Investigating the effect of methylphenidate on the level of consciousness in loss of consciousness patients due to poisoning in Loghman Hakim Hospital in Tehran in 2023

Determining the effect of Methylphenidate on the level of consciousness of patients due to poisoning

A clinical trial ,parallel groups, double-blind, randomized using the Random Number Generator v1.4 program - phase 3 on 64 patients

In this study, 64 patients enter the study are randomly divided into two groups of 32 intervention and control. In the intervention group, from the second to the fifth day of hospitalization, methylphenidate with a dose of 20 mg is given orally twice a day for 48 hours- Loghman Hakim Hospital-Blinding of the nurse giving the drug to the identical placebo drug and analyzer will be done.

Inclusion criteria: Age 18 years and above - Informed consent of the patient's legal guardian to participate in the study - Suffering from decreased consciousness due to intoxication (GCS 13 and below) - Having motor ability to measure the motor Criteria for not entering the study: History of sensitivity to Methylphenidate drug - PO intolerance - Unstable vital signs - Pregnancy and breastfeeding in female patients -Receiving specific antidote (for example: flumazenin, naloxone, etc.) - Having mental problems , blindness, deafness - Having a history of brain damage, High blood pressure, Ischemic heart disease - Having epilepsy

Intervention group: Patients with loss of consciousness caused by poisoning (intubated and non-intubated) who receive methylphenidate. Control group: Patients with loss of consciousness due to intoxication receiving standard treatment without methylphenidate

level of consciousness; duration of intubation; receiving antidote;

Randomization will be done using the Random Number Generator v1.4 computer program. a random number between 1 and 64 will be requested after 48 hours of the patient entering the intensive care unit and having the condition of entering the study. which is assigned to the patient, if the patient has an even number, he will be in the control group, and if the patient has an odd number, he will be in the study group. In this way, 32 patients will be in the control group and 32 patients will be in the intervention group. For even patients, from box 1 And for odd patients, medicine will be given from box 2. The researcher and the nurse giving the medicine are unaware of the contents of boxes 1 and 2 and do not know which medicine and which is placebo.

Each dose of medicine is individually packaged and has an identification number. Drug and placebo boxes are supplied in completely similar appearance and packaging, which will cause blinding of participants, researchers and outcome assessors.

All data can be shared after de-identification - Used forms -Raw data - Informed consent form - Statistical analysis

Data are immediately and permanently accessible after article publication—Data will be archived at the Center for Poisoning Research.

All researchers who intend to conduct similar research

All researchers working in academic medical centers and medical treatment centers and pharmaceutical centers who intend to conduct similar research

Loqhman Hakim Hospital - Poisoning Research Center Address : Loghman Hakim Hospital-Makhsous Ave-District 10-Tehran-Iran Tel:00982151025000 Postal Code:1333635445 The request will be reviewed in writing or by email after the authentication of the researcher. Toxicorc@sbmu.ac.ir

Applying to the poisoning research center in writing and in person or by email and then presenting a valid identification document for authentication and having a valid letter of introduction from an academic or medical or pharmaceutical center Toxicorc@sbmu.ac.ir