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IRCT20180708040396N1 IRCT 2018-07-15 Zahedan University of Medical Sciences Comparison of the effect of oral Midazolam and Ketamine as a sedative in children requiring radiologic action Comparison of oral Midazolam and oral Ketamin as a sedative in pediatric patients need radiological imaging procedures, refer to emergency department of Zahedan khatam Al-Anbia hospital, years 2018-19: A randomized clinical trial for efficacy 2018-07-22 anticipated 100 Complete https://irct.ir/trial/32443 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Children will be divided into two groups. Given the fact that the method of randomization is by blocking method, here the 10-block blocks will randomly be replaced with how patients are placed in blocks. Each block will consist of 5 patients from each group. Due to the gradual entry of patients, a block will be selected first and a card will be selected accordingly, depending on which patient will be in the corresponding group, Blinding description: The patient and the person who evaluates the symptoms of the patient will be blinded to the treatment group. In other words, the participants will be satisfied with the entry into the research, but will be blinded on which treatment group they are going to be. Also, the data collection team that evaluates the outcomes will be blinded to the outcome of the treatment groups. 3 Restlessness. Intervention 1: Intervention group: Midazolam - In this group, children received 0.5mg / kg 0.5 mg of Midazolam (using Midazolam 5 mg / ml) with twenty cc juice to improve the taste of the drug, is given to the patient by the glass. Intervention 2: Intervention group: Ketamine - In this group, children received 5 mg / kg of oral Ketamine (using doses of 50 mg per 10 ml) with twenty cc juice to improve the taste of the medicine, given to the patient by the glass. Yes - There is a plan to make this available What will be shared: Only part of the information, such as the main outcome information, can be shared. When: Start the access period 6 months after printing the results To whom: Data will only be available to researchers in university and academia Conditions: Only the use of data is allowed to the idea of future research. Where to obtain: Referring to the university vice chancellor How to obtain: Data will be available after approval by the university's research director. Comments:
public Mahjobeh Keikha
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5744 mahjobehkeikha@zaums.ac.ir Zahedan University of Medical Sciences scientific Mahjobeh Keikha
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5744 mahjobehkeikha@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Children aged 1 to 7 years who require diagnostic imaging. 1 year 7 years Both Concomitant illnesses such as seizures, heart disease, respiratory diseases and respiratory active infections Infections of the nervous system such as autism, ADHD The imaging time is longer than 60 minutes A history of drug allergy to sedative medicines Children who have received other sedative medications The use of Antibiotics like erythromycin, which causes metabolism problem Parental dissatisfaction R45.1 Restlessness and agitation Treatment - Drugs Treatment - Drugs Intervention group: Midazolam - In this group, children received 0.5mg / kg 0.5 mg of Midazolam (using Midazolam 5 mg / ml) with twenty cc juice to improve the taste of the drug, is given to the patient by the glass. Intervention group: Ketamine - In this group, children received 5 mg / kg of oral Ketamine (using doses of 50 mg per 10 ml) with twenty cc juice to improve the taste of the medicine, given to the patient by the glass. Restlessness. Timepoint: After administering the drug every 10 minutes to 30 minutes, the tranquility level in each group is ranked using the 5-point method and the 3 score is considered as a satisfactory and appropriate sedation level. After administering the drug, the sedation level is grouped in each group using the re-evaluation method. Method of measurement: With a 5-degree scale from restless to sleep, calmness will be measured. Zahedan University of Medical Sciences Approved 2018-05-26 Ethics committee of Zahedan University of Medical Sciences Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)