the requested information will be provided to the applicants through his email. How to obtain: With request for Information, it will be sent by email as soon as possible. Comments:
public Ala Rastin
Valiasr Hospital; Valiasr square; Zanjan; Iran
Zanjan Iran (Islamic Republic of) 4515777977 +98 24 3377 0801 ala.rastin@gmail.com Zanjan University of Medical Sciences scientific Ala Rastin
Emergency Department; Valiasr Hospital; Valiasr square; Zanjan; Iran
Zanjan Iran (Islamic Republic of) 4515777977 +98 24 3377 0801 Ala.rastin@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) patients with age 18 - 60 years Indication for Nasogatric tube insertion ( treatment - diagnostic) 18 years 60 years Both decrease level of consciousness allergy to benzodiazepines difficulty of swalloing nausea or vomiting chronic obstructive pulmonary disease pregnancy breastfeeding hypotension ( systolic blood pressure below 90 ) Dissatisfied to participate in the study Y47 Sedatives, hypnotics and antianxiety drugs Treatment - Drugs Treatment - Drugs Intervention group: Midazolam receiving group; Midazolam syrup, which was made by professors of Pharmacology Department of Tabriz University of Medical Sciences. This syrup is given orally to a patient at a dose of 2 mg 20 minutes before the nasogastric tube is inserted. After insertion, it will be questioned about the severity of pain and the satisfaction of the insertion of this tube. Control group: Group receiving placebo. Placebo syrup was also made by professors of the Pharmacology Department of Tabriz University of Medical Sciences. The placebo syrup is quite similar to midazolam and its mode of administration is similr midazolam. This syrup is given orally to a patient at a dose of 2 mg 20 minutes before the nasogastric tube is inserted. After insertion, it will be questioned about the severity of pain and the satisfaction of the insertion of this tube. Pain sensation in visual analog score. Timepoint: Time of nasogastric insertion. Method of measurement: Visual Analogue Scale. Satisfaction with Nasogastric tube insertion. Timepoint: After nasogastric tube insertion. Method of measurement: Visual analogue scale. Zanjan University of Medical Sciences Approved 2018-10-15 Ethics committee of Zanjan University of Medical Sciences Valiasr Square; Sheikh Fazlollah Noori Highway; Educational & Therapeutic Valiasr Center Zanjan Zanjan Iran (Islamic Republic of)