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IRCT20150613022697N8 IRCT 2020-12-02 Mashhad University of Medical Sciences Evaluating the effect of Montelukast on pain following orthognathic surgery. Evaluating the effect of pre-operative administering of oral Montelukast on the pain amount following orthognathic surgery. 2020-10-21 anticipated 60 Complete https://irct.ir/trial/51084 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Since the two groups are supposed to have the same sample size, the restricted randomization method and permuted block randomization will be used in this study. Random block units will usually be used to balance the number of samples assigned to each of the groups studied. The size of blocks will be selected randomly and there is an equal number of each group in each block. Creating a random sequence will be performed by computer software " Random Allocation Software". Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process, Blinding description: In this study, the patient, surgeon, outcome assessor, and statistical analyzer will not be aware of the study groups. Regarding patients, blinding is so that patients will not know if they will receive a drug or a placebo. Regarding the assessor, the operator who delivers the pain questionnaires to the patient and completing the study checklist is not aware of the group assignment. The statistical analyzer will be blinded and all data will be provided in the form of coding to him. Furthermore, the anesthesiologist was aware of the drug types in order to prevent the peri- and postoperative complications. 3 Pain in Jaws. Intervention 1: Intervention group: One dose of 10 mg oral montelukast tablet ( made by Abidi pharmaceutical company under the brand name Airokast) will be dissolved in 20cc of apple juice and will be administered to the patients 1 hour before the surgery. Intervention 2: Control group: Administration of 20cc of natural apple juice in which no drug or substance is dissolved as placebo one hour before the surgery. Yes - There is a plan to make this available What will be shared: All collected data would be shared for all researchers after the participants were unidentified. When: The access to data will be started 6 months after publication To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission Comments:
public Sahand Samieerad
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samieerad
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients suffering from skeletal class 3 deformity, requiring advancement of the maxilla and set back of mandible using Lefort 1 and BSSO (Bilateral Sagittal Split Osteotomy ) technique respectively. Patients between 18 to 40 years old. Patients who are categorized in the 1st and 2nd group according to the ASA (American Society of Anesthesiology ) Patients who completed the informed consent. 18 years 40 years Both Patients with a history of using analgesics or psychiatric medication during the previous month. Patients with a history of addiction or psychological problems . Patients with a history of drug allergy. Patients with a history of severe sinusitis . K10.9 Disease of jaws, unspecified Rehabilitation Placebo Intervention group: One dose of 10 mg oral montelukast tablet ( made by Abidi pharmaceutical company under the brand name Airokast) will be dissolved in 20cc of apple juice and will be administered to the patients 1 hour before the surgery. Control group: Administration of 20cc of natural apple juice in which no drug or substance is dissolved as placebo one hour before the surgery. Amount of pain in the specified time period. Timepoint: 1 hour before the surgery and also 1 ,3 ,6 , 12 , 18 ,and 24 hours after the surgery. Method of measurement: Visual Analogue Scale (VAS). Mashhad University of Medical Sciences Approved 2020-09-02 Ethics committee of Mashhad University of Medical Science Ghoreishi building, Daneshghah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)