Investigating the effect of oral Melatonin premedication on the quality of sedation and pain scale in Cataract surgery

Investigating the effect of oral Melatonin premedication on the quality of sedation and pain scale in Cataract surgery

A clinical trial with a control group, with parallel groups, three blinded, randomized, phase 2 on 40 patients. random allocation software will be used for randomization.

This is a triple-blind randomized clinical trial that will be performed on 40 Cataract candidate patients at Feyz Hospital in Isfahan. After the approval of the university ethics committee, if they have inclusion criteria, patients (or their guardians) will be informed about the study and if they consent, they will enter the groups with random assignment. In each group, the desired intervention is applied and the patient's clinical symptoms are recorded. The clinical caregiver evaluating the symptoms is different from the person performing the intervention and does not know the type of intervention. Patients, despite being studied, are not aware of the type of intervention applied and therefore are all blind. Data analysts also do not know the type of intervention applied in each group and are blind.

Inclusion criteria: over 18 years old, candidate for cataract surgery, and informed consent to enter the study. Non-inclusion criteria: suffering from mental illness, deafness, diabetes, allergies, and obesity

Intervention group A: In this group, patients receive a sublingual tablet containing 3 mg of melatonin 1 hour before surgery. Intervention group B: In this group, patients receive a placebo pill (which is similar to melatonin in terms of color, smell, and appearance) 1 hour before the operation.

intensity of pain

Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number.

This is a triple-blind clinical trial; In this way, before obtaining consent, patients are informed about the study but do not know which group they will be in and therefore are blind. Also, the researcher who records the patient's symptoms is different from the nurse who injects the drug and does not know the type of drug and is blind. Analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind.