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IRCT20200503047291N1 IRCT 2020-08-01 Mashhad University of Medical Sciences Evaluation of dexmedetomidine in reducing postoperative ocular pain Evaluation of the effectiveness of Dexmedetomidine in the assessment of postoperative pain in extra ocular muscle surgery in patients with strabismus 2019-09-23 anticipated 30 Complete https://irct.ir/trial/47670 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization will be done using random numbers table from www.randomization.com website. Randomization concealment will be done using closed envelopes. The envelopes will be prepared and printed by one of the members of the research team and random numbers with the help of Randomaization.com and will be placed inside the envelope. The envelopes are closed and the contents cannot be seen from the outside. Then, the purpose of the study will be explained to the person who meets the inclusion criteria and if the person wishes and signs the informed consent form, takes an envelope and then opens it and enters to the intervention or control group based on the contents of the envelope, Blinding description: Patients and outcome assessors are unaware of patient grouping. A placebo will be used for this purpose. The placebo used in this study looks completely similar to the original drug in terms of appearance and packaging type, so that it is impossible to differentiate it from the main drug. The assessor evaluates the outcome of patients in groups called A and B so that it is not known which patient will be in the control group and which patient will be in the intervention group. 3 Condition 1: Strabismus. Condition 2: Esotropia. Condition 3: Exotropia. Intervention 1: Intervention group: In this group, 30 patients with inclusion criteria who need the strabismus surgery according to strabismus surgical protocols with specific standards, were randomly placed in this group. After the surgery, one microgram per kilogram of patients' weight will be poured at the surgical site with the drug dexmedetomidine, which was manufactured under the brand name Precedex by the HASPPIRA factory in the United States. Intervention 2: Control group: In this group, 30 patients with inclusion criteria who need the strabismus surgery according to strabismus surgical protocols with specific standards, were randomly placed in this group. After the surgery, one microgram per kilogram of patients' weight will be poured at the surgical site with the drug Normal salin, which was manufactured by SAMEN company. Yes - There is a plan to make this available What will be shared: Demographic information and research results When: After submitting the final report. Early in the year 2020 To whom: It will be available to researchers working in academic and scientific institutions. Conditions: In compliance with copyright laws Where to obtain: Call the number and email How to obtain: After submitting the request and reviewing it, they will be answered as soon as possible. (1 week) Comments:
public Hamed Hosseinikhahmanshadi
No.233, 53rd Beheshti Avenue, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9175914785 +98 51 3844 0459 hamed.hosseinikhah@gmail.com Mashhad University of Medical Sciences scientific Hamed Hosseinikhahmanshadi
No233, 53rd Beheshti Avenue, Mashhad
Mashhad Iran (Islamic Republic of) 9175914785 +98 51 3844 0459 hamed.hosseinikhah@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Children over 7 years No other medical problems No history of surgery or manipulation of the extraocular muscles strabismus candidate for extra ocular muscle surgery 7 years no limit Both Patients with drug abuse presence of liver,heart or renal disease unable to answer questions of checklist H50.9 H50.00 H50.1 Unspecified strabismus Unspecified esotropia Exotropia Treatment - Drugs Treatment - Drugs Intervention group: In this group, 30 patients with inclusion criteria who need the strabismus surgery according to strabismus surgical protocols with specific standards, were randomly placed in this group. After the surgery, one microgram per kilogram of patients' weight will be poured at the surgical site with the drug dexmedetomidine, which was manufactured under the brand name Precedex by the HASPPIRA factory in the United States. Control group: In this group, 30 patients with inclusion criteria who need the strabismus surgery according to strabismus surgical protocols with specific standards, were randomly placed in this group. After the surgery, one microgram per kilogram of patients' weight will be poured at the surgical site with the drug Normal salin, which was manufactured by SAMEN company. The amount of postoperative pain. Timepoint: In the designated hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours of surgery, the patient's pain rate was assessed using VAS (Visual analogue scale). Method of measurement: Visual Analogue Scale. Mashhad University of Medical Sciences Approved 2020-04-22 Ethics Committee in Research of Mashhad University of Medical Sciences Mashhad Medical University, Azadi Square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)