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

Determination and comparison of sedation rate in children after oral administration of Midazolam and Ketamine, comparison of the patient's separation score from parents in two groups receiving oral Ketamine and Midazolam, determining and comparing the duration of patient's stay in the hospital in two groups receiving oral Midazolam and Ketamine Oral, Determine the duration to start the relaxation effect in oral Midazolam and Ketamine.

Randomized clinical trial of Phase 3, double blinded, 100-person samples, with parallel groups of Midazolam and Ketamine

This double-blind clinical trial will be conducted at Khatam-ol-Anbia Hospital in Zahedan City. The patient and person who evaluates the symptoms of the patient, will be blinded to treatment group.

Inclusion criteria: Children aged 1 to 7 years who require diagnostic imaging. Exclusion criteria: Associated illnesses such as seizures, heart disease, respiratory disease, respiratory active infections, infectious diseases of the nervous system such as autism and ADHD, imaging duration more than 60 minutes, history of drug allergy to sedative medications, children who have received other sedative medications, taking antibiotics like Erythromycin, which causes metabolism problems, Parental dissatisfaction

In one group, children received 0.5mg / kg of oral Midazolam and the second group received 5mg / kg of oral Ketamine with 20cc cherry juice given to the patient to improve the taste of the drug. After administering the drug, every 10 minutes (up 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 administration of the medication, the sedation level in each group will calculated using the same method.

Sedation

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.

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.

Only part of the information, such as the main outcome information, can be shared.

Start the access period 6 months after printing the results

Data will only be available to researchers in university and academia

Only the use of data is allowed to the idea of future research.

Referring to the university vice chancellor

Data will be available after approval by the university's research director.