Comparison of the effect of midazolam drug with placebo in improving the symptoms of hysterical patients referred to the emergency department

The effect of midazolam on reducing the symptoms of hysteria

The clinical trial has a control group with parallel, three-blind, randomized, phase 3 groups on 80 patients. For randomization, variable block is used. For three-way blinding and hiding the sequence of drugs, they are placed in an envelope with a code and given to the first group, midazolam and placebo (distilled water) to the secound group. Before and after 30 and 60 minutes of the intervention, the variables evaluated.

Patients with hysterical symptoms (restlessness, crying and lack of communication, dysphonia or aphonia) are included in the study after checking the input and output criteria with the Emergency medicine specialist on duty. After randomization, for the group The first ampoule of midazolam of Elixir pharmaceutical company is infused in the amount of 2 cc and the second group of distilled water in the amount of 2 cc is intravenously infused for 2 minutes. In order to blind the patients and the evaluator of the results, drug and placebo are placed in similar syringes in envelopes with numerical codes. For analysis, the information of the drug and placebo groups is given to the data analyst in the form of groups A and B.

Inclusion criteria: All patients with hysteria referred to the emergency room, informed consent of the patient or his companion Exclusion criteria: age less than 18 years and more than 60 years old - pregnancy - history of liver disease - allergy to the study drugs

Intervention group: midazolam ampoule for patients in the amount of 2 mg, which has reached the volume of 2 CCs with distilled water, intravenously within 2 minutes. Control group: intravenous distilled water 2 CCs in 2 minutes.

The presence of symptoms of hysterical patients, drug side effects

The randomization sequence based on variable block size will be obtained from the "Random allocation". To hide the random allocation, coded envelopes are used based on the created random sequence. Inside the envelopes are drugs and placebos based on a random sequence. The envelopes have the same shape, same weight, one They are color. The only codes on the envelopes will indicate the contents of the medicine or placebo.

For triple blinding, drug and placebo are in pre-prepared single-shaped syringes in numbered envelopes. After opening the envelope and assigning the syringe to the patients, the envelope code is written in the patient evaluation form. The patient, the outcome assessor and the data analyst do not know about the contents and codes of the envelopes.

All data of this research can be shared after de-identification.

Access will start one year after the results are published.

Only researchers working in academic and scientific institutions will be allowed to access the data.

Any statistical analysis will be possible for academic researchers to find out the relationship between the variables

Requests should be sent in writing to the responsible author's email.

The claimant sends her /his written request and a valid ID card and employment certificate in a scientific or university institution to the responsible author via email and after the necessary checks, she /he will receive a response to her request within 2 weeks.